A Cluster Randomised Controlled Trial of M-health Enabled, Nurse Care Coordinator Led Intervention to Improve Management of Hypertension in India: m-Power Heart Project
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 1,872
- Locations
- 14
- Primary Endpoint
- Difference in the mean systolic blood pressure
Study Overview
Brief Summary
This study evaluates the effect of a mobile health technology enabled trained nurse led intervention on control of blood pressure among patients with hypertension seeking care in the community health centres in the southern state of Andhra Pradesh, India. half the community health centres will receive the intervention and the other half will receive the routine care.
Detailed Description
The burden of hypertension is very high in India but the control rates of hypertension are very low. One of the important reasons for this is the lack of awareness and the inability of the doctors working in busy out patient settings of public health facilities to care adequately for the patients. Hence there is a need for task shifting.
In this trial a trained nurse care coordinator will be placed in the Community Health Centres (CHCs) and she will be provided with an Electronic Decision Support System (EDSS), in the form of an android application installed on a tablet, to treat hypertension. The trial will be carried out in twelve CHCs of Visakhapatnam district in southern Indian state of Andhra Pradesh.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 30 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Participants aged ≥30 years.
- •Willing to provide written informed consent for the study.
- •Identified as suffering from hypertension (≥160/100 mmHg) with or without co-morbidities such as left ventricular hypertrophy, heart failure, coronary artery disease, peripheral vascular disease, or diabetes mellitus
Exclusion Criteria
- •Participants aged <30years
- •Unwilling/unable to provide written informed consent for the study
- •Having malignancies or life threatening conditions
- •Currently participating in other clinical trials
- •Those with plans to move residence in the year ahead.
Outcomes
Primary Outcomes
Difference in the mean systolic blood pressure
Time Frame: 12 months
Difference in the mean systolic blood pressure between the intervention and control arm at the end of the intervention
Secondary Outcomes
- Compliance to therapy(12 months)
- Follow up with the physician(12 months)
Investigators
Dr. Dorairaj Prabhakaran
Executive Director
Centre for Chronic Disease Control, India