Metabolic Syndrome Clinical Trial
Official title:
Study Protocol of the EMPOWER-SUSTAIN Project: A Pilot Randomised Controlled Trial of e-Health Intervention to Improve Patient Activation and Self-Management Behaviours Among Individuals With Metabolic Syndrome in Primary Care Setting
A pilot randomised controlled trial will be conducted in UiTM Primary Care Clinic, Selayang Campus, Selangor, Malaysia. A total of 232 patients with Metabolic Syndrome (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 strategies based on the Chronic Care Model (CCM) and persuasive technology theory. It consists of training physicians and patients to use the EMPOWER-SUSTAIN web-based self-management intervention mobile apps, strengthening patient-physician relationship and reinforcing the use of relevant clinical practice guidelines for 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 change in patients' physical activity level, eating behavior, patients' perception on chronic illness care, satisfaction in physician-patient interaction and perceived absolute 10-year cardiovascular disease (CVD) risk.
Status | Not yet recruiting |
Enrollment | 232 |
Est. completion date | December 31, 2022 |
Est. primary completion date | December 31, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | Inclusion Criteria: - diagnosed with MetS according to the JIS definition - have received follow-up care for MetS at the university primary care clinic at least twice in the last one year - have regular access to the internet - perceive that they have basic skills to use the web and smart mobile phone - are able to read and understand written English or Malay Exclusion Criteria: - type 1 diabetes mellitus - receiving renal dialysis - resented with severe hypertension (Systolic BP > 180 mmHg and/or Diastolic BP > 110 mmHg) at recruitment - diagnosed with conditions resulting in secondary hypertension - diagnosed with circulatory disorders requiring referral to secondary care over the last one year and during the course of the study - receiving shared care at primary and secondary care centres for cardiovascular diseases - receiving chemotherapy/ radiotherapy or palliative care - diagnosed with a psychiatric illness such as schizophrenia, bipolar disorder, major depression - diagnosed with cognitive impairment such as dementia - pregnant - enrolled in another intervention study |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Universiti Teknologi Mara | Ministry of Education, Malaysia |
Abd Aziz A, Izyan Farhana Nordin N, Mohd Noor N, Bachok N, Nor Ismalina Isa S. Psychometric properties of the 'Skala Kepuasan Interaksi Perubatan-11' to measure patient satisfaction with physician-patient interaction in Malaysia. Fam Pract. 2014 Apr;31(2):236-44. doi: 10.1093/fampra/cmt062. Epub 2013 Dec 6. — View Citation
Abdul-Razak S, Ramli AS, Badlishah-Sham SF, Haniff J; EMPOWER-PAR Investigators. Validity and reliability of the patient assessment on chronic illness care (PACIC) questionnaire: the Malay version. BMC Fam Pract. 2018 Jul 19;19(1):119. doi: 10.1186/s12875-018-0807-5. — View Citation
Alberti KG, Eckel RH, Grundy SM, Zimmet PZ, Cleeman JI, Donato KA, Fruchart JC, James WP, Loria CM, Smith SC Jr; International Diabetes Federation Task Force on Epidemiology and Prevention; Hational Heart, Lung, and Blood Institute; American Heart Association; World Heart Federation; International Atherosclerosis Society; International Association for the Study of Obesity. Harmonizing the metabolic syndrome: a joint interim statement of the International Diabetes Federation Task Force on Epidemiology and Prevention; National Heart, Lung, and Blood Institute; American Heart Association; World Heart Federation; International Atherosclerosis Society; and International Association for the Study of Obesity. Circulation. 2009 Oct 20;120(16):1640-5. doi: 10.1161/CIRCULATIONAHA.109.192644. Epub 2009 Oct 5. — View Citation
Chan AW, Tetzlaff JM, Gøtzsche PC, Altman DG, Mann H, Berlin JA, Dickersin K, Hróbjartsson A, Schulz KF, Parulekar WR, Krleza-Jeric K, Laupacis A, Moher D. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ. 2013 Jan 8;346:e7586. doi: 10.1136/bmj.e7586. — View Citation
Chu AH, Moy FM. Reliability and validity of the Malay International Physical Activity Questionnaire (IPAQ-M) among a Malay population in Malaysia. Asia Pac J Public Health. 2015 Mar;27(2):NP2381-9. doi: 10.1177/1010539512444120. Epub 2012 May 16. — View Citation
Eldridge SM, Chan CL, Campbell MJ, Bond CM, Hopewell S, Thabane L, Lancaster GA; PAFS consensus group. CONSORT 2010 statement: extension to randomised pilot and feasibility trials. BMJ. 2016 Oct 24;355:i5239. doi: 10.1136/bmj.i5239. — View Citation
Frijling BD, Lobo CM, Keus IM, Jenks KM, Akkermans RP, Hulscher ME, Prins A, van der Wouden JC, Grol RP. Perceptions of cardiovascular risk among patients with hypertension or diabetes. Patient Educ Couns. 2004 Jan;52(1):47-53. — View Citation
Hibbard JH, Mahoney ER, Stockard J, Tusler M. Development and testing of a short form of the patient activation measure. Health Serv Res. 2005 Dec;40(6 Pt 1):1918-30. — View Citation
Solomon M, Wagner SL, Goes J. Effects of a Web-based intervention for adults with chronic conditions on patient activation: online randomized controlled trial. J Med Internet Res. 2012 Feb 21;14(1):e32. doi: 10.2196/jmir.1924. — View Citation
Subramaniam K, Low WY, Chinna K, Chin KF, Krishnaswamy S. Psychometric Properties of the Malay Version of the Dutch Eating Behaviour Questionnaire (DEBQ) in a Sample of Malaysian Adults Attending a Health Care Facility. Malays J Med Sci. 2017 Aug;24(4):64-73. doi: 10.21315/mjms2017.24.4.8. Epub 2017 Aug 18. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The mean change in patient activation score using the Patient Activation Measure short form Malay version (PAM 13-M) questionnaire. | The PAM-13 consists of 13 items measuring patients' self-reported knowledge, skills and confidence for self-management. Each item is scored on a Likert scale of 1-5. The instrument reflects the 4 stages of activation in a progressing difficulty of the items: level 1 (patients believe that their role is important), level 2 (patients have confidence and knowledge to take action), level 3 (taking action) and level 4 (staying on course under stress). According to the scoring guidelines, the raw scores are transformed through natural logarithm to achieve a better expression of the relative distance between the scores. Then, items are transformed to a standardized metric ranging from 0 to 100 (0 = lower activation; 100 = highest activation). The score is calculated by summing up the raw scores and mapping up the sum onto a scale of 0-100. A higher score of PAM-13 indicates a high level of patients activation. | 6 months | |
Secondary | Change in physical activity level using the International Physical Activity Questionnaire short form Malay version (IPAQ-M) | The IPAQ-M short version comprises of 12 items, covering vigorous, moderate, walking, sitting and sleeping activities. Patients are required to report the activities performed during the last seven days and to include only activities that lasted 10 minutes or more per session. IPAQ will be scored according to its scoring protocol. Continuous score will be expressed as Metabolic Equivalent Task (MET)-minutes per week: MET level x minutes of activity/day x days per week. The scores will then be categorised into 'Low', 'Moderate' and 'Vigorous' physical activity level, in accordance to the Malaysian Clinical Practice Guideline on Primary and Secondary Prevention of Cardiovascular Disease 2017. | 6 months | |
Secondary | Change in eating behaviour will be measured by the Dutch Eating Behaviour Questionnaire - Malay version (DEBQ-M) | The DEBQ-M contains 33 items to measure emotional, external, and restrained eating behaviours. Emotional eating is assessed by 13 items, whereas external and restrained eating behaviours are assessed by 10 items each. The questions that assess the three different behaviours appear in random order in the questionnaire and are answered according to the Likert scale with a scoring system identified as follows: 1 = never, 2 = rarely, 3 = sometimes, 4 = often, and 5 = very often. There are three sub-scales in the instrument. For each subscale, the score is added and divided by the number of items in the sub-scale to obtain the average score for emotional, external and restrained eating for a person. | 6 months | |
Secondary | Change in patients' perceptions and experiences of receiving care for chronic conditions will be measured by the Patients Assessment of Chronic Illness Care Malay version (PACIC-M) questionnaire | The PACIC-M questionnaire consists of 20-item patient self-reported instrument to assess the extent to which patients with chronic disease receive care that aligns with the Chronic Care Model. It measures care that is patient-centred, proactive and planned, which includes collaborative goal setting, problem-solving and follow-up support. Each item is scored on a 5-point Likert scale with 1 being 'no' or 'never' and 5 being 'yes' or 'always'. The higher the score, the more aligned is the perceived care to CCM. | 6 months | |
Secondary | Change in patient-physician satisfaction will be measured by the the Skala Kepuasan Interaksi Perubatan (SKIP 11) questionnaire | SKIP-11 is the translated and validated Malay version of the Medical Interview Satisfaction Scale (MISS-21). It consists of 11 questions representing 3 subdomains of physician-patients interaction satisfaction: 'Distress relief', 'Rapport' and 'Interaction Outcome'. All 11 items are scored using a 5-point Likert scale. Each response will be added together to give a total score within the range of 11 (minimum) and 55 (maximum). Total score for each subdomain is also calculated and analysed where the minimum and maximum score is determined by the number of items present in each subdomain. The levels of satisfaction will be determined by the proximity of the score to either the minimum or maximum score for each subdomain. The closer proximity of the score to the maximum score will reflect good satisfaction level and vice versa. | 6 months | |
Secondary | Change in the accuracy of the Perceived Absolute 10-year CVD Risk | The accuracy of the CVD risk perception will be measured by the absolute difference between the perceived absolute10-year CV risk and the actual calculated risk by FRS General CVD risk prediction chart. The absolute difference will be inversely related i.e. the lower is the absolute difference, the more accurate is the patients' CVD risk perception. | 6 months |
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