To Develop a High Quality Health Care Delivery Model for the Management of Hypertension and Diabetes at CHCs and District Hospitals of Himachal Pradesh.

Overview

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.

Full Title of Study: “m-Power Heart Project”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Health Services Research
    • Masking: None (Open Label)
  • Study Primary Completion Date: August 2014

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.

Interventions

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

Arms, Groups and Cohorts

  • Experimental: DSS enabled health care delivery model
    • Evidence based, DSS enabled, health care delivery model

Clinical Trial Outcome Measures

Primary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 30 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Centre for Chronic Disease Control, India
  • Collaborator
    • All India Institute of Medical Sciences, New Delhi
  • Provider of Information About this Clinical Study
    • Principal Investigator: Dr. Dorairaj Prabhakaran, Executive Director – Centre for Chronic Disease Control, India
  • Overall Official(s)
    • Dorairaj Prabhakaran, MD, DM, MSc, FRCP, Principal Investigator, Centre for Chronic Disease Control

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