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

January 23, 2013
February 15, 2013
January 2013
January 2016   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01794052 on ClinicalTrials.gov Archive Site
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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 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.

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Interventional
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Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
  • Hypertension
  • Type 2 Diabetes Mellitus
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
Experimental: Evidence based, DSS enabled, health care delivery model
Intervention: Other: Evidence based, DSS enabled, health care delivery model
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40500
January 2016
January 2016   (final data collection date for primary outcome measure)

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
Both
30 Years and older
No
Contact: Dorairaj Prabhakaran, MD, DM (Cardiology), MSc, FRCP 011-43421900 dprabhakaran@ccdcindia.org
Contact: Ajay V S, PhD Scholar 011-43421900 ajay@ccdcindia.org
India
 
NCT01794052
CCDC-2013/001
No
Dr. Dorairaj Prabhakaran, Centre for Chronic Disease Control, India
Centre for Chronic Disease Control, India
  • All India Institute of Medical Sciences, New Delhi
  • Public Health Foundation of India
Principal Investigator: Dorairaj Prabhakaran, MD, DM (Cardiology), MSc, FRCP Centre for Chronic Disease Control
Centre for Chronic Disease Control, India
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP