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NCT03164317 Clinical Trial

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

Hypertension Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03164317
Other study ID # CCDC-2017-001
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 20, 2018
Est. completion date March 31, 2021

Study information
Verified date July 2021
Source Centre for Chronic Disease Control, India
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 1872
Est. completion date March 31, 2021
Est. primary completion date March 26, 2021
Accepts healthy volunteers No
Gender All
Age group 30 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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.
• 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

Locations
Country Name City State
India Community Health Centre Aganampudi Andhra Pradesh
India Area Hospital Anakapalli Andhra Pradesh
India Community Health Centre Araku Andhra Pradesh
India Community Health Centre Bhimili Andhra Pradesh
India Community Health Centre Chintapalli Andhra Pradesh
India Community Health Centre Chodavaram Andhra Pradesh
India Community Health Centre K Kotpadu Andhra Pradesh
India Community Health Centre Kotavaratla Andhra Pradesh
India Community Health Centre Nakkapalli Andhra Pradesh
India Community Health Centre Paderu Andhra Pradesh
India Community Health Centre V Madugula Andhra Pradesh
India Community Health Centre Yelamanchili Andhra Pradesh

Sponsors (3)
Lead Sponsor Collaborator
Centre for Chronic Disease Control, India All India Institute of Medical Sciences, New Delhi, Indian Council of Medical Research

Country where clinical trial is conducted

India, 

Outcome
Type Measure Description Time frame Safety issue
Primary Difference in the mean systolic blood pressure Difference in the mean systolic blood pressure between the intervention and control arm at the end of the intervention 12 months
Secondary Compliance to therapy Difference in compliance to therapy from baseline to one year between the intervention and control arm 12 months
Secondary Follow up with the physician Difference in follow up rate from baseline to one year between the intervention and control arm 12 months
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