COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Empowering Primary Care Providers and Patients to Improve Chronic Disease Outcomes: The EMPOWER Participatory Action Research (EMPOWER - PAR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01545401
Recruitment Status : Completed
First Posted : March 6, 2012
Last Update Posted : September 19, 2014
Ministry of Education, Malaysia
Universiti Teknologi Mara
Information provided by (Responsible Party):
Sharmila MKL, Ministry of Health, Malaysia

Brief Summary:


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

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1545 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: EMPOWER-PAR Intervention

The intervention arm receives the EMPOWER-PAR intervention package consisting of:

  1. Chronic Disease Management (CDM) Training Workshops for the staff in the respective clinics
  2. The Global CV Risks Self-Management Booklet (patient self-management tool) to empower patients to self-manage their CV risk factors
  3. Facilitation and support of the staff in these clinics so that they may implement the interventions
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

  • Global CV Risks Self-Management Booklets
  • CPG to aid clinical decision making

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.

Primary Outcome Measures :
  1. 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.

    Primary Outcomes

    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.

Secondary Outcome Measures :
  1. 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

  2. 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion criteria

Males and females aged ≥ 18 years who are diagnosed with:

  1. T2DM or HPT or both
  2. Seen at least once in the last one year at the primary care clinic for the above conditions

Exclusion criteria

  1. Type 1 Diabetes Mellitus
  2. Receiving renal dialysis
  3. Presenting with severe HPT (Systolic BP >180mmHg and/or Diastolic BP >110 mmHg)
  4. Diagnosed with conditions resulting in secondary hypertension
  5. Diagnosed to have circulatory disorders needing referral to secondary care over the last 1 year e.g. unstable angina, heart attack, stroke, transient ischaemic attacks
  6. Receiving shared care between primary and secondary care for complications of T2DM and/or HPT
  7. Pregnancy
  8. Enrolled in another study

All patients in the intervention arm are required to be seen at least twice by the CDM team of each clinic during the 1-year intervention period. Those who do not comply are considered as lost to follow-up. There is no limit to the number of clinic visits a patient is allowed to make in either arm during the course of the study.

Information from the National Library of Medicine

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 identifier (NCT number): NCT01545401

Layout table for location information
Universiti Teknologi MARA
Batu Caves, Selangor, Malaysia, 68100
Sponsors and Collaborators
Ministry of Health, Malaysia
Ministry of Education, Malaysia
Universiti Teknologi Mara
Layout table for investigator information
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
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Sharmila MKL, Dr, Ministry of Health, Malaysia Identifier: NCT01545401    
Other Study ID Numbers: NMRR-11-250-8769
First Posted: March 6, 2012    Key Record Dates
Last Update Posted: September 19, 2014
Last Verified: September 2014
Keywords provided by Sharmila MKL, Ministry of Health, Malaysia:
chronic disease management
Chronic Care Model
multifaceted intervention
primary care
type 2 diabetes mellitus
Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes Mellitus
Diabetes Mellitus, Type 2
Chronic Disease
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Vascular Diseases
Cardiovascular Diseases
Disease Attributes
Pathologic Processes