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

Not Applicable

Completed

• Conditions: Hypertension
• Interventions: Other: Intervention; Other: Control

• Registration Number: NCT03164317
• Lead Sponsor: Centre for Chronic Disease Control, India

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.

Study Timeline

• Study First Submitted: 2017-05-21
• Study First Submitted QC: 2017-05-22
• Study First Posted: 2017-05-23
• Study Start: 2018-08-20
• Primary Completion: 2021-03-26
• Study Completion: 2021-03-31
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-28
• Last Update Posted: 2021-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1872

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Intervention	Trained NCC together with electronic decision support system
Control	Control	No trained NCC and electronic decision support system

Primary Outcome Measures

Name	Time	Method
Difference in the mean systolic blood pressure	12 months	Difference in the mean systolic blood pressure between the intervention and control arm at the end of the intervention

Secondary Outcome Measures

Name	Time	Method
Compliance to therapy	12 months	Difference in compliance to therapy from baseline to one year between the intervention and control arm
Follow up with the physician	12 months	Difference in follow up rate from baseline to one year between the intervention and control arm

Trial Locations

Locations (2)

Community Health Centre; 🇮🇳 Yelamanchili, Andhra Pradesh, India

Area Hospital; 🇮🇳 Anakapalli, Andhra Pradesh, India