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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Hypertension

Intervention / Treatment
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* Other: Intervention
* Other: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants aged ≥30 years. Willing to provide written informed consent for the study. 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: Participants aged <30years Unwilling/unable to provide written informed consent for the study Having malignancies or life threatening conditions Currently participating in other clinical trials Those with plans to move residence in the year ahead.

Ages Eligible for Study
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Minimum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intervention<br>Trained NCC together with electronic decision support system | Other: Intervention<br>* A trained nurse care coordinator enabled with a electronic decision support system placed at the CHCs to share the task of management of hypertension.<br>|
| Other: Control<br>No trained NCC and electronic decision support system | Other: Control<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compliance to therapy | Difference in compliance to therapy from baseline to one year between the intervention and control arm | 12 months | 
| Follow up with the physician | Difference in follow up rate from baseline to one year between the intervention and control arm | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypertension, High blood pressure, Task shifting, Decision support system