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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)

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ClinicalTrials.gov Identifier: NCT01794052
Recruitment Status : Completed
First Posted : February 18, 2013
Last Update Posted : August 8, 2016
Sponsor:
Collaborators:
All India Institute of Medical Sciences, New Delhi
Public Health Foundation of India
Information provided by (Responsible Party):
Dr. Dorairaj Prabhakaran, Centre for Chronic Disease Control, India

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hypertension Type 2 Diabetes Mellitus Other: Evidence based, DSS enabled, health care delivery model Not Applicable

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  (Clinical Trial)
Actual Enrollment : 6797 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: m-Power Heart Project
Study Start Date : December 2012
Actual Primary Completion Date : August 2014
Actual Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



Primary Outcome Measures :
  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 ]


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Ages Eligible for Study:   30 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01794052


Locations
India
CHCs and District Hospital of Solan District
Solan, Himachal Pradesh, India, 173212
Sponsors and Collaborators
Centre for Chronic Disease Control, India
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 automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Dorairaj Prabhakaran, Executive Director, Centre for Chronic Disease Control, India
ClinicalTrials.gov Identifier: NCT01794052     History of Changes
Other Study ID Numbers: CCDC-2013/001
CTRI/2013/02/003412 ( Registry Identifier: Clinical Trials Registry India )
First Posted: February 18, 2013    Key Record Dates
Last Update Posted: August 8, 2016
Last Verified: August 2016

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