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

Sponsor
Centre for Chronic Disease Control, India (Other)
Overall Status
Completed
CT.gov ID
NCT03164317
Collaborator
All India Institute of Medical Sciences, New Delhi (Other), Indian Council of Medical Research (Other)
1,872
Enrollment
12
Locations
2
Arms
31.3
Actual Duration (Months)
156
Patients Per Site
5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Intervention
  • Other: Control
 N/A

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
Actual Enrollment :
1872 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
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
Actual Study Start Date :
Aug 20, 2018
Actual Primary Completion Date :
Mar 26, 2021
Actual Study Completion Date :
Mar 31, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Difference in the mean systolic blood pressure [12 months]

    Difference in the mean systolic blood pressure between the intervention and control arm at the end of the intervention

Secondary Outcome Measures

  1. Compliance to therapy [12 months]

    Difference in compliance to therapy from baseline to one year between the intervention and control arm

  2. Follow up with the physician [12 months]

    Difference in follow up rate from baseline to one year between the intervention and control arm

Eligibility Criteria

Criteria

Ages Eligible for Study:
30 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Community Health Centre Aganampudi Andhra Pradesh India 530046
2 Area Hospital Anakapalli Andhra Pradesh India 531001
3 Community Health Centre Araku Andhra Pradesh India 531151
4 Community Health Centre Bhimili Andhra Pradesh India 531162
5 Community Health Centre Chintapalli Andhra Pradesh India 531111
6 Community Health Centre Chodavaram Andhra Pradesh India 531036
7 Community Health Centre K Kotpadu Andhra Pradesh India 531034
8 Community Health Centre Kotavaratla Andhra Pradesh India 531085
9 Community Health Centre Nakkapalli Andhra Pradesh India 531081
10 Community Health Centre Paderu Andhra Pradesh India 531024
11 Community Health Centre V Madugula Andhra Pradesh India 531027
12 Community Health Centre Yelamanchili Andhra Pradesh India 531055

Sponsors and Collaborators

  • Centre for Chronic Disease Control, India
  • 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Dr. Dorairaj Prabhakaran, Executive Director, Centre for Chronic Disease Control, India
ClinicalTrials.gov Identifier:
NCT03164317
Other Study ID Numbers:
  • CCDC-2017-001
First Posted:
May 23, 2017
Last Update Posted:
Jul 29, 2021
Last Verified:
Jul 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Dr. Dorairaj Prabhakaran, Executive Director, Centre for Chronic Disease Control, India
Hypertension
High blood pressure
Task shifting
Decision support system
Additional relevant MeSH terms:
Hypertension

Study Results

No Results Posted as of Jul 29, 2021