To Develop a High Quality Health Care Delivery Model for the Management of Hypertension and Diabetes at CHCs and District Hospitals of Himachal Pradesh.

Hypertension Clinical Trial

— m-Power Heart  

Official title:

m-Power Heart Project

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01794052
• Other study ID #: CCDC-2013/001
• Secondary ID: CTRI/2013/02/003
• Status: Completed
• Phase: N/A
• First received: January 23, 2013
• Last updated: August 5, 2016
• Start date: December 2012
• Est. completion date: August 2014

Study information

• Verified date: August 2016
• Source: Centre for Chronic Disease Control, India
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6797
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Hypertension
• Type 2 Diabetes Mellitus

Intervention

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: 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

Locations

Country	Name	City	State
India	CHCs and District Hospital of Solan District	Solan	Himachal Pradesh

Sponsors (3)

Lead Sponsor	Collaborator
Centre for Chronic Disease Control, India	All India Institute of Medical Sciences, New Delhi, Public Health Foundation of India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the proportion of people with hypertension and/or diabetes receiving evidence based clinical management.		30 months	No
Primary	Change in compliance to therapy and follow-up rate among people with hypertension and/or diabetes.		30 months	No