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)
Primary Purpose
Hypertension, Type 2 Diabetes Mellitus
Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Evidence based, DSS enabled, health care delivery model
Sponsored by
About this trial
This is an interventional health services research trial for Hypertension
Eligibility 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
Sites / Locations
- CHCs and District Hospital of Solan District
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
DSS enabled health care delivery model
Arm Description
Evidence based, DSS enabled, health care delivery model
Outcomes
Primary Outcome Measures
Change in the proportion of people with hypertension and/or diabetes receiving evidence based clinical management.
Change in compliance to therapy and follow-up rate among people with hypertension and/or diabetes.
Secondary Outcome Measures
Full Information
NCT ID
NCT01794052
First Posted
January 23, 2013
Last Updated
August 5, 2016
Sponsor
Centre for Chronic Disease Control, India
Collaborators
All India Institute of Medical Sciences, New Delhi, Public Health Foundation of India
1. Study Identification
Unique Protocol Identification Number
NCT01794052
Brief Title
To Develop a High Quality Health Care Delivery Model for the Management of Hypertension and Diabetes at CHCs and District Hospitals of Himachal Pradesh.
Acronym
m-Power Heart
Official Title
m-Power Heart Project
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
August 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre for Chronic Disease Control, India
Collaborators
All India Institute of Medical Sciences, New Delhi, Public Health Foundation of India
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Type 2 Diabetes Mellitus
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6797 (Actual)
8. Arms, Groups, and Interventions
Arm Title
DSS enabled health care delivery model
Arm Type
Experimental
Arm Description
Evidence based, DSS enabled, health care delivery model
Intervention Type
Other
Intervention Name(s)
Evidence based, DSS enabled, health care delivery model
Intervention Description
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 Outcome Measure Information:
Title
Change in the proportion of people with hypertension and/or diabetes receiving evidence based clinical management.
Time Frame
30 months
Title
Change in compliance to therapy and follow-up rate among people with hypertension and/or diabetes.
Time Frame
30 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dorairaj Prabhakaran, MD, DM, MSc, FRCP
Organizational Affiliation
Centre for Chronic Disease Control
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHCs and District Hospital of Solan District
City
Solan
State/Province
Himachal Pradesh
ZIP/Postal Code
173212
Country
India
12. IPD Sharing Statement
Citations:
PubMed Identifier
28003248
Citation
Ajay VS, Jindal D, Roy A, Venugopal V, Sharma R, Pawar A, Kinra S, Tandon N, Prabhakaran D. Development of a Smartphone-Enabled Hypertension and Diabetes Mellitus Management Package to Facilitate Evidence-Based Care Delivery in Primary Healthcare Facilities in India: The mPower Heart Project. J Am Heart Assoc. 2016 Dec 21;5(12):e004343. doi: 10.1161/JAHA.116.004343.
Results Reference
derived
Learn more about this trial
To Develop a High Quality Health Care Delivery Model for the Management of Hypertension and Diabetes at CHCs and District Hospitals of Himachal Pradesh.
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