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)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by Centre for Chronic Disease Control, India
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
ClinicalTrials.gov Identifier:
NCT01794052
First received: January 23, 2013
Last updated: February 15, 2013
Last verified: February 2013
  Purpose

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 Intervention
Hypertension
Type 2 Diabetes Mellitus
Other: Evidence based, DSS enabled, health care delivery model

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: m-Power Heart Project

Resource links provided by NLM:


Further study details as provided by Centre for Chronic Disease Control, India:

Primary Outcome Measures:
  • Change in the proportion of people with hypertension and/or diabetes receiving evidence based clinical management. [ Time Frame: 30 months ] [ Designated as safety issue: No ]
  • Change in compliance to therapy and follow-up rate among people with hypertension and/or diabetes. [ Time Frame: 30 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 40500
Study Start Date: January 2013
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01794052

Contacts
Contact: Dorairaj Prabhakaran, MD, DM (Cardiology), MSc, FRCP 011-43421900 dprabhakaran@ccdcindia.org
Contact: Ajay V S, PhD Scholar 011-43421900 ajay@ccdcindia.org

Locations
India
CHCs and District Hospital of Solan District Recruiting
Solan, Himachal Pradesh, India, 173212
Contact: Ajay V S, PhD Scholar    011-43421900    ajay@ccdcindia.org   
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 (Cardiology), MSc, FRCP Centre for Chronic Disease Control
  More Information

No publications provided

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
Study First Received: January 23, 2013
Last Updated: February 15, 2013
Health Authority: India: Institutional Review Board

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

ClinicalTrials.gov processed this record on August 26, 2014