Hypertensionm-Power HeartNCT01794052
To Develop a High Quality Health Care Delivery Model for the Management of Hypertension and Diabetes at CHCs and District Hospitals of Himachal Pradesh.
A study testing Evidence based, DSS enabled, health care delivery model in people with Hypertension and Type 2 Diabetes Mellitus, run by Centre for Chronic Disease Control, India at 1 site in India.
Trial summary
Hypertension and diabetes are major risk factors for cardiovascular diseases. Although these two conditions can be detected much early in life and are amenable to interventions at primary health care level, the health system in India fails to provide adequate interventions at primary health care level which translates… Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Hypertension, Type 2 Diabetes Mellitus
- What is being tested?
- Evidence based, DSS enabled, health care delivery model
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6,797 participants
- Where
- 1 siteIndia
- Study dates
- Dec 2012to Aug 2014
- 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
- All consenting adults of age >30 years attending the Community Health Centre's and Civil Hospital of Solan District of Himachal Pradesh.
Who cannot join
- Person not willing to consent
- <30 years of age
- History of coronary heart disease or stroke
- Pregnant OR trying to become pregnant OR of child-bearing potential and not actively practicing birth control (including natural methods)
- Malignancy or life-threatening diseases
Trial locations and contacts
1 site in 1 country.
India1 site
CHCs and District Hospital of Solan District
Solan, Himachal Pradesh, 173212
About this study
Official title: m-Power Heart Project
Hypertension and diabetes are major risk factors for cardiovascular diseases. Although these two conditions can be detected much early in life and are amenable to interventions at primary health care level, the health system in India fails to provide adequate interventions at primary health care level which translates to huge burden of undiagnosed and uncontrolled hypertension and diabetes in the community. This study aims to design a feasible and sustainable evidence-based, decision support-enabled, health care delivery model for the management of hypertension and diabetes in the primary health care facilities of Himachal Pradesh. The study will be conducted at the 5 Community Health Centers (CHCs) and District Hospital of Solan District, Himachal Pradesh using both qualitative and quantitative methods. The design and development of the model will be carried out in the initial six months followed by piloting the services at the CHCs and District Hospital. The impact of the model on quality of care will be assessed in a pre-post design measuring changes in both clinical and process indicators.
Read the detailed description
This study aims to design a feasible and sustainable evidence-based, decision support-enabled, health care delivery model for the management of hypertension and diabetes in the primary health care facilities of Himachal Pradesh. The study will be conducted at the 5 Community Health Centers (CHCs) and District Hospital of Solan District, Himachal Pradesh using both qualitative and quantitative methods. The design and development of the model will be carried out in the initial six months followed by piloting the services at the CHCs and District Hospital. The impact of the model on quality of care will be assessed in a pre-post design measuring changes in both clinical and process indicators.
- Conditions
- Hypertension, Type 2 Diabetes Mellitus
- Being tested
- Evidence based, DSS enabled, health care delivery model
- Medical subject headings
- Hypertension, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evidence based, DSS enabled, health care delivery modelOther
The study focus on preliminary work before a definitive randomised controlled trial. In this phase, we are developing an intervention for the evidence based management of hypertension and diabetes at primary care setting in India.
The components of the interventions that we are developing are:
- A structured training of the health care staff for identifying people at risk of developing diabetes or hypertension
- Treating patients as per a standard clinical guidelines
- Giving health education to patients on lifestyle changes for better self-care
- Optimizing the care pathways at the health facilities to enable better delivery of the intervention and
- Development and implementation of a smartphone based decision support system (DSS) with inbuilt diagnostic and treatment algorithm
| Study group | Role | What they receive |
|---|---|---|
| DSS enabled health care delivery model | Experimental | Evidence based, DSS enabled, health care delivery model Receives: Other: Evidence based, DSS enabled, health care delivery model |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the proportion of people with hypertension and/or diabetes receiving evidence based clinical management.
Measured: 30 months
Change in compliance to therapy and follow-up rate among people with hypertension and/or diabetes.
Measured: 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2013 (estimated)
- Study startDec 2012
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6,797 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, Public Health Foundation of India
- Responsible party
- Principal investigator, Dr. Dorairaj Prabhakaran, Centre for Chronic Disease Control, India
- Investigators
- Dorairaj Prabhakaran, MD, DM, MSc, FRCP, Principal investigator, Centre for Chronic Disease Control
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01794052
- Sponsor's protocol ID
- CCDC-2013/001
- Other IDs
- CTRI/2013/02/003412
- Acronym
- m-Power Heart
- Status last verified
- Aug 2016
- First submitted
- 23 Jan 2013
- Last updated
- 8 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Ajay VS, Jindal D, Roy A, Venugopal V, Sharma R, Pawar A, Kinra S, Tandon N, Prabhakaran D. Development of a Smartphone-Enabled Hypertension and Diabetes Mellitus Management Package to Facilitate Evidence-Based Care Delivery in Primary Healthcare Facilities in India: The mPower Heart Project. J Am Heart Assoc. 2016 Dec 21;5(12):e004343. doi: 10.1161/JAHA.116.004343.
PubMed 28003248
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- m-Power Heart Project
- ClinicalTrials.gov ID
- NCT01794052
- Acronym / sponsor ID
- m-Power Heart / CCDC-2013/001
- Conditions
- Hypertension, Type 2 Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6,797 participants (actual)
- Lead sponsor
- Centre for Chronic Disease Control, IndiaUniversity, hospital or other
- Collaborators
- All India Institute of Medical Sciences, Public Health Foundation of India
- Study start
- Dec 2012
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 18 Feb 2013 (estimated)
- 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.
Hypertension and diabetes are major risk factors for cardiovascular diseases. Although these two conditions can be detected much early in life and are amenable to interventions at primary health care level, the health system in India fails to provide adequate interventions at primary health care level which translates to huge burden of undiagnosed and uncontrolled hypertension and diabetes in the community. This study aims to design a feasible and sustainable evidence-based, decision support-enabled, health care delivery model for the management of hypertension and diabetes in the primary health care facilities of Himachal Pradesh. The study will be conducted at the 5 Community Health Centers (CHCs) and District Hospital of Solan District, Himachal Pradesh using both qualitative and quantitative methods. The design and development of the model will be carried out in the initial six months followed by piloting the services at the CHCs and District Hospital. The impact of the model on quality of care will be assessed in a pre-post design measuring changes in both clinical and process indicators.
Detailed description
This study aims to design a feasible and sustainable evidence-based, decision support-enabled, health care delivery model for the management of hypertension and diabetes in the primary health care facilities of Himachal Pradesh. The study will be conducted at the 5 Community Health Centers (CHCs) and District Hospital of Solan District, Himachal Pradesh using both qualitative and quantitative methods. The design and development of the model will be carried out in the initial six months followed by piloting the services at the CHCs and District Hospital. The impact of the model on quality of care will be assessed in a pre-post design measuring changes in both clinical and process indicators.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DSS enabled health care delivery model | Experimental | Other: Evidence based, DSS enabled, health care delivery modelEvidence based, DSS enabled, health care delivery model |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All consenting adults of age >30 years attending the Community Health Centre's and Civil Hospital of Solan District of Himachal Pradesh.
Key exclusion criteria (5 listed)
- Person not willing to consent
- <30 years of age
- History of coronary heart disease or stroke
- Pregnant OR trying to become pregnant OR of child-bearing potential and not actively practicing birth control (including natural methods)
- Malignancy or life-threatening diseases
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 |
|---|---|---|
| Evidence based, DSS enabled, health care delivery modelThe study focus on preliminary work before a definitive randomised controlled trial. In this phase, we are developing an intervention for the evidence based management of hypertension and diabetes at primary care setting in India. The components of the interventions that we are developing are: 1. A structured training of the health care staff for identifying people at risk of developing diabetes or hypertension 2. Treating patients as per a standard clinical guidelines 3. Giving health education to patients on lifestyle changes for better self-care 4. Optimizing the care pathways at the health facilities to enable better delivery of the intervention and 5. Development and implementation of a smartphone based decision support system (DSS) with inbuilt diagnostic and treatment algorithm | Other | DSS enabled health care delivery model |
Primary outcome
Change in the proportion of people with hypertension and/or diabetes receiving evidence based clinical management.
Time frame: 30 months
Change in compliance to therapy and follow-up rate among people with hypertension and/or diabetes.
Time frame: 30 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 8 Aug 2016.
- Derived from this study: PubMed 28003248Ajay VS, Jindal D, Roy A, Venugopal V, Sharma R, Pawar A, Kinra S, Tandon N, Prabhakaran D. Development of a Smartphone-Enabled Hypertension and Diabetes Mellitus Management Package to Facilitate Evidence-Based Care Delivery in Primary Healthcare Facilities in India: The mPower Heart Project. J Am Heart Assoc. 2016 Dec 21;5(12):e004343. doi: 10.1161/JAHA.116.004343.
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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, MSc, FRCP principal investigator
Centre for Chronic Disease Control
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Evidence based, DSS enabled, health care delivery model in people with Hypertension and Type 2 Diabetes Mellitus, run by Centre for Chronic Disease Control, India at 1 site 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 1 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 8 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Change in the proportion of people with hypertension and/or diabetes receiving evidence based clinical management. (time frame: 30 months). The study lists 2 primary outcomes in all. 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 NCT01794052, which also lists 1 linked publication.
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 8 Aug 2016.