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

Primary Purpose

Hypertension

Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Intervention
Control
Sponsored by
Centre for Chronic Disease Control, India
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Hypertension focused on measuring Hypertension, High blood pressure, Task shifting, Decision support system

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Community Health Centre
  • Area Hospital
  • Community Health Centre
  • Community Health Centre
  • Community Health Centre
  • Community Health Centre
  • Community Health Centre
  • Community Health Centre
  • Community Health Centre
  • Community Health Centre
  • Community Health Centre
  • Community Health Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

Intervention

Control

Arm Description

Trained NCC together with electronic decision support system

No trained NCC and electronic decision support system

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Compliance to therapy
Difference in compliance to therapy from baseline to one year between the intervention and control arm
Follow up with the physician
Difference in follow up rate from baseline to one year between the intervention and control arm

Full Information

First Posted
May 21, 2017
Last Updated
July 28, 2021
Sponsor
Centre for Chronic Disease Control, India
Collaborators
All India Institute of Medical Sciences, New Delhi, Indian Council of Medical Research
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1. Study Identification

Unique Protocol Identification Number
NCT03164317
Brief Title
To Test the Effectiveness of a Trained Nurse Led, M-health Enabled Intervention to Control Blood Pressure in India
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
August 20, 2018 (Actual)
Primary Completion Date
March 26, 2021 (Actual)
Study Completion Date
March 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre for Chronic Disease Control, India
Collaborators
All India Institute of Medical Sciences, New Delhi, Indian Council of Medical Research

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
Keywords
Hypertension, High blood pressure, Task shifting, Decision support system

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1872 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Active Comparator
Arm Description
Trained NCC together with electronic decision support system
Arm Title
Control
Arm Type
Other
Arm Description
No trained NCC and electronic decision support system
Intervention Type
Other
Intervention Name(s)
Intervention
Intervention Description
A trained nurse care coordinator enabled with a electronic decision support system placed at the CHCs to share the task of management of hypertension.
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
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
Primary Outcome Measure Information:
Title
Difference in the mean systolic blood pressure
Description
Difference in the mean systolic blood pressure between the intervention and control arm at the end of the intervention
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Compliance to therapy
Description
Difference in compliance to therapy from baseline to one year between the intervention and control arm
Time Frame
12 months
Title
Follow up with the physician
Description
Difference in follow up rate from baseline to one year between the intervention and control arm
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dorairaj Prabhakaran, MD, DM
Organizational Affiliation
Centre for Chronic Disease Control
Official's Role
Principal Investigator
Facility Information:
Facility Name
Community Health Centre
City
Aganampudi
State/Province
Andhra Pradesh
ZIP/Postal Code
530046
Country
India
Facility Name
Area Hospital
City
Anakapalli
State/Province
Andhra Pradesh
ZIP/Postal Code
531001
Country
India
Facility Name
Community Health Centre
City
Araku
State/Province
Andhra Pradesh
ZIP/Postal Code
531151
Country
India
Facility Name
Community Health Centre
City
Bhimili
State/Province
Andhra Pradesh
ZIP/Postal Code
531162
Country
India
Facility Name
Community Health Centre
City
Chintapalli
State/Province
Andhra Pradesh
ZIP/Postal Code
531111
Country
India
Facility Name
Community Health Centre
City
Chodavaram
State/Province
Andhra Pradesh
ZIP/Postal Code
531036
Country
India
Facility Name
Community Health Centre
City
K Kotpadu
State/Province
Andhra Pradesh
ZIP/Postal Code
531034
Country
India
Facility Name
Community Health Centre
City
Kotavaratla
State/Province
Andhra Pradesh
ZIP/Postal Code
531085
Country
India
Facility Name
Community Health Centre
City
Nakkapalli
State/Province
Andhra Pradesh
ZIP/Postal Code
531081
Country
India
Facility Name
Community Health Centre
City
Paderu
State/Province
Andhra Pradesh
ZIP/Postal Code
531024
Country
India
Facility Name
Community Health Centre
City
V Madugula
State/Province
Andhra Pradesh
ZIP/Postal Code
531027
Country
India
Facility Name
Community Health Centre
City
Yelamanchili
State/Province
Andhra Pradesh
ZIP/Postal Code
531055
Country
India

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31110103
Citation
Srinivasapura Venkateshmurthy N, Mc Namara K, Koorts H, Mohan S, S Ajay V, Jindal D, Malipeddi BR, Roy A, Tandon N, Prabhakaran D, Worsley T, Maddison R, O'Reilly S. Process evaluation protocol for a cluster randomised trial of a complex, nurse-led intervention to improve hypertension management in India. BMJ Open. 2019 May 19;9(5):e027841. doi: 10.1136/bmjopen-2018-027841.
Results Reference
derived
PubMed Identifier
30086778
Citation
Srinivasapura Venkateshmurthy N, Ajay VS, Mohan S, Jindal D, Anand S, Kondal D, Tandon N, Rao MB, Prabhakaran D. m-Power Heart Project - a nurse care coordinator led, mHealth enabled intervention to improve the management of hypertension in India: study protocol for a cluster randomized trial. Trials. 2018 Aug 7;19(1):429. doi: 10.1186/s13063-018-2813-2.
Results Reference
derived

Learn more about this trial

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

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