HypertensionNCT03164317
To Test the Effectiveness of a Trained Nurse Led, M-health Enabled Intervention to Control Blood Pressure in India
A study testing Intervention in people with Hypertension, run by Centre for Chronic Disease Control, India at 12 sites in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,872 participants
- Where
- 12 sitesIndia
- Study dates
- 20 Aug 2018to 31 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
India12 sites
Community Health Centre
Aganampudi, Andhra Pradesh, 530046
Area Hospital
Anakapalle, Andhra Pradesh, 531001
Community Health Centre
Araku, Andhra Pradesh, 531151
Community Health Centre
Bhimili, Andhra Pradesh, 531162
Community Health Centre
Chintapalli, Andhra Pradesh, 531111
Community Health Centre
Chodavaram, Andhra Pradesh, 531036
Community Health Centre
K Kotpadu, Andhra Pradesh, 531034
Community Health Centre
Kotavaratla, Andhra Pradesh, 531085
Community Health Centre
Nakkapalli, Andhra Pradesh, 531081
Community Health Centre
Pāderu, Andhra Pradesh, 531024
Community Health Centre
V Madugula, Andhra Pradesh, 531027
Community Health Centre
Yelamanchili, Andhra Pradesh, 531055
About this study
Official 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
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.
- Conditions
- Hypertension
- Being tested
- Intervention, Control
- Keywords
- Hypertension, High blood pressure, Task shifting, Decision support system
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Active comparator | Trained NCC together with electronic decision support system Receives: Other: Intervention |
| Control | Other | No trained NCC and electronic decision support system Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Secondary outcomes (2)
Compliance to therapy
Difference in compliance to therapy from baseline to one year between the intervention and control arm
Measured: 12 months
Follow up with the physician
Difference in follow up rate from baseline to one year between the intervention and control arm
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2017
- Study start20 Aug 2018
- Primary completion26 Mar 2021
- Study completion31 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,872 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre for Chronic Disease Control, India
- Sponsor type
- University, hospital or other
- Collaborators
- All India Institute of Medical Sciences, Indian Council of Medical Research
- Responsible party
- Principal investigator, Dr. Dorairaj Prabhakaran, Centre for Chronic Disease Control, India
- Investigators
- Dorairaj Prabhakaran, MD, DM, Principal investigator, Centre for Chronic Disease Control
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03164317
- Sponsor's protocol ID
- CCDC-2017-001
- Status last verified
- Jul 2021
- First submitted
- 21 May 2017
- Last updated
- 29 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 31110103Srinivasapura 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
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT03164317
- Acronym / sponsor ID
- CCDC-2017-001
- Conditions
- Hypertension
- Keywords
- Hypertension, High blood pressure, Task shifting, Decision support system
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,872 participants (actual)
- Lead sponsor
- Centre for Chronic Disease Control, IndiaUniversity, hospital or other
- Collaborators
- All India Institute of Medical Sciences, Indian Council of Medical Research
- Study start
- 20 Aug 2018 (actual)
- Primary completion
- 26 Mar 2021 (actual)
- Study completion
- 31 Mar 2021 (actual)
- First posted
- 23 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Active comparator | Other: InterventionTrained NCC together with electronic decision support system |
| Control | Other | Other: ControlNo trained NCC and electronic decision support system |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InterventionA trained nurse care coordinator enabled with a electronic decision support system placed at the CHCs to share the task of management of hypertension. | Other | Intervention |
| ControlNo 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 | Other | Control |
Primary outcome
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
2 secondary outcomes
Compliance to therapy
Time frame: 12 months
Follow up with the physician
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2021.
- Derived from this study: PubMed 31110103Srinivasapura 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.
- Derived from this study: PubMed 30086778Srinivasapura 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dorairaj Prabhakaran, MD, DM principal investigator
Centre for Chronic Disease Control
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention in people with Hypertension, run by Centre for Chronic Disease Control, India at 12 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in the mean systolic blood pressure (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03164317, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2021.