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Clinical Trials/NCT03164317
NCT03164317
Completed
Not Applicable

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

Centre for Chronic Disease Control, India2 sites in 1 country1,872 target enrollmentAugust 20, 2018
ConditionsHypertension

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hypertension
Sponsor
Centre for Chronic Disease Control, India
Enrollment
1872
Locations
2
Primary Endpoint
Difference in the mean systolic blood pressure
Status
Completed
Last Updated
4 years ago

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.

Registry
clinicaltrials.gov
Start Date
August 20, 2018
End Date
March 31, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Centre for Chronic Disease Control, India
Responsible Party
Principal Investigator
Principal Investigator

Dr. Dorairaj Prabhakaran

Executive Director

Centre for Chronic Disease Control, India

Eligibility Criteria

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)

Study Sites (2)

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