ClinicalTrials.gg
CompletedNCT03164317Updated Jul 29, 2021

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

An interventional study of Intervention and Control in Hypertension, sponsored by Centre for Chronic Disease Control, India. Completed at 12 sites in India. Open to participants aged 30 Years and older. Per ClinicalTrials.gov, last updated 2021-07-29.

Sponsored by Centre for Chronic Disease Control, India · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
1,872
Allocation
Randomized
Ages
30 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Hypertension

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Keywords

  • Hypertension
  • High blood pressure
  • Task shifting
  • Decision support system
03

In context

Hypertension

6,114 studies on the registry are indexed under Hypertension; 912 are open to participants now.

This study's enrollment of 1,872 is above the median of 100 across 4,575 interventional studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

Centre for Chronic Disease Control, India is the lead sponsor of 9 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Participants aged ≥30 years.
  2. Willing to provide written 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

Exclusion Criteria:

  1. Participants aged \<30years
  2. Unwilling/unable to provide written for the study
  3. Having or life threatening conditions
  4. Currently participating in other clinical trials
  5. Those with plans to move residence in the year ahead.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

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Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
1,872 participants (actual)

Study arms

  • Active comparator
    Intervention

    Trained NCC together with electronic decision support system

    Other: Intervention

  • Other
    Control

    No trained NCC and electronic decision support system

    Other: Control

Interventions

  • OtherIntervention

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

  • OtherControl

    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

06

What researchers measure

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

    Time frame: 12 months

Secondary outcomes

  1. Compliance to therapy

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

    Time frame: 12 months

  2. 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

07

Study locations

12 sites
  • Community Health Centre
    Aganampudi, Andhra Pradesh 530046, India
  • Area Hospital
    Anakapalli, Andhra Pradesh 531001, India
  • Community Health Centre
    Araku, Andhra Pradesh 531151, India
  • Community Health Centre
    Bhimili, Andhra Pradesh 531162, India
  • Community Health Centre
    Chintapalli, Andhra Pradesh 531111, India
  • Community Health Centre
    Chodavaram, Andhra Pradesh 531036, India
  • Community Health Centre
    K Kotpadu, Andhra Pradesh 531034, India
  • Community Health Centre
    Kotavaratla, Andhra Pradesh 531085, India
  • Community Health Centre
    Nakkapalli, Andhra Pradesh 531081, India
  • Community Health Centre
    Paderu, Andhra Pradesh 531024, India
  • Community Health Centre
    V Madugula, Andhra Pradesh 531027, India
  • Community Health Centre
    Yelamanchili, Andhra Pradesh 531055, India
08

References and documents

Publications

  • 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. PubMed 31110103 ↗
  • 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. PubMed 30086778 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 29, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03164317
Lead sponsor
Centre for Chronic Disease Control, India
Collaborators
All India Institute of Medical Sciences, New Delhi, Indian Council of Medical Research
Responsible party
Dr. Dorairaj Prabhakaran (Executive Director, Centre for Chronic Disease Control, India) — Principal investigator
First posted
May 23, 2017
Start date
Aug 20, 2018
Primary completion
Mar 26, 2021
Completion
Mar 31, 2021
Last update
Jul 29, 2021

Study contacts

Dorairaj Prabhakaran, MD, DM
principal investigator · Centre for Chronic Disease Control

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.

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