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 |