Clinical trial NCT03164317: 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
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Keywords: Hypertension
High blood pressure
Task shifting
Decision support system
Lead sponsor: Centre for Chronic Disease Control, India
Sponsor class: OTHER
Collaborators: name: All India Institute of Medical Sciences
name: Indian Council of Medical Research
First posted: 2017-05-23
Enrollment: 1872
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility 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 \<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.

Primary outcomes:
measure: Difference in the mean systolic blood pressure
timeFrame: 12 months
Secondary outcomes:
measure: Compliance to therapy
timeFrame: 12 months
measure: Follow up with the physician
timeFrame: 12 months
Other outcomes:
Locations:
city: Aganampudi
country: India
facility: Community Health Centre
state: Andhra Pradesh
city: Anakapalli
country: India
facility: Area Hospital
state: Andhra Pradesh
city: Araku
country: India
facility: Community Health Centre
state: Andhra Pradesh
city: Bhimili
country: India
facility: Community Health Centre
state: Andhra Pradesh
city: Chintapalli
country: India
facility: Community Health Centre
state: Andhra Pradesh
city: Chodavaram
country: India
facility: Community Health Centre
state: Andhra Pradesh
city: K Kotpadu
country: India
facility: Community Health Centre
state: Andhra Pradesh
city: Kotavaratla
country: India
facility: Community Health Centre
state: Andhra Pradesh
city: Nakkapalli
country: India
facility: Community Health Centre
state: Andhra Pradesh
city: Paderu
country: India
facility: Community Health Centre
state: Andhra Pradesh
city: V Madugula
country: India
facility: Community Health Centre
state: Andhra Pradesh
city: Yelamanchili
country: India
facility: Community Health Centre
state: Andhra Pradesh
Study officials:
affiliation: Centre for Chronic Disease Control
name: Dorairaj Prabhakaran, MD, DM
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.