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

Centre for Chronic Disease Control, India

Status: Completed

Conditions: Hypertension

Treatments: Other: Control; Other: Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT03164317

CCDC-2017-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,872 patients

Sex: All

Ages: 30+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,872 participants in 2 patient groups

Intervention

Active Comparator group

Description:

Trained NCC together with electronic decision support system

Treatment:

Other: Intervention

Control

Other group

Description:

No trained NCC and electronic decision support system

Treatment:

Other: Control