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

Centre for Chronic Disease Control, India1,872 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

1,872

Conditions

Hypertension

Interventions

InterventionOTHER

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

ControlOTHER

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

Eligibility

Sex: ALLMin age: 30 Years

Medical Language ↔ Plain English

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.

Locations (12)

Community Health Centre

Aganampudi, Andhra Pradesh, India

Area Hospital

Anakapalle, Andhra Pradesh, India

Community Health Centre

Araku, Andhra Pradesh, India

Outcomes

Primary Outcomes

Difference in the mean systolic blood pressure

Difference in the mean systolic blood pressure between the intervention and control arm at the end of the intervention

Time frame: 12 months

Secondary Outcomes

Compliance to therapy

Difference in compliance to therapy from baseline to one year between the intervention and control arm

Time frame: 12 months

Follow up with the physician

Difference in follow up rate from baseline to one year between the intervention and control arm

Time frame: 12 months

Data from ClinicalTrials.gov

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