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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by Ministry of Health, Malaysia.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Sharmila MKL, Ministry of Health, Malaysia
ClinicalTrials.gov Identifier:
NCT01545401
First received: March 1, 2012
Last updated: March 5, 2012
Last verified: March 2012
  Purpose

This a Pragmatic Cluster Randomised Participatory Action Research (CRPAR) whereby we will be comparing two groups of clinics (an Intervention group versus a control group). For this reason, we plan to select 5 clinics in the Intervention arm, and 5 clinics in the control arm; and compare the health outcomes in both these groups at the end of the study.

The patients which we intend to study are ones with Type 2 DM and Hypertension, between the ages of 30-70 years, without other complications/comorbidities ( as specified in our protocol methodology). In the intervention arm or Group, the clinics will be given an Intervention package which consists of the following:

  1. Chronic Disease management( CDM) workshops to train the staff ( we hope to develop a CDM group for each clinic)
  2. Facilitation and support for the staff ( CDM Team) to implement changes in their practice
  3. The Global Cardiovascular Risks Self-management Booklet to empower patients to self manage their cardiovascular risk factors

Hence the said Intervention package as above, are actually strategies, to improve or enhance better health outcome in the patients with Type 2 DM and Hypertension, that are seen by our doctors in the primary care setting here in Malaysia.

As for the control group, the patients will be followed up by their primary care staff with the usual care.


Condition Intervention Phase
Hypertension
Type 2 Diabetes Mellitus
Other: EMPOWER-PAR
Phase 4

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 ]
    • Change in the proportion of patients achieving glycaemic control as defined by HbA1c <6.5%
    • Change in proportion of patients achieving blood pressure control as defined by BP <140/90 mmHg for those without diabetes


Secondary Outcome Measures:
  • Target achievement of blood pressure and lipid profile for diabetic patients [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    • Change in the proportion of patients achieving blood pressure control as defined by BP <130/80 mmHg
    • Change in the proportion of patients achieving lipid control as defined by TC < 4.5, TG <1.7 mmol/L, LDL <2.6 mmol/L, HDL >1.1 mmol/L

  • Target achievement of Lipid profile only for hypertensive patients [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    • Change in the proportion of patients achieving lipid control as defined by TC < 5.0, TG <1.7 mmol/L, LDL <3.4 mmol/L, HDL >1.1 mmol/L


Estimated Enrollment: 2320
Study Start Date: April 2012
Estimated Study Completion Date: April 2012
Estimated Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Chronic Disease Management
EMPOWER-PAR package consist of CDM training, delivery and monitoring of patients with diabetes and hypertension
Other: EMPOWER-PAR
Chronic disease management training, delivery and monitoring of patients with diabetes and hypertension.
Other Name: Chronic disease management
No Intervention: Usual Care
No CDM intervention. Usual care only.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   30 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males and females 30-70 years of age diagnosed with Type 2 Diabetes Mellitus (T2DM) and / or Hypertension (HPT) without T2DM, whom have received follow-up care for T2DM/HPT in the same clinic at least twice in the last 1 year

Exclusion Criteria:

  • Type 1 Diabetes Mellitus.
  • Receiving renal dialysis.
  • Presenting with severe hypertension (SBP >180mmHg and/or DBP >110 mmHg).
  • Diagnosed with conditions resulting in secondary hypertension.
  • 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.
  • Receiving shared care between primary and secondary care for complications of T2DM and/or HPT.
  • Pregnancy.
  • Inability to comply with the follow-up requirements.
  • Inability to provide informed consent.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01545401

Contacts
Contact: Dr Sharmila Lakshmanan 0060340443060 ext 206 sharmilamkl@crc.gov.my
Contact: Dr Jamaiyah Haniff 0060340443060 ext 203 jamaiyah@crc.gov.my

Locations
Malaysia
Anis Safura Ramli Not yet recruiting
Kuala Lumpur, Federal Territory, Malaysia, 53000
Contact: Sharmila Lakshmanan, MBBS    006-03-40443060    sharmilamkl@crc.gov.my   
Contact: Jamaiyah Haniff, MBBS    006-03-40443060    jamaiyah@crc.gov.my   
Klinik Kesihatan Setapak Not yet recruiting
Kuala Lumpur, federal Territory, Malaysia, 53200
Sponsors and Collaborators
Ministry of Health, Malaysia
Investigators
Principal Investigator: Anis Safura Ramli, MBBS University Technology MARA, Malaysia
Principal Investigator: Jamaiyah Haniff, MBBS Clinical Research Centre
Principal Investigator: Sharmila Lakshmanan, MBBS Clinical Research Centre
Principal Investigator: Wilson Low Azmi Burhani Consulting Sdn Bhd
Principal Investigator: Sharmini Selvarajah, MBBS Clinical Research Centre
Principal Investigator: Jaya Purany Stanley, MBBS Clinical Research Centre
Principal Investigator: Fatanah Ismail, MBBS Netherlands: Ministry of Health, Welfare and Sports
Principal Investigator: Feisul Idzwan Mustapha, MBBS Netherlands: Ministry of Health, Welfare and Sports
Principal Investigator: Sivasangari Subramaniam Netherlands: Ministry of Health, Welfare and Sports
Principal Investigator: Mastura Ismail, MBBS Netherlands: Ministry of Health, Welfare and Sports
  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: March 5, 2012
Health Authority: Malaysia: Ministry of Health

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 April 17, 2014