Empowering Primary Care Providers and Patients to Improve Chronic Disease Outcomes: The EMPOWER Participatory Action Research (EMPOWER - PAR)
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|ClinicalTrials.gov Identifier: NCT01545401|
Recruitment Status : Completed
First Posted : March 6, 2012
Last Update Posted : September 19, 2014
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.
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.
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.
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes Mellitus Hypertension (Without Type 2 Diabetes Mellitus)||Other: EMPOWER-PAR Intervention||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1545 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Empowering Primary Care Providers and Patients to Improve Chronic Disease Outcomes: The EMPOWER Participatory Action Research (EMPOWER - PAR)|
|Study Start Date :||January 2012|
|Actual Primary Completion Date :||June 2014|
|Actual Study Completion Date :||June 2014|
Experimental: EMPOWER-PAR Intervention
The intervention arm receives the EMPOWER-PAR intervention package consisting of:
Other: EMPOWER-PAR Intervention
Implementation process is conducted in 3 phases:
I. Phase 1: Formation and training of the CDM team
II. Phase 2: Distributions of the intervention tools
III. Phase 3: Facilitation and support to implement the intervention
No Intervention: Control
The control arm continues with usual care.
The EMPOWER-PAR intervention package will be made available after the trial ends.
- Change in the proportion of patients achieving glycaemic and BP control [ Time Frame: 1 year ]
Outcome measures are obtained from both intervention and control clinics at baseline and at 1-year after the commencement of intervention.
For T2DM patients, primary outcome is measured by the change in the proportion of patients achieving glycaemic target of HbA1c < 6.5%.
For HPT patients without T2DM, primary outcome is measured by the change in the proportion of patients achieving BP target of < 140/90 mmHg.
- Change in the proportion of patients achieving clinical targets: [ Time Frame: 1 year ]
Change in the proportion of patients achieving target:
- BP of ≤ 130/80 mmHg (for T2DM patients)
- Body Mass Index (BMI) < 23 kg/m2
- Waist Circumference (WC) < 90 cm (men), < 80 cm (women)
- Total cholesterol [TC] ≤ 4.5 mmol/L
- Triglycerides [TG] ≤ 1.7 mmol/L
- Low density lipoprotein [LDL-C] ≤ 2.6 mmol/L
- High density lipoprotein [HDL-C] ≥ 1.1 mmol/L
- Other secondary outcome measures [ Time Frame: 1 year ]
Other secondary outcome measures include:
- Change in the Process of Care related to the management of T2DM and HPT
- Change in the medication adherence level as measured by the 8-item Morisky Medication Adherence Scale (MMAS-8)
- Change in the prescribing patterns of antihypertensive agents, oral hypoglycaemic agents, insulin usage and lipid lowering agents
- Patients' perception and experience in receiving care for chronic conditions as measured by the Patients Assessment of Chronic Illness Care (PACIC) score
- Health care providers' perception, attitude, experience and perceived barriers in implementing the EMPOWER-PAR intervention as measured by qualitative analysis
- Cost-effectiveness of the EMPOWER-PAR intervention
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01545401
|Universiti Teknologi MARA|
|Batu Caves, Selangor, Malaysia, 68100|
|Principal Investigator:||Assoc. Prof. Dr. Anis Safura Ramli, MRCGP (UK)||University Teknologi MARA, Malaysia|
|Principal Investigator:||Dr. Jamaiyah Haniff, MPH||Clinical Research Centre|
|Study Director:||Dr. Sharmila Lakshmanan, MBBS||Clinical Research Centre|