To Test the Effectiveness of a Trained Nurse Led, M-health Enabled Intervention to Control Blood Pressure in India

July 28, 2021 updated by: Dr. Dorairaj Prabhakaran, Centre for Chronic Disease Control, India

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

1872

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Andhra Pradesh
      • Aganampudi, Andhra Pradesh, India, 530046
        • Community Health Centre
      • Anakapalli, Andhra Pradesh, India, 531001
        • Area Hospital
      • Araku, Andhra Pradesh, India, 531151
        • Community Health Centre
      • Bhimili, Andhra Pradesh, India, 531162
        • Community Health Centre
      • Chintapalli, Andhra Pradesh, India, 531111
        • Community Health Centre
      • Chodavaram, Andhra Pradesh, India, 531036
        • Community Health Centre
      • K Kotpadu, Andhra Pradesh, India, 531034
        • Community Health Centre
      • Kotavaratla, Andhra Pradesh, India, 531085
        • Community Health Centre
      • Nakkapalli, Andhra Pradesh, India, 531081
        • Community Health Centre
      • Paderu, Andhra Pradesh, India, 531024
        • Community Health Centre
      • V Madugula, Andhra Pradesh, India, 531027
        • Community Health Centre
      • Yelamanchili, Andhra Pradesh, India, 531055
        • Community Health Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Participants aged ≥30 years.
  2. Willing to provide written informed consent for the study.
  3. 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:

  1. Participants aged <30years
  2. Unwilling/unable to provide written informed consent for the study
  3. Having malignancies or life threatening conditions
  4. Currently participating in other clinical trials
  5. Those with plans to move residence in the year ahead.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Intervention
Trained NCC together with electronic decision support system
Other: Intervention
A trained nurse care coordinator enabled with a electronic decision support system placed at the CHCs to share the task of management of hypertension.
Other: Control
No trained NCC and electronic decision support system
Other: Control
No NCC or EDSS will be placed in the CHCs. Doctors working in the CHCs will be given training (one day) on evidence based management of hypertension

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compliance to therapy
Time Frame: 12 months
Difference in compliance to therapy from baseline to one year between the intervention and control arm
12 months
Follow up with the physician
Time Frame: 12 months
Difference in follow up rate from baseline to one year between the intervention and control arm
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre for Chronic Disease Control, India

Collaborators

All India Institute of Medical Sciences, New Delhi
Indian Council of Medical Research

Investigators

  • Principal Investigator: Dorairaj Prabhakaran, MD, DM, Centre for Chronic Disease Control

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 20, 2018

Primary Completion (Actual)

March 26, 2021

Study Completion (Actual)

March 31, 2021

Study Registration Dates

First Submitted

May 21, 2017

First Submitted That Met QC Criteria

May 22, 2017

First Posted (Actual)

May 23, 2017

Study Record Updates

Last Update Posted (Actual)

July 29, 2021

Last Update Submitted That Met QC Criteria

July 28, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCDC-2017-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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