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. 2018 Aug 7;19:429. doi: 10.1186/s13063-018-2813-2
Primary registry and trial identifying number ClinicalTrials.gov
ID: NCT03164317
Date of registration in primary registry 23 May 2017
Secondary identifying numbers None
Source(s) of monetary or material support Indian Council of Medical Research (ICMR), New Delhi, India
Primary sponsor Center for Chronic Disease Control, Gurgaon, India
Secondary sponsor(s) All India Institute of Medical Sciences, New Delhi, India
Contact for public queries Prof. Dorairaj Prabhakaran (dprabhakaran@ccdcindia.org)
Contact for scientific queries Prof. Dorairaj Prabhakaran (dprabhakaran@ccdcindia.org)
Public title Effectiveness of a trained nurse-led, m-health-enabled intervention to control blood pressure in India
Scientific title A Cluster Randomized Controlled Trial of M-health Enabled, Nurse Care Coordinator-Led Intervention to Improve Management of Hypertension in India: m-Power Heart Project
Countries of recruitment India
Health condition(s) or problem(s) studied Hypertension
Intervention(s) A trained nurse care coordinator enabled with an electronic decision support system placed at the CHCs to share the task of management of hypertension
Key inclusion and exclusion criteria 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 < 30 years
2. Unwilling/unable to provide written informed consent for the study
3. Having a malignancy or a life-threatening condition
4. Currently participating in other clinical trials
5. Those with plans to move residence in the year ahead
Study type Interventional
Date of first enrollment 6 April 2017
Target sample size 1872
Recruitment status On-going
Primary outcome(s) Difference in the mean systolic blood pressure between the intervention and control arms at the end of the intervention, i.e., 12 months
Key secondary outcomes Difference in compliance to therapy from baseline to 1 year between the intervention and control arms
Difference in follow-up rate from baseline to 1 year between the intervention and control arms