Skip to content

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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03164317
Enrollment
1872
Registered
2017-05-23
Start date
2018-08-20
Completion date
2021-03-31
Last updated
2021-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Keywords

Hypertension, High blood pressure, Task shifting, Decision support system

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.

Interventions

OTHERIntervention

A trained nurse care coordinator enabled with a electronic decision support system placed at the CHCs to share the task of management of hypertension.

OTHERControl

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

Sponsors

All India Institute of Medical Sciences
CollaboratorOTHER
Indian Council of Medical Research
CollaboratorOTHER_GOV
Centre for Chronic Disease Control, India
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Difference in the mean systolic blood pressure12 monthsDifference in the mean systolic blood pressure between the intervention and control arm at the end of the intervention

Secondary

MeasureTime frameDescription
Compliance to therapy12 monthsDifference in compliance to therapy from baseline to one year between the intervention and control arm
Follow up with the physician12 monthsDifference in follow up rate from baseline to one year between the intervention and control arm

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 23, 2026