To Test the Effectiveness of a Trained Nurse Led, M-health Enabled Intervention to Control Blood Pressure in India
NCT ID: NCT03164317
Last Updated: 2021-07-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
1872 participants
INTERVENTIONAL
2018-08-20
2021-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Intervention
Trained NCC together with electronic decision support system
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 trained NCC and electronic decision support system
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
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
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.
30 Years
ALL
No
Sponsors
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All India Institute of Medical Sciences
OTHER
Indian Council of Medical Research
OTHER_GOV
Centre for Chronic Disease Control, India
OTHER
Responsible Party
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Dr. Dorairaj Prabhakaran
Executive Director
Principal Investigators
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Dorairaj Prabhakaran, MD, DM
Role: PRINCIPAL_INVESTIGATOR
Centre for Chronic Disease Control
Locations
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Community Health Centre
Aganampudi, Andhra Pradesh, India
Area Hospital
Anakapalle, 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
Pāderu, Andhra Pradesh, India
Community Health Centre
V Madugula, Andhra Pradesh, India
Community Health Centre
Yelamanchili, Andhra Pradesh, India
Countries
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References
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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.
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.
Other Identifiers
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CCDC-2017-001
Identifier Type: -
Identifier Source: org_study_id
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