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

This study has been completed.
Sponsor:
Collaborators:
Ministry of Education, Malaysia
Universiti Teknologi MARA, Malaysia
Information provided by (Responsible Party):
Sharmila MKL, Ministry of Health, Malaysia
ClinicalTrials.gov Identifier:
NCT01545401
First received: March 1, 2012
Last updated: July 18, 2014
Last verified: July 2014
  Purpose

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 score, 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.


Condition Intervention Phase
Type 2 Diabetes Mellitus
Hypertension (Without Type 2 Diabetes Mellitus)
Other: EMPOWER-PAR Intervention
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by Ministry of Health, Malaysia:

Primary Outcome Measures:
  • Change in the proportion of patients achieving glycaemic and BP control [ Time Frame: 1 year ] [ Designated as safety issue: No ]

    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:
  • Change in the proportion of patients achieving clinical targets: [ Time Frame: 1 year ] [ Designated as safety issue: No ]

    Change in the proportion of patients achieving target:

    • BP of < 130/80 mmHg (for T2DM patients)
    • Body Mass Index (BMI) < 22.9 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 ] [ Designated as safety issue: No ]

    Other secondary outcome measures include:

    • Change in the Process of Care related to the management of T2DM and HPT
    • Change in the medication adherence score as measured by the 8-item Morisky Medication Adherence Score (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


Enrollment: 1545
Study Start Date: January 2012
Study Completion Date: June 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01545401

Locations
Malaysia
Universiti Teknologi MARA
Batu Caves, Selangor, Malaysia, 68100
Sponsors and Collaborators
Ministry of Health, Malaysia
Ministry of Education, Malaysia
Universiti Teknologi MARA, Malaysia
Investigators
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
  More Information

No publications provided

Responsible Party: Sharmila MKL, Dr, Ministry of Health, Malaysia
ClinicalTrials.gov Identifier: NCT01545401     History of Changes
Other Study ID Numbers: NMRR-11-250-8769
Study First Received: March 1, 2012
Last Updated: July 18, 2014
Health Authority: Malaysia: Ministry of Health
Malaysia: Ministry of Education

Keywords provided by Ministry of Health, Malaysia:
chronic disease management
Chronic Care Model
multifaceted intervention
primary care
type 2 diabetes mellitus
hypertension

Additional relevant MeSH terms:
Chronic Disease
Diabetes Mellitus
Diabetes Mellitus, Type 2
Hypertension
Disease Attributes
Pathologic Processes
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 28, 2014