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NCT Number: NCT01794052

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

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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Type 2 Diabetes Mellitus Vascular Diseases

Age range

30 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHCs and District Hospital of Solan District

Solan, Himachal Pradesh, 173212, India

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Evidence based, DSS enabled, health care delivery model

Other

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

Primary outcomes

  1. Change in the proportion of people with hypertension and/or diabetes receiving evidence based clinical management.

    Time frame: 30 months

  2. Change in compliance to therapy and follow-up rate among people with hypertension and/or diabetes.

    Time frame: 30 months

Sponsors and collaborators

Lead sponsor

Centre for Chronic Disease Control, India

Other

Collaborators

  • All India Institute of Medical Sciences
  • Public Health Foundation of India

Registry information

Official study title

m-Power Heart Project

Acronym: m-Power Heart

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Feb 18, 2013
Registry last updated
Aug 8, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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