Study Protocol of the EMPOWER-SUSTAIN Project

NCT04120779 | Unknown

• 1 other identifier: EMPOWER-SUSTAIN Project
• Study Type: interventional
• Target: 232
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Metabolic Syndrome

Keywords

e-health intervention; self-management; primary care; chronic care model

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Change in physical activity level using the International Physical Activity Questionnaire short form Malay version (IPAQ-M)

  6 months

• Change in eating behaviour will be measured by the Dutch Eating Behaviour Questionnaire - Malay version (DEBQ-M)

  6 months

• 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

  6 months

• Change in patient-physician satisfaction will be measured by the the Skala Kepuasan Interaksi Perubatan (SKIP 11) questionnaire

  6 months

• Change in the accuracy of the Perceived Absolute 10-year CVD Risk

  6 months

Study Arms (2)

The EMPOWER-SUSTAIN e-Health Intervention

EXPERIMENTAL

The EMPOWER-SUSTAIN intervention is a multifaceted chronic disease management strategies based on the Chronic Care Model (CCM) and persuasive technology (PT) 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.

Device: The EMPOWER-SUSTAIN e-Health Self-Management Intervention

Control

NO INTERVENTION

The control group will continue to receive usual care at the university primary care clinic. They will be given the EMPOWER-SUSTAIN Global CV Risks Self-Management Booklet©, as this is considered as usual care at the university primary care clinic. The EMPOWER-SUSTAIN web-based self-management tool will be made available to the control group at the end of the study. During the course of the study, there will be no limit to the number of clinic visits that a patient is allowed to make in either the intervention or control groups.

Interventions

The EMPOWER-SUSTAIN e-Health Self-Management Intervention DEVICE

Multifaceted chronic disease management strategies involving web-based self-management intervention mobile apps based on chronic care model and persuasive technology theory to improve patient activation and self-management behaviours among patients with metabolic syndrome.

The EMPOWER-SUSTAIN e-Health Intervention

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universiti Teknologi Mara: lead
• Ministry of Education, Malaysia: collaborator

Related Publications (12)

• Chan AW, Tetzlaff JM, Gotzsche PC, Altman DG, Mann H, Berlin JA, Dickersin K, Hrobjartsson 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.

  PMID: 23303884 BACKGROUND

• 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.

  PMID: 27777223 BACKGROUND

• 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.

  PMID: 19805654 BACKGROUND

• 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. doi: 10.1111/j.1475-6773.2005.00438.x.

  PMID: 16336556 BACKGROUND

• 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.

  PMID: 22593217 BACKGROUND

• 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.

  PMID: 28951691 BACKGROUND

• 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.

  PMID: 30025525 BACKGROUND

• 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.

  PMID: 24317538 BACKGROUND

• 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. doi: 10.1016/s0738-3991(02)00248-3.

  PMID: 14729290 BACKGROUND

• 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.

  PMID: 22353433 BACKGROUND

• Palmer MJ, Machiyama K, Woodd S, Gubijev A, Barnard S, Russell S, Perel P, Free C. Mobile phone-based interventions for improving adherence to medication prescribed for the primary prevention of cardiovascular disease in adults. Cochrane Database Syst Rev. 2021 Mar 26;3(3):CD012675. doi: 10.1002/14651858.CD012675.pub3.

  PMID: 33769555 DERIVED

• Daud MH, Ramli AS, Abdul-Razak S, Isa MR, Yusoff FH, Baharudin N, Mohamed-Yassin MS, Badlishah-Sham SF, Nikmat AW, Jamil N, Mohd-Nawawi H. 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. Trials. 2020 Apr 5;21(1):311. doi: 10.1186/s13063-020-04237-x.

  PMID: 32248825 DERIVED

MeSH Terms

Conditions

Metabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Anis S Ramli, Prof. Dr.

  Institute of Pathology, Laboratory and Forensic Medicine (I-PPerForM)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anis S Ramli, Prof. Dr.

CONTACT

+60193844503; rossanis_yuzadi@yahoo.co.uk

Maryam H Daud

CONTACT

+601139916086; maryamhannahdaud@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Pilot Randomised Controlled Trial

Study Record Dates

• First Submitted: October 4, 2019
• First Posted: October 9, 2019
• Study Start: March 1, 2021
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2022
• Last Updated: November 23, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share