To Develop a High Quality Health Care Delivery Model for the Management of Hypertension and Diabetes at CHCs and District Hospitals of Himachal Pradesh. (m-Power Heart)

August 5, 2016 updated by: Dr. Dorairaj Prabhakaran, Centre for Chronic Disease Control, India

m-Power Heart Project

Hypertension and diabetes are major risk factors for cardiovascular diseases. Although these two conditions can be detected much early in life and are amenable to interventions at primary health care level, the health system in India fails to provide adequate interventions at primary health care level which translates to huge burden of undiagnosed and uncontrolled hypertension and diabetes in the community. This study aims to design a feasible and sustainable evidence-based, decision support-enabled, health care delivery model for the management of hypertension and diabetes in the primary health care facilities of Himachal Pradesh. The study will be conducted at the 5 Community Health Centers (CHCs) and District Hospital of Solan District, Himachal Pradesh using both qualitative and quantitative methods. The design and development of the model will be carried out in the initial six months followed by piloting the services at the CHCs and District Hospital. The impact of the model on quality of care will be assessed in a pre-post design measuring changes in both clinical and process indicators.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study aims to design a feasible and sustainable evidence-based, decision support-enabled, health care delivery model for the management of hypertension and diabetes in the primary health care facilities of Himachal Pradesh. The study will be conducted at the 5 Community Health Centers (CHCs) and District Hospital of Solan District, Himachal Pradesh using both qualitative and quantitative methods. The design and development of the model will be carried out in the initial six months followed by piloting the services at the CHCs and District Hospital. The impact of the model on quality of care will be assessed in a pre-post design measuring changes in both clinical and process indicators.

Study Type

Interventional

Enrollment (Actual)

6797

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Himachal Pradesh
      • Solan, Himachal Pradesh, India, 173212
        • CHCs and District Hospital of Solan District

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All consenting adults of age >30 years attending the Community Health Centre's and Civil Hospital of Solan District of Himachal Pradesh.

Exclusion Criteria:

  • Person not willing to consent
  • <30 years of age
  • History of coronary heart disease or stroke
  • Pregnant OR trying to become pregnant OR of child-bearing potential and not actively practicing birth control (including natural methods)
  • Malignancy or life-threatening diseases

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: DSS enabled health care delivery model
Evidence based, DSS enabled, health care delivery model
Other: Evidence based, DSS enabled, health care delivery model

The study focus on preliminary work before a definitive randomised controlled trial. In this phase, we are developing an intervention for the evidence based management of hypertension and diabetes at primary care setting in India.

The components of the interventions that we are developing are:

  1. A structured training of the health care staff for identifying people at risk of developing diabetes or hypertension
  2. Treating patients as per a standard clinical guidelines
  3. Giving health education to patients on lifestyle changes for better self-care
  4. Optimizing the care pathways at the health facilities to enable better delivery of the intervention and
  5. Development and implementation of a smartphone based decision support system (DSS) with inbuilt diagnostic and treatment algorithm

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in the proportion of people with hypertension and/or diabetes receiving evidence based clinical management.
Time Frame: 30 months
30 months
Change in compliance to therapy and follow-up rate among people with hypertension and/or diabetes.
Time Frame: 30 months
30 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre for Chronic Disease Control, India

Collaborators

All India Institute of Medical Sciences, New Delhi
Public Health Foundation of India

Investigators

  • Principal Investigator: Dorairaj Prabhakaran, MD, DM, MSc, FRCP, Centre for Chronic Disease Control

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2012

Primary Completion (Actual)

August 1, 2014

Study Completion (Actual)

August 1, 2014

Study Registration Dates

First Submitted

January 23, 2013

First Submitted That Met QC Criteria

February 15, 2013

First Posted (Estimate)

February 18, 2013

Study Record Updates

Last Update Posted (Estimate)

August 8, 2016

Last Update Submitted That Met QC Criteria

August 5, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCDC-2013/001
  • CTRI/2013/02/003412 (Registry Identifier: Clinical Trials Registry India)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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