Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Empowering Primary Care Providers and Patients to Improve Chronic Disease Outcomes: The EMPOWER Participatory Action Research (EMPOWER - PAR)
Brief Summary: BACKGROUND

Chronic disease management (CDM) presents enormous challenges to the primary care workforce due to the rising epidemic of cardiovascular risk factors. The Chronic Care Model (CCM) was proven effective in improving chronic disease outcomes in developed countries. Evidence that this model works in developing countries is still scarce. Therefore, the aim of this study is to evaluate the effectiveness of the EMPOWER-PAR intervention (multifaceted CDM strategies based on the CCM) in managing type 2 diabetes mellitus (T2DM) and hypertension (HPT), using readily available resources in the Malaysian public primary care setting.

METHODS

This is a pragmatic cluster randomised controlled trial - participatory action research which is currently being conducted in 10 public primary care clinics in Selangor and Kuala Lumpur, Malaysia. Five clinics are randomly selected to provide the EMPOWER-PAR intervention for 1 year, while the other 5 clinics continued with usual care. Each clinic recruits consecutive T2DM and HPT patients who fulfil the inclusion and exclusion criteria over a 2-week period.

The EMPOWER-PAR intervention consists of creating/strengthening a multidisciplinary CDM Team; and training the team to utilise the Global CV Risks Self-Management Booklet to support patient care and reinforcing them to utilise relevant clinical practice guidelines to aid management and prescribing.

For T2DM, primary outcome is the change in the proportion of patients achieving target HbA1c of \<6.5%. For HPT without T2DM, primary outcome is the change in the proportion of patients achieving target blood pressure of \<140/90 mmHg. Secondary outcomes include the proportion of patients achieving targets serum lipid profile, body mass index and waist circumference. Other outcome measures include medication adherence levels, process of care and prescribing patterns. Patients' assessment of their chronic disease care, providers' perception, attitude and perceived barriers in delivering the care and cost-effectiveness of the intervention are also evaluated.

CONCLUSION

Results from this study will provide objective evidence of the effectiveness and cost-effectiveness of a multifaceted intervention based on the CCM in resource constraint public primary care setting. It is hoped that the evidence will instigate the much needed primary care system change in Malaysia.


Options:
A: Arm Label: Intervention; Type: EXPERIMENTAL; Interventions: Other: Mobile Health Care Environment (MHCE) | Arm Label: Control; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: OTHER; Name: Mobile Health Care Environment (MHCE); Assigned to Arm(s): Intervention
B: Arm Label: EMPOWER-PAR Intervention; Type: EXPERIMENTAL; Interventions: Other: EMPOWER-PAR Intervention | Arm Label: Control; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: OTHER; Name: EMPOWER-PAR Intervention; Assigned to Arm(s): EMPOWER-PAR Intervention
C: Arm Label: Telemedicine case management; Type: EXPERIMENTAL; Interventions: Device: Telemedicine Unit (HTU) | Arm Label: Usual care; Type: ACTIVE_COMPARATOR; Interventions: Other: usual care | Intervention Type: DEVICE; Name: Telemedicine Unit (HTU); Assigned to Arm(s): Telemedicine case management | Intervention Type: OTHER; Name: usual care; Assigned to Arm(s): Usual care
D: Arm Label: Telemedicine; Type: EXPERIMENTAL; Interventions: Device: Telemedicine | Arm Label: Usual care; Type: ACTIVE_COMPARATOR; Interventions: Other: Usual care | Intervention Type: DEVICE; Name: Telemedicine; Assigned to Arm(s): Telemedicine | Intervention Type: OTHER; Name: Usual care; Assigned to Arm(s): Usual care

Answer: B