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Study Protocol of the EMPOWER-SUSTAIN Project

NCT04120779 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 232

Last updated 2020-11-23

No results posted yet for this study

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

Interventions

DEVICE

The EMPOWER-SUSTAIN e-Health Self-Management Intervention

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.

Sponsors & Collaborators

  • Ministry of Education, Malaysia

    collaborator OTHER_GOV

  • Universiti Teknologi Mara

    lead OTHER

Principal Investigators

  • Anis S Ramli, Prof. Dr. · Institute of Pathology, Laboratory and Forensic Medicine (I-PPerForM)

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-01
Primary Completion
2021-12-31
Completion
2022-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04120779 on ClinicalTrials.gov