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NCT Number: NCT03164317

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

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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

30 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Community Health Centre, Aganampudi, Andhra Pradesh, India

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Intervention

Other

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

Control

Other

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

Primary outcomes

  1. Difference in the mean systolic blood pressure

    Time frame: 12 months

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

Secondary outcomes

  1. Compliance to therapy

    Time frame: 12 months

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

  2. Follow up with the physician

    Time frame: 12 months

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

Sponsors and collaborators

Lead sponsor

Centre for Chronic Disease Control, India

Other

Collaborators

  • All India Institute of Medical Sciences
  • Indian Council of Medical Research

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
May 23, 2017
Registry last updated
Jul 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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