NCT01794052

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6,797

participants targeted

Target at P75+ for not_applicable hypertension

Timeline
Completed

Started Dec 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 23, 2013

Completed
26 days until next milestone

First Posted

Study publicly available on registry

February 18, 2013

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

August 8, 2016

Status Verified

August 1, 2016

Enrollment Period

1.7 years

First QC Date

January 23, 2013

Last Update Submit

August 5, 2016

Conditions

HypertensionType 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (2)

  • Change in the proportion of people with hypertension and/or diabetes receiving evidence based clinical management.

    30 months

  • Change in compliance to therapy and follow-up rate among people with hypertension and/or diabetes.

    30 months

Study Arms (1)

DSS enabled health care delivery model

EXPERIMENTAL

Evidence based, DSS enabled, health care delivery model

Other: Evidence based, DSS enabled, health care delivery model

Interventions

Evidence based, DSS enabled, health care delivery modelOTHER

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

DSS enabled health care delivery model

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All consenting adults of age \>30 years attending the Community Health Centre's and Civil Hospital of Solan District of Himachal Pradesh.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHCs and District Hospital of Solan District

Solan, Himachal Pradesh, 173212, India

Location

Related Publications (1)

  • 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.

    PMID: 28003248DERIVED

MeSH Terms

Conditions

HypertensionDiabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Dorairaj Prabhakaran, MD, DM, MSc, FRCP

    Centre for Chronic Disease Control

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Executive Director

Study Record Dates

First Submitted

January 23, 2013

First Posted

February 18, 2013

Study Start

December 1, 2012

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

August 8, 2016

Record last verified: 2016-08

Locations

IN(1)