The EMPOWER-SUSTAIN e-Health Intervention to improve patient activation and self-management behaviours among individuals with Metabolic Syndrome in primary care: study protocol for a pilot randomised controlled trial
Identifieur interne : 000132 ( Pmc/Curation ); précédent : 000131; suivant : 000133The EMPOWER-SUSTAIN e-Health Intervention to improve patient activation and self-management behaviours among individuals with Metabolic Syndrome in primary care: study protocol for a pilot randomised controlled trial
Auteurs : Maryam Hannah Daud ; Anis Safura Ramli ; Suraya Abdul-Razak ; Mohamad Rodi Isa ; Fakhrul Hazman Yusoff ; Noorhida Baharudin ; Mohamed Syarif Mohamed-Yassin ; Siti Fatimah Badlishah-Sham ; Azlina Wati Nikmat ; Nursuriati Jamil ; Hapizah Mohd-NawawiSource :
- Trials [ 1745-6215 ] ; 2020.
Abstract
Epidemiological studies conducted in various parts of the world have clearly demonstrated that metabolic syndrome (MetS) is an increasing global health problem, not only in Western societies but also in Asian populations. Web-based and mobile phone-based self-management applications have been proven to be effective in improving self-management behaviour of patients with MetS components (i.e., diabetes or hypertension). However, evidence is lacking in terms of their effectiveness specifically for patients with MetS. The aim of this pilot study is to evaluate the feasibility and potential effectiveness of the EMPOWER-SUSTAIN Self-Management e-Health Intervention in improving activation and self-management behaviours among patients with MetS. This paper presents the study protocol.
A pilot randomised controlled trial will be conducted in a university primary care clinic. A total of 232 patients aged 18–60 years with MetS will be recruited; 116 will be randomised to receive the EMPOWER-SUSTAIN intervention for 6 months, and another 116 patients will continue with usual care. The EMPOWER-SUSTAIN intervention is a multifaceted chronic disease management strategy based on the Chronic Care Model and persuasive technology theory. It consists of training primary care physicians, nurses and patients to use the EMPOWER-SUSTAIN web-based self-management mobile app, strengthening the patient–physician relationship and reinforcing the use of relevant clinical practice guidelines to guide management and prescribing. The primary outcome is the mean change in patient activation score using the Patient Activation Measure short form Malay version (PAM-13-M) questionnaire. The secondary outcomes include the changes in waist circumference, body mass index, blood pressure, patient physical activity level, eating behaviour, perception of chronic illness care, satisfaction with patient–physician interaction, and perceived absolute 10-year cardiovascular disease risk. Feasibility of implementing the intervention will be evaluated. This includes acceptability of the intervention, estimating the likely rate of participant recruitment and retention, appropriateness of the outcome measures, calculation of sample size, and the intervention’s potential effectiveness.
To our knowledge, this is the first study in Malaysia that aims to determine the feasibility of a multifaceted e-health intervention, as well as to indicate more useful aspects of this intervention for further exploration in a larger trial.
ClinicalTrials.gov,
Url:
DOI: 10.1186/s13063-020-04237-x
PubMed: 32248825
PubMed Central: 7130454
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Maryam Hannah Daud<affiliation><nlm:aff id="Aff1"><institution-wrap><institution-id institution-id-type="GRID">grid.412259.9</institution-id><institution-id institution-id-type="ISNI">0000 0001 2161 1343</institution-id><institution>Institute of Pathology, Laboratory and Forensic Medicine (I-PPerForM),</institution><institution>Universiti Teknologi MARA,</institution></institution-wrap>Sungai Buloh Campus, Jalan Hospital, 47000 Sungai Buloh, Selangor Malaysia</nlm:aff><wicri:noCountry code="subfield">Selangor Malaysia</wicri:noCountry></affiliation><affiliation><nlm:aff id="Aff2"><institution-wrap><institution-id institution-id-type="GRID">grid.412259.9</institution-id><institution-id institution-id-type="ISNI">0000 0001 2161 1343</institution-id><institution>Department of Primary Care Medicine, Faculty of Medicine,</institution><institution>Universiti Teknologi MARA,</institution></institution-wrap>Selayang Campus, 68100 Batu Caves, Selangor Malaysia</nlm:aff><wicri:noCountry code="subfield">Selangor Malaysia</wicri:noCountry></affiliation><affiliation><nlm:aff id="Aff2"><institution-wrap><institution-id institution-id-type="GRID">grid.412259.9</institution-id><institution-id institution-id-type="ISNI">0000 0001 2161 1343</institution-id><institution>Department of Primary Care Medicine, Faculty of Medicine,</institution><institution>Universiti Teknologi MARA,</institution></institution-wrap>Selayang Campus, 68100 Batu Caves, Selangor Malaysia</nlm:aff><wicri:noCountry code="subfield">Selangor Malaysia</wicri:noCountry></affiliation><affiliation><nlm:aff id="Aff1"><institution-wrap><institution-id institution-id-type="GRID">grid.412259.9</institution-id><institution-id institution-id-type="ISNI">0000 0001 2161 1343</institution-id><institution>Institute of Pathology, Laboratory and Forensic Medicine (I-PPerForM),</institution><institution>Universiti Teknologi MARA,</institution></institution-wrap>Sungai Buloh Campus, Jalan Hospital, 47000 Sungai Buloh, Selangor Malaysia</nlm:aff><wicri:noCountry code="subfield">Selangor Malaysia</wicri:noCountry></affiliation><affiliation><nlm:aff id="Aff2"><institution-wrap><institution-id institution-id-type="GRID">grid.412259.9</institution-id><institution-id institution-id-type="ISNI">0000 0001 2161 1343</institution-id><institution>Department of Primary Care Medicine, Faculty of Medicine,</institution><institution>Universiti Teknologi MARA,</institution></institution-wrap>Selayang Campus, 68100 Batu Caves, Selangor Malaysia</nlm:aff><wicri:noCountry code="subfield">Selangor Malaysia</wicri:noCountry></affiliation><affiliation><nlm:aff id="Aff2"><institution-wrap><institution-id institution-id-type="GRID">grid.412259.9</institution-id><institution-id institution-id-type="ISNI">0000 0001 2161 1343</institution-id><institution>Department of Primary Care Medicine, Faculty of Medicine,</institution><institution>Universiti Teknologi MARA,</institution></institution-wrap>Selayang Campus, 68100 Batu Caves, Selangor Malaysia</nlm:aff><wicri:noCountry code="subfield">Selangor Malaysia</wicri:noCountry></affiliation><affiliation><nlm:aff id="Aff1"><institution-wrap><institution-id institution-id-type="GRID">grid.412259.9</institution-id><institution-id institution-id-type="ISNI">0000 0001 2161 1343</institution-id><institution>Institute of Pathology, Laboratory and Forensic Medicine (I-PPerForM),</institution><institution>Universiti Teknologi MARA,</institution></institution-wrap>Sungai Buloh Campus, Jalan Hospital, 47000 Sungai Buloh, Selangor Malaysia</nlm:aff><wicri:noCountry code="subfield">Selangor Malaysia</wicri:noCountry></affiliation><affiliation><nlm:aff id="Aff2"><institution-wrap><institution-id institution-id-type="GRID">grid.412259.9</institution-id><institution-id institution-id-type="ISNI">0000 0001 2161 1343</institution-id><institution>Department of Primary Care Medicine, Faculty of Medicine,</institution><institution>Universiti Teknologi MARA,</institution></institution-wrap>Selayang Campus, 68100 Batu Caves, Selangor Malaysia</nlm:aff><wicri:noCountry code="subfield">Selangor Malaysia</wicri:noCountry></affiliation><affiliation><nlm:aff id="Aff2"><institution-wrap><institution-id institution-id-type="GRID">grid.412259.9</institution-id><institution-id institution-id-type="ISNI">0000 0001 2161 1343</institution-id><institution>Department of Primary Care Medicine, Faculty of Medicine,</institution><institution>Universiti Teknologi MARA,</institution></institution-wrap>Selayang Campus, 68100 Batu Caves, Selangor Malaysia</nlm:aff><wicri:noCountry code="subfield">Selangor Malaysia</wicri:noCountry></affiliation><affiliation><nlm:aff id="Aff3"><institution-wrap><institution-id institution-id-type="GRID">grid.412259.9</institution-id><institution-id institution-id-type="ISNI">0000 0001 2161 1343</institution-id><institution>Department of Population Health & Preventive Medicine,</institution><institution>Faculty of Medicine Universiti Teknologi MARA,</institution></institution-wrap>Sungai Buloh Campus, Jalan Hospital, 47000 Sungai Buloh, Selangor Malaysia</nlm:aff><wicri:noCountry code="subfield">Selangor Malaysia</wicri:noCountry></affiliation><affiliation><nlm:aff id="Aff4"><institution-wrap><institution-id institution-id-type="GRID">grid.412259.9</institution-id><institution-id institution-id-type="ISNI">0000 0001 2161 1343</institution-id><institution>Department of Computer Science, Faculty of Computer and Mathematical Sciences,</institution><institution>Universiti Teknologi MARA,</institution></institution-wrap>40450 Shah Alam, Selangor Malaysia</nlm:aff><wicri:noCountry code="subfield">Selangor Malaysia</wicri:noCountry></affiliation><affiliation><nlm:aff id="Aff2"><institution-wrap><institution-id institution-id-type="GRID">grid.412259.9</institution-id><institution-id institution-id-type="ISNI">0000 0001 2161 1343</institution-id><institution>Department of Primary Care Medicine, Faculty of Medicine,</institution><institution>Universiti Teknologi MARA,</institution></institution-wrap>Selayang Campus, 68100 Batu Caves, Selangor Malaysia</nlm:aff><wicri:noCountry code="subfield">Selangor Malaysia</wicri:noCountry></affiliation><affiliation><nlm:aff id="Aff2"><institution-wrap><institution-id institution-id-type="GRID">grid.412259.9</institution-id><institution-id institution-id-type="ISNI">0000 0001 2161 1343</institution-id><institution>Department of Primary Care Medicine, Faculty of Medicine,</institution><institution>Universiti Teknologi MARA,</institution></institution-wrap>Selayang Campus, 68100 Batu Caves, Selangor Malaysia</nlm:aff><wicri:noCountry code="subfield">Selangor Malaysia</wicri:noCountry></affiliation><affiliation><nlm:aff id="Aff2"><institution-wrap><institution-id institution-id-type="GRID">grid.412259.9</institution-id><institution-id institution-id-type="ISNI">0000 0001 2161 1343</institution-id><institution>Department of Primary Care Medicine, Faculty of Medicine,</institution><institution>Universiti Teknologi MARA,</institution></institution-wrap>Selayang Campus, 68100 Batu Caves, Selangor Malaysia</nlm:aff><wicri:noCountry code="subfield">Selangor Malaysia</wicri:noCountry></affiliation><affiliation><nlm:aff id="Aff5"><institution-wrap><institution-id institution-id-type="GRID">grid.412259.9</institution-id><institution-id institution-id-type="ISNI">0000 0001 2161 1343</institution-id><institution>Department of Psychiatry, Faculty of Medicine,</institution><institution>Universiti Teknologi MARA,</institution></institution-wrap>Sungai Buloh, Campus, Jalan Hospital, 47000 Sungai Buloh, Selangor Malaysia</nlm:aff><wicri:noCountry code="subfield">Selangor Malaysia</wicri:noCountry></affiliation><affiliation><nlm:aff id="Aff4"><institution-wrap><institution-id institution-id-type="GRID">grid.412259.9</institution-id><institution-id institution-id-type="ISNI">0000 0001 2161 1343</institution-id><institution>Department of Computer Science, Faculty of Computer and Mathematical Sciences,</institution><institution>Universiti Teknologi MARA,</institution></institution-wrap>40450 Shah Alam, Selangor Malaysia</nlm:aff><wicri:noCountry code="subfield">Selangor Malaysia</wicri:noCountry></affiliation><affiliation><nlm:aff id="Aff1"><institution-wrap><institution-id institution-id-type="GRID">grid.412259.9</institution-id><institution-id institution-id-type="ISNI">0000 0001 2161 1343</institution-id><institution>Institute of Pathology, Laboratory and Forensic Medicine (I-PPerForM),</institution><institution>Universiti Teknologi MARA,</institution></institution-wrap>Sungai Buloh Campus, Jalan Hospital, 47000 Sungai Buloh, Selangor Malaysia</nlm:aff><wicri:noCountry code="subfield">Selangor Malaysia</wicri:noCountry></affiliation>Le document en format XML
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Campus, Jalan Hospital, 47000 Sungai Buloh, Selangor Malaysia</nlm:aff><wicri:noCountry code="subfield">Selangor Malaysia</wicri:noCountry></affiliation></author><author><name sortKey="Jamil, Nursuriati" sort="Jamil, Nursuriati" uniqKey="Jamil N" first="Nursuriati" last="Jamil">Nursuriati Jamil</name><affiliation><nlm:aff id="Aff4"><institution-wrap><institution-id institution-id-type="GRID">grid.412259.9</institution-id><institution-id institution-id-type="ISNI">0000 0001 2161 1343</institution-id><institution>Department of Computer Science, Faculty of Computer and Mathematical Sciences,</institution><institution>Universiti Teknologi MARA,</institution></institution-wrap>40450 Shah Alam, Selangor Malaysia</nlm:aff><wicri:noCountry code="subfield">Selangor Malaysia</wicri:noCountry></affiliation></author><author><name sortKey="Mohd Nawawi, Hapizah" sort="Mohd Nawawi, Hapizah" uniqKey="Mohd Nawawi H" first="Hapizah" last="Mohd-Nawawi">Hapizah Mohd-Nawawi</name><affiliation><nlm:aff 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47000 Sungai Buloh, Selangor Malaysia</nlm:aff><wicri:noCountry code="subfield">Selangor Malaysia</wicri:noCountry></affiliation><affiliation><nlm:aff id="Aff2"><institution-wrap><institution-id institution-id-type="GRID">grid.412259.9</institution-id><institution-id institution-id-type="ISNI">0000 0001 2161 1343</institution-id><institution>Department of Primary Care Medicine, Faculty of Medicine,</institution><institution>Universiti Teknologi MARA,</institution></institution-wrap>Selayang Campus, 68100 Batu Caves, Selangor Malaysia</nlm:aff><wicri:noCountry code="subfield">Selangor Malaysia</wicri:noCountry></affiliation></author><author><name sortKey="Ramli, Anis Safura" sort="Ramli, Anis Safura" uniqKey="Ramli A" first="Anis Safura" last="Ramli">Anis Safura Ramli</name><affiliation><nlm:aff id="Aff1"><institution-wrap><institution-id institution-id-type="GRID">grid.412259.9</institution-id><institution-id institution-id-type="ISNI">0000 0001 2161 1343</institution-id><institution>Institute of Pathology, Laboratory and Forensic Medicine (I-PPerForM),</institution><institution>Universiti Teknologi MARA,</institution></institution-wrap>Sungai Buloh Campus, Jalan Hospital, 47000 Sungai Buloh, Selangor Malaysia</nlm:aff><wicri:noCountry code="subfield">Selangor Malaysia</wicri:noCountry></affiliation><affiliation><nlm:aff id="Aff2"><institution-wrap><institution-id institution-id-type="GRID">grid.412259.9</institution-id><institution-id institution-id-type="ISNI">0000 0001 2161 1343</institution-id><institution>Department of Primary Care Medicine, Faculty of Medicine,</institution><institution>Universiti Teknologi MARA,</institution></institution-wrap>Selayang Campus, 68100 Batu Caves, Selangor Malaysia</nlm:aff><wicri:noCountry code="subfield">Selangor Malaysia</wicri:noCountry></affiliation></author><author><name sortKey="Abdul Razak, Suraya" sort="Abdul Razak, Suraya" uniqKey="Abdul Razak S" first="Suraya" last="Abdul-Razak">Suraya Abdul-Razak</name><affiliation><nlm:aff id="Aff1"><institution-wrap><institution-id institution-id-type="GRID">grid.412259.9</institution-id><institution-id institution-id-type="ISNI">0000 0001 2161 1343</institution-id><institution>Institute of Pathology, Laboratory and Forensic Medicine (I-PPerForM),</institution><institution>Universiti Teknologi MARA,</institution></institution-wrap>Sungai Buloh Campus, Jalan Hospital, 47000 Sungai Buloh, Selangor Malaysia</nlm:aff><wicri:noCountry code="subfield">Selangor Malaysia</wicri:noCountry></affiliation><affiliation><nlm:aff id="Aff2"><institution-wrap><institution-id institution-id-type="GRID">grid.412259.9</institution-id><institution-id institution-id-type="ISNI">0000 0001 2161 1343</institution-id><institution>Department of Primary Care Medicine, Faculty of Medicine,</institution><institution>Universiti Teknologi MARA,</institution></institution-wrap>Selayang Campus, 68100 Batu Caves, Selangor Malaysia</nlm:aff><wicri:noCountry code="subfield">Selangor Malaysia</wicri:noCountry></affiliation></author><author><name sortKey="Isa, Mohamad Rodi" sort="Isa, Mohamad Rodi" uniqKey="Isa M" first="Mohamad Rodi" last="Isa">Mohamad Rodi Isa</name><affiliation><nlm:aff id="Aff3"><institution-wrap><institution-id institution-id-type="GRID">grid.412259.9</institution-id><institution-id institution-id-type="ISNI">0000 0001 2161 1343</institution-id><institution>Department of Population Health & Preventive Medicine,</institution><institution>Faculty of Medicine Universiti Teknologi MARA,</institution></institution-wrap>Sungai Buloh Campus, Jalan Hospital, 47000 Sungai Buloh, Selangor Malaysia</nlm:aff><wicri:noCountry code="subfield">Selangor Malaysia</wicri:noCountry></affiliation></author><author><name sortKey="Yusoff, Fakhrul Hazman" sort="Yusoff, Fakhrul Hazman" uniqKey="Yusoff F" first="Fakhrul Hazman" last="Yusoff">Fakhrul Hazman Yusoff</name><affiliation><nlm:aff id="Aff4"><institution-wrap><institution-id institution-id-type="GRID">grid.412259.9</institution-id><institution-id institution-id-type="ISNI">0000 0001 2161 1343</institution-id><institution>Department of Computer Science, Faculty of Computer and Mathematical Sciences,</institution><institution>Universiti Teknologi MARA,</institution></institution-wrap>40450 Shah Alam, Selangor Malaysia</nlm:aff><wicri:noCountry code="subfield">Selangor Malaysia</wicri:noCountry></affiliation></author><author><name sortKey="Baharudin, Noorhida" sort="Baharudin, Noorhida" uniqKey="Baharudin N" first="Noorhida" last="Baharudin">Noorhida Baharudin</name><affiliation><nlm:aff id="Aff2"><institution-wrap><institution-id institution-id-type="GRID">grid.412259.9</institution-id><institution-id institution-id-type="ISNI">0000 0001 2161 1343</institution-id><institution>Department of Primary Care Medicine, Faculty of Medicine,</institution><institution>Universiti Teknologi MARA,</institution></institution-wrap>Selayang Campus, 68100 Batu Caves, Selangor Malaysia</nlm:aff><wicri:noCountry code="subfield">Selangor Malaysia</wicri:noCountry></affiliation></author><author><name sortKey="Mohamed Yassin, Mohamed Syarif" sort="Mohamed Yassin, Mohamed Syarif" uniqKey="Mohamed Yassin M" first="Mohamed Syarif" last="Mohamed-Yassin">Mohamed Syarif Mohamed-Yassin</name><affiliation><nlm:aff id="Aff2"><institution-wrap><institution-id institution-id-type="GRID">grid.412259.9</institution-id><institution-id institution-id-type="ISNI">0000 0001 2161 1343</institution-id><institution>Department of Primary Care Medicine, Faculty of Medicine,</institution><institution>Universiti Teknologi MARA,</institution></institution-wrap>Selayang Campus, 68100 Batu Caves, Selangor Malaysia</nlm:aff><wicri:noCountry code="subfield">Selangor Malaysia</wicri:noCountry></affiliation></author><author><name sortKey="Badlishah Sham, Siti Fatimah" sort="Badlishah Sham, Siti Fatimah" uniqKey="Badlishah Sham S" first="Siti Fatimah" last="Badlishah-Sham">Siti Fatimah Badlishah-Sham</name><affiliation><nlm:aff id="Aff2"><institution-wrap><institution-id institution-id-type="GRID">grid.412259.9</institution-id><institution-id institution-id-type="ISNI">0000 0001 2161 1343</institution-id><institution>Department of Primary Care Medicine, Faculty of Medicine,</institution><institution>Universiti Teknologi MARA,</institution></institution-wrap>Selayang Campus, 68100 Batu Caves, Selangor Malaysia</nlm:aff><wicri:noCountry code="subfield">Selangor Malaysia</wicri:noCountry></affiliation></author><author><name sortKey="Nikmat, Azlina Wati" sort="Nikmat, Azlina Wati" uniqKey="Nikmat A" first="Azlina Wati" last="Nikmat">Azlina Wati Nikmat</name><affiliation><nlm:aff id="Aff5"><institution-wrap><institution-id institution-id-type="GRID">grid.412259.9</institution-id><institution-id institution-id-type="ISNI">0000 0001 2161 1343</institution-id><institution>Department of Psychiatry, Faculty of Medicine,</institution><institution>Universiti Teknologi MARA,</institution></institution-wrap>Sungai Buloh, Campus, Jalan Hospital, 47000 Sungai Buloh, Selangor Malaysia</nlm:aff><wicri:noCountry code="subfield">Selangor Malaysia</wicri:noCountry></affiliation></author><author><name sortKey="Jamil, Nursuriati" sort="Jamil, Nursuriati" uniqKey="Jamil N" first="Nursuriati" last="Jamil">Nursuriati Jamil</name><affiliation><nlm:aff id="Aff4"><institution-wrap><institution-id institution-id-type="GRID">grid.412259.9</institution-id><institution-id institution-id-type="ISNI">0000 0001 2161 1343</institution-id><institution>Department of Computer Science, Faculty of Computer and Mathematical Sciences,</institution><institution>Universiti Teknologi MARA,</institution></institution-wrap>40450 Shah Alam, Selangor Malaysia</nlm:aff><wicri:noCountry code="subfield">Selangor Malaysia</wicri:noCountry></affiliation></author><author><name sortKey="Mohd Nawawi, Hapizah" sort="Mohd Nawawi, Hapizah" uniqKey="Mohd Nawawi H" first="Hapizah" last="Mohd-Nawawi">Hapizah Mohd-Nawawi</name><affiliation><nlm:aff id="Aff1"><institution-wrap><institution-id institution-id-type="GRID">grid.412259.9</institution-id><institution-id institution-id-type="ISNI">0000 0001 2161 1343</institution-id><institution>Institute of Pathology, Laboratory and Forensic Medicine (I-PPerForM),</institution><institution>Universiti Teknologi MARA,</institution></institution-wrap>Sungai Buloh Campus, Jalan Hospital, 47000 Sungai Buloh, Selangor Malaysia</nlm:aff><wicri:noCountry code="subfield">Selangor Malaysia</wicri:noCountry></affiliation></author></analytic><series><title level="j">Trials</title><idno type="eISSN">1745-6215</idno><imprint><date when="2020">2020</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><sec><title>Background</title><p id="Par1">Epidemiological studies conducted in various parts of the world have clearly demonstrated that metabolic syndrome (MetS) is an increasing global health problem, not only in Western societies but also in Asian populations. Web-based and mobile phone-based self-management applications have been proven to be effective in improving self-management behaviour of patients with MetS components (i.e., diabetes or hypertension). However, evidence is lacking in terms of their effectiveness specifically for patients with MetS. The aim of this pilot study is to evaluate the feasibility and potential effectiveness of the EMPOWER-SUSTAIN Self-Management e-Health Intervention in improving activation and self-management behaviours among patients with MetS. This paper presents the study protocol.</p></sec><sec><title>Methods</title><p id="Par2">A pilot randomised controlled trial will be conducted in a university primary care clinic. A total of 232 patients aged 18–60 years with MetS will be recruited; 116 will be randomised to receive the EMPOWER-SUSTAIN intervention for 6 months, and another 116 patients will continue with usual care. The EMPOWER-SUSTAIN intervention is a multifaceted chronic disease management strategy based on the Chronic Care Model and persuasive technology theory. It consists of training primary care physicians, nurses and patients to use the EMPOWER-SUSTAIN web-based self-management mobile app, strengthening the patient–physician relationship and reinforcing the use of relevant clinical practice guidelines to guide management and prescribing. The primary outcome is the mean change in patient activation score using the Patient Activation Measure short form Malay version (PAM-13-M) questionnaire. The secondary outcomes include the changes in waist circumference, body mass index, blood pressure, patient physical activity level, eating behaviour, perception of chronic illness care, satisfaction with patient–physician interaction, and perceived absolute 10-year cardiovascular disease risk. Feasibility of implementing the intervention will be evaluated. This includes acceptability of the intervention, estimating the likely rate of participant recruitment and retention, appropriateness of the outcome measures, calculation of sample size, and the intervention’s potential effectiveness.</p></sec><sec><title>Conclusion</title><p id="Par3">To our knowledge, this is the first study in Malaysia that aims to determine the feasibility of a multifaceted e-health intervention, as well as to indicate more useful aspects of this intervention for further exploration in a larger trial.</p></sec><sec><title>Trial registration</title><p id="Par4">ClinicalTrials.gov, <ext-link ext-link-type="uri" xlink:href="https://clinicaltrials.gov/ct2/show/NCT04120779">NCT04120779</ext-link>. Registered on 9 October 2019, protocol version 1.</p></sec></div></front><back><div1 type="bibliography"><listBibl><biblStruct><analytic><author><name sortKey="Alberti, Kgmm" uniqKey="Alberti K">KGMM Alberti</name></author><author><name sortKey="Eckel, Rh" uniqKey="Eckel R">RH Eckel</name></author><author><name sortKey="Grundy, Sm" uniqKey="Grundy S">SM Grundy</name></author><author><name sortKey="Zimmet, Pz" uniqKey="Zimmet P">PZ Zimmet</name></author><author><name sortKey="Cleeman, Ji" uniqKey="Cleeman J">JI Cleeman</name></author><author><name sortKey="Donato, Ka" uniqKey="Donato K">KA Donato</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Saklayen, Mg" uniqKey="Saklayen M">MG Saklayen</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="O Eill, S" uniqKey="O Eill S">S O’Neill</name></author><author><name sortKey="O Riscoll, L" uniqKey="O Riscoll L">L 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uniqKey="Bravo P">P Bravo</name></author><author><name sortKey="Edwards, A" uniqKey="Edwards A">A Edwards</name></author><author><name sortKey="Barr, Pj" uniqKey="Barr P">PJ Barr</name></author><author><name sortKey="Scholl, I" uniqKey="Scholl I">I Scholl</name></author><author><name sortKey="Elwyn, G" uniqKey="Elwyn G">G Elwyn</name></author><author><name sortKey="Mcallister, M" uniqKey="Mcallister M">M McAllister</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Hibbard, Jh" uniqKey="Hibbard J">JH Hibbard</name></author><author><name sortKey="Stockard, J" uniqKey="Stockard J">J Stockard</name></author><author><name sortKey="Mahoney, Er" uniqKey="Mahoney E">ER Mahoney</name></author><author><name sortKey="Tusler, M" uniqKey="Tusler M">M Tusler</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Hibbard, Jh" uniqKey="Hibbard J">JH Hibbard</name></author><author><name sortKey="Mahoney, Er" uniqKey="Mahoney E">ER 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M" uniqKey="Tusler M">M Tusler</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Graffigna, G" uniqKey="Graffigna G">G Graffigna</name></author><author><name sortKey="Barello, S" uniqKey="Barello S">S Barello</name></author><author><name sortKey="Bonanomi, A" uniqKey="Bonanomi A">A Bonanomi</name></author><author><name sortKey="Lozza, E" uniqKey="Lozza E">E Lozza</name></author><author><name sortKey="Hibbard, J" uniqKey="Hibbard J">J Hibbard</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Greene, J" uniqKey="Greene J">J Greene</name></author><author><name sortKey="Hibbard, Jh" uniqKey="Hibbard J">JH Hibbard</name></author><author><name sortKey="Sacks, R" uniqKey="Sacks R">R Sacks</name></author><author><name sortKey="Overton, V" uniqKey="Overton V">V Overton</name></author><author><name sortKey="Parrotta, Cd" uniqKey="Parrotta C">CD Parrotta</name></author></analytic></biblStruct><biblStruct><analytic><author><name 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<front><journal-meta><journal-id journal-id-type="nlm-ta">Trials</journal-id><journal-id journal-id-type="iso-abbrev">Trials</journal-id><journal-title-group><journal-title>Trials</journal-title></journal-title-group><issn pub-type="epub">1745-6215</issn><publisher><publisher-name>BioMed Central</publisher-name><publisher-loc>London</publisher-loc></publisher></journal-meta><article-meta><article-id pub-id-type="pmid">32248825</article-id><article-id pub-id-type="pmc">7130454</article-id><article-id pub-id-type="publisher-id">4237</article-id><article-id pub-id-type="doi">10.1186/s13063-020-04237-x</article-id><article-categories><subj-group subj-group-type="heading"><subject>Study Protocol</subject></subj-group></article-categories><title-group><article-title>The EMPOWER-SUSTAIN e-Health Intervention to improve patient activation and self-management behaviours among individuals with Metabolic Syndrome in primary care: study protocol for a pilot randomised controlled trial</article-title></title-group><contrib-group><contrib contrib-type="author"><name><surname>Daud</surname><given-names>Maryam Hannah</given-names></name><address><email>maryamhannahdaud@yahoo.com</email></address><xref ref-type="aff" rid="Aff1">1</xref><xref ref-type="aff" rid="Aff2">2</xref></contrib><contrib contrib-type="author" corresp="yes"><name><surname>Ramli</surname><given-names>Anis Safura</given-names></name><address><email>rossanis_yuzadi@yahoo.co.uk</email><email>anis014@uitm.edu.my</email></address><xref ref-type="aff" rid="Aff1">1</xref><xref ref-type="aff" rid="Aff2">2</xref></contrib><contrib contrib-type="author"><name><surname>Abdul-Razak</surname><given-names>Suraya</given-names></name><address><email>drsuraya.abdulrazak@gmail.com</email></address><xref ref-type="aff" rid="Aff1">1</xref><xref ref-type="aff" rid="Aff2">2</xref></contrib><contrib contrib-type="author"><name><surname>Isa</surname><given-names>Mohamad Rodi</given-names></name><address><email>rodi@uitm.edu.my</email></address><xref ref-type="aff" rid="Aff3">3</xref></contrib><contrib contrib-type="author"><name><surname>Yusoff</surname><given-names>Fakhrul Hazman</given-names></name><address><email>fakhrul@tmsk.uitm.edu.my</email></address><xref ref-type="aff" rid="Aff4">4</xref></contrib><contrib contrib-type="author"><name><surname>Baharudin</surname><given-names>Noorhida</given-names></name><address><email>noorhida1@gmail.com</email></address><xref ref-type="aff" rid="Aff2">2</xref></contrib><contrib contrib-type="author"><name><surname>Mohamed-Yassin</surname><given-names>Mohamed Syarif</given-names></name><address><email>syarif.yassin@gmail.com</email></address><xref ref-type="aff" rid="Aff2">2</xref></contrib><contrib contrib-type="author"><name><surname>Badlishah-Sham</surname><given-names>Siti Fatimah</given-names></name><address><email>fatimabadli@gmail.com</email></address><xref ref-type="aff" rid="Aff2">2</xref></contrib><contrib contrib-type="author"><name><surname>Nikmat</surname><given-names>Azlina Wati</given-names></name><address><email>azlinawatinikmat@gmail.com</email></address><xref ref-type="aff" rid="Aff5">5</xref></contrib><contrib contrib-type="author"><name><surname>Jamil</surname><given-names>Nursuriati</given-names></name><address><email>liza@tmsk.uitm.edu.my</email></address><xref ref-type="aff" rid="Aff4">4</xref></contrib><contrib contrib-type="author"><name><surname>Mohd-Nawawi</surname><given-names>Hapizah</given-names></name><address><email>hapizah.nawawi@gmail.com</email></address><xref ref-type="aff" rid="Aff1">1</xref></contrib><aff id="Aff1"><label>1</label><institution-wrap><institution-id institution-id-type="GRID">grid.412259.9</institution-id><institution-id institution-id-type="ISNI">0000 0001 2161 1343</institution-id><institution>Institute of Pathology, Laboratory and Forensic Medicine (I-PPerForM),</institution><institution>Universiti Teknologi MARA,</institution></institution-wrap>Sungai Buloh Campus, Jalan Hospital, 47000 Sungai Buloh, Selangor Malaysia</aff><aff id="Aff2"><label>2</label><institution-wrap><institution-id institution-id-type="GRID">grid.412259.9</institution-id><institution-id institution-id-type="ISNI">0000 0001 2161 1343</institution-id><institution>Department of Primary Care Medicine, Faculty of Medicine,</institution><institution>Universiti Teknologi MARA,</institution></institution-wrap>Selayang Campus, 68100 Batu Caves, Selangor Malaysia</aff><aff id="Aff3"><label>3</label><institution-wrap><institution-id institution-id-type="GRID">grid.412259.9</institution-id><institution-id institution-id-type="ISNI">0000 0001 2161 1343</institution-id><institution>Department of Population Health & Preventive Medicine,</institution><institution>Faculty of Medicine Universiti Teknologi MARA,</institution></institution-wrap>Sungai Buloh Campus, Jalan Hospital, 47000 Sungai Buloh, Selangor Malaysia</aff><aff id="Aff4"><label>4</label><institution-wrap><institution-id institution-id-type="GRID">grid.412259.9</institution-id><institution-id institution-id-type="ISNI">0000 0001 2161 1343</institution-id><institution>Department of Computer Science, Faculty of Computer and Mathematical Sciences,</institution><institution>Universiti Teknologi MARA,</institution></institution-wrap>40450 Shah Alam, Selangor Malaysia</aff><aff id="Aff5"><label>5</label><institution-wrap><institution-id institution-id-type="GRID">grid.412259.9</institution-id><institution-id institution-id-type="ISNI">0000 0001 2161 1343</institution-id><institution>Department of Psychiatry, Faculty of Medicine,</institution><institution>Universiti Teknologi MARA,</institution></institution-wrap>Sungai Buloh, Campus, Jalan Hospital, 47000 Sungai Buloh, Selangor Malaysia</aff></contrib-group><pub-date pub-type="epub"><day>5</day><month>4</month><year>2020</year></pub-date><pub-date pub-type="pmc-release"><day>5</day><month>4</month><year>2020</year></pub-date><pub-date pub-type="collection"><year>2020</year></pub-date><volume>21</volume><elocation-id>311</elocation-id><history><date date-type="received"><day>31</day><month>10</month><year>2019</year></date><date date-type="accepted"><day>9</day><month>3</month><year>2020</year></date></history><permissions><copyright-statement>© The Author(s) 2020</copyright-statement><license license-type="OpenAccess"><license-p><bold>Open Access</bold>This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit <ext-link ext-link-type="uri" xlink:href="http://creativecommons.org/licenses/by/4.0/">http://creativecommons.org/licenses/by/4.0/</ext-link>. The Creative Commons Public Domain Dedication waiver (<ext-link ext-link-type="uri" xlink:href="http://creativecommons.org/publicdomain/zero/1.0/">http://creativecommons.org/publicdomain/zero/1.0/</ext-link>) applies to the data made available in this article, unless otherwise stated in a credit line to the data.</license-p></license></permissions><abstract id="Abs1"><sec><title>Background</title><p id="Par1">Epidemiological studies conducted in various parts of the world have clearly demonstrated that metabolic syndrome (MetS) is an increasing global health problem, not only in Western societies but also in Asian populations. Web-based and mobile phone-based self-management applications have been proven to be effective in improving self-management behaviour of patients with MetS components (i.e., diabetes or hypertension). However, evidence is lacking in terms of their effectiveness specifically for patients with MetS. The aim of this pilot study is to evaluate the feasibility and potential effectiveness of the EMPOWER-SUSTAIN Self-Management e-Health Intervention in improving activation and self-management behaviours among patients with MetS. This paper presents the study protocol.</p></sec><sec><title>Methods</title><p id="Par2">A pilot randomised controlled trial will be conducted in a university primary care clinic. A total of 232 patients aged 18–60 years with MetS will be recruited; 116 will be randomised to receive the EMPOWER-SUSTAIN intervention for 6 months, and another 116 patients will continue with usual care. The EMPOWER-SUSTAIN intervention is a multifaceted chronic disease management strategy based on the Chronic Care Model and persuasive technology theory. It consists of training primary care physicians, nurses and patients to use the EMPOWER-SUSTAIN web-based self-management mobile app, strengthening the patient–physician relationship and reinforcing the use of relevant clinical practice guidelines to guide management and prescribing. The primary outcome is the mean change in patient activation score using the Patient Activation Measure short form Malay version (PAM-13-M) questionnaire. The secondary outcomes include the changes in waist circumference, body mass index, blood pressure, patient physical activity level, eating behaviour, perception of chronic illness care, satisfaction with patient–physician interaction, and perceived absolute 10-year cardiovascular disease risk. Feasibility of implementing the intervention will be evaluated. This includes acceptability of the intervention, estimating the likely rate of participant recruitment and retention, appropriateness of the outcome measures, calculation of sample size, and the intervention’s potential effectiveness.</p></sec><sec><title>Conclusion</title><p id="Par3">To our knowledge, this is the first study in Malaysia that aims to determine the feasibility of a multifaceted e-health intervention, as well as to indicate more useful aspects of this intervention for further exploration in a larger trial.</p></sec><sec><title>Trial registration</title><p id="Par4">ClinicalTrials.gov, <ext-link ext-link-type="uri" xlink:href="https://clinicaltrials.gov/ct2/show/NCT04120779">NCT04120779</ext-link>. Registered on 9 October 2019, protocol version 1.</p></sec></abstract><kwd-group xml:lang="en"><title>Keywords</title><kwd>E-health intervention</kwd><kwd>Self-management</kwd><kwd>Patient activation</kwd><kwd>Chronic Care Model</kwd><kwd>Chronic disease management</kwd><kwd>Multifaceted intervention</kwd><kwd>Metabolic syndrome</kwd><kwd>Primary care</kwd></kwd-group><funding-group><award-group><funding-source><institution>Ministry of Education (MoE), Malaysia: Prototype Research Grant Scheme (PRGS) </institution></funding-source><award-id>PRGS/1/2018/SKK05/UiTM/01/2 or 600-IRMI/PRGS 5/3 (003/2019)</award-id><principal-award-recipient><name><surname>Ramli</surname><given-names>Anis Safura</given-names></name></principal-award-recipient></award-group></funding-group><custom-meta-group><custom-meta><meta-name>issue-copyright-statement</meta-name><meta-value>© The Author(s) 2020</meta-value></custom-meta></custom-meta-group></article-meta></front></pmc></record>Pour manipuler ce document sous Unix (Dilib)
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