Clinical trial 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.
Official title: m-Power Heart Project
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Type 2 Diabetes Mellitus
Lead sponsor: Centre for Chronic Disease Control, India
Sponsor class: OTHER
Collaborators: name: All India Institute of Medical Sciences
name: Public Health Foundation of India
First posted: 2013-02-18
Enrollment: 6797
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Change in the proportion of people with hypertension and/or diabetes receiving evidence based clinical management.
timeFrame: 30 months
measure: Change in compliance to therapy and follow-up rate among people with hypertension and/or diabetes.
timeFrame: 30 months
Secondary outcomes:
Other outcomes:
Locations:
city: Solan
country: India
facility: CHCs and District Hospital of Solan District
state: Himachal Pradesh
Study officials:
affiliation: Centre for Chronic Disease Control
name: Dorairaj Prabhakaran, MD, DM, MSc, FRCP
role: PRINCIPAL_INVESTIGATOR
References:
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.