NCT04120779

Study Protocol of the EMPOWER-SUSTAIN Project

Status unknown NA Last updated 23 November 2020

What this trial tests

NA trial testing The EMPOWER-SUSTAIN e-Health Self-Management Intervention in Metabolic Syndrome in 232 participants. Status unknown.

Timeline

1 March 2021

Primary endpoint
31 December 2021

31 December 2022

Quick facts

Lead sponsor	Universiti Teknologi Mara
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	232
Start date	1 March 2021
Primary completion	31 December 2021
Estimated completion	31 December 2022

Drugs / interventions tested

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

Conditions studied

• Metabolic Syndrome — all drugs for Metabolic Syndrome →

Sponsor

Universiti Teknologi Mara

Who can join

Adults 18 to 60, any sex, with Metabolic Syndrome. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. 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.
   Daud MH, Ramli AS, Abdul-Razak S, Isa MR, et al · · 2020 · cited 12× · PMID 32248825 · DOI 10.1186/s13063-020-04237-x