NCT03164317

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,872

participants targeted

Target at P75+ for not_applicable hypertension

Timeline
Completed

Started Aug 2018

Typical duration for not_applicable hypertension

Geographic Reach
1 country

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 21, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 23, 2017

Completed
1.2 years until next milestone

Study Start

First participant enrolled

August 20, 2018

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 26, 2021

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2021

Completed
Last Updated

July 29, 2021

Status Verified

July 1, 2021

Enrollment Period

2.6 years

First QC Date

May 21, 2017

Last Update Submit

July 28, 2021

Conditions

Hypertension

Keywords

HypertensionHigh blood pressureTask shiftingDecision support system

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Compliance to therapy

    12 months

  • Follow up with the physician

    12 months

Study Arms (2)

Intervention

ACTIVE COMPARATOR

Trained NCC together with electronic decision support system

Other: Intervention

Control

OTHER

No trained NCC and electronic decision support system

Other: Control

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.

Intervention
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

Control

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Community Health Centre

Aganampudi, Andhra Pradesh, 530046, India

Location

Area Hospital

Anakapalle, Andhra Pradesh, 531001, India

Location

Community Health Centre

Araku, Andhra Pradesh, 531151, India

Location

Community Health Centre

Bhimili, Andhra Pradesh, 531162, India

Location

Community Health Centre

Chintapalli, Andhra Pradesh, 531111, India

Location

Community Health Centre

Chodavaram, Andhra Pradesh, 531036, India

Location

Community Health Centre

K Kotpadu, Andhra Pradesh, 531034, India

Location

Community Health Centre

Kotavaratla, Andhra Pradesh, 531085, India

Location

Community Health Centre

Nakkapalli, Andhra Pradesh, 531081, India

Location

Community Health Centre

Pāderu, Andhra Pradesh, 531024, India

Location

Community Health Centre

V Madugula, Andhra Pradesh, 531027, India

Location

Community Health Centre

Yelamanchili, Andhra Pradesh, 531055, India

Location

Related Publications (2)

  • Srinivasapura Venkateshmurthy N, Mc Namara K, Koorts H, Mohan S, S Ajay V, Jindal D, Malipeddi BR, Roy A, Tandon N, Prabhakaran D, Worsley T, Maddison R, O'Reilly S. Process evaluation protocol for a cluster randomised trial of a complex, nurse-led intervention to improve hypertension management in India. BMJ Open. 2019 May 19;9(5):e027841. doi: 10.1136/bmjopen-2018-027841.

    PMID: 31110103DERIVED

  • Srinivasapura Venkateshmurthy N, Ajay VS, Mohan S, Jindal D, Anand S, Kondal D, Tandon N, Rao MB, Prabhakaran D. m-Power Heart Project - a nurse care coordinator led, mHealth enabled intervention to improve the management of hypertension in India: study protocol for a cluster randomized trial. Trials. 2018 Aug 7;19(1):429. doi: 10.1186/s13063-018-2813-2.

    PMID: 30086778DERIVED

MeSH Terms

Conditions

Hypertension

Interventions

Methods

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Dorairaj Prabhakaran, MD, DM

    Centre for Chronic Disease Control

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Executive Director

Study Record Dates

First Submitted

May 21, 2017

First Posted

May 23, 2017

Study Start

August 20, 2018

Primary Completion

March 26, 2021

Study Completion

March 31, 2021

Last Updated

July 29, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations

IN(12)