| CTRI Number |
CTRI/2013/02/003412 [Registered on: 19/02/2013] Trial Registered Retrospectively |
| Last Modified On: |
22/11/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To develop a high quality health care delivery model for the management of hypertension and diabetes at CHCs and District Hospitals of Himachal Pradesh. |
|
Scientific Title of Study
|
m-Power Heart Project |
| Trial Acronym |
m-Power Heart |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CCDC-2013/001 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr D Prabhakaran |
| Designation |
Executive Director |
| Affiliation |
Centre for Chronic Disease Control |
| Address |
Tower No. 4, C9 Commercial Complex, Vasant Kunj
South West
DELHI
110070
India |
| Phone |
011-43421900 |
| Fax |
011-43421975 |
| Email |
dprabhakaran@ccdcindia.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr D Prabhakaran |
| Designation |
Executive Director |
| Affiliation |
Centre for Chronic Disease Control |
| Address |
Tower No. 4, C9 Commercial Complex, Vasant Kunj
South West
DELHI
110070
India |
| Phone |
011-43421900 |
| Fax |
011-43421975 |
| Email |
dprabhakaran@ccdcindia.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr D Prabhakaran |
| Designation |
Executive Director |
| Affiliation |
Centre for Chronic Disease Control |
| Address |
Tower No. 4, C9 Commercial Complex, Vasant Kunj
South West
DELHI
110070
India |
| Phone |
011-43421900 |
| Fax |
011-43421975 |
| Email |
dprabhakaran@ccdcindia.org |
|
|
Source of Monetary or Material Support
|
| PHFI-WTP PhD Research Funds and Medtronic Foundation |
|
|
Primary Sponsor
|
| Name |
Centre for Chronic Disease Control |
| Address |
Tower No. 4, C9 Commercial Complex, Vasant Kunj, New Delhi - 110 070, India |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 6 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Rakshit Sharma |
CHC DARLAGHAT |
Department- Dispensary
Room No-5
Community Health Centre, Darlaghatthe, Tehsil Arki Distt-Solan (H.P)173208
Solan
HIMACHAL PRADESH |
09418147581
sharma0015@gmail.com |
| Rakshit Sharma |
CHC DHARMPUR |
Department- Dispensary
Community Health Centre, Dharmpur, Distt- Solan (H.P)173209
Solan
HIMACHAL PRADESH |
09418147581
sharma0015@gmail.com |
| Rakshit Sharma |
CHC KUNIHAR |
General OPD
Room No- 5, 6
Community Health Centre, Kunihar, Tehsil Arki, Distt Solan (H.P) 173207
Solan
HIMACHAL PRADESH |
9418147581
sharma0015@gmail.com |
| Rakshit Sharma |
CHC SYRI |
Department- Dispensary
Room No-6
Community Health Centre, Syri, Distt- Solan(H.P)173217
Solan
HIMACHAL PRADESH |
09418147581
sharma0015@gmail.com |
| Rakshit Sharma |
FRU NALAGARH |
Department- General Opd
Room No-6
First Referral Unit, Nalagarh, Distt-Solan (H.P) 174101
Solan
HIMACHAL PRADESH |
09418147581
sharma0015@gmail.com |
| Rakshit Sharma |
Regional Hospital |
Department- MD Medicines
Room No-119
Regional Hospital, Solan
Hospital Road, Solan (H.P) 173212
Solan
HIMACHAL PRADESH |
9418147581
sharma0015@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Centre for Chronic Disease Control- Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I10||Essential (primary) hypertension, Hypertension and Type-2 Diabetes Mellitus, (2) ICD-10 Condition: E118||Type 2 diabetes mellitus with unspecified complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Evidence based, DSS enabled, health care delivery model |
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:
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 with inbuilt diagnostic and treatment algorithm.
In the second phase of the study the participants recruited from 6 health facilities over a period of 18 months will receive the above listed study intervention. The follow-up visits for each of the participant will be recorded for twelve months. The participants will also receive SMS/voice call reminders for life-style modification, compliance to drug therapy and follow-up visits. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
All consenting adults of age >30 years attending the Community Health Centre’s and Civil Hospital of Solan District of Himachal Pradesh. |
|
| ExclusionCriteria |
| Details |
a) Person not willing to consent
b) 30 years of age
c) History of coronary heart disease or stroke
d) Pregnant OR trying to become pregnant OR of child-bearing potential and not actively practicing birth control (including natural methods)
e) Malignancy or life-threatening diseases
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
A fully developed, evidence-based, primary health care delivery model for hypertension/Diabetes management in India
2. Fully developed hypertension/diabetes specific decision support systems (DSS) tools for the use of Physicians and non-physician care providers for delivering high quality, evidence based care at primary care settings in India
|
A fully developed, evidence-based, primary health care delivery model for hypertension/Diabetes management in India
2. Fully developed hypertension/diabetes specific decision support systems (DSS) tools for the use of Physicians and non-physician care providers for delivering high quality, evidence based care at primary care settings in India
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="40500"
Sample Size from India="40500"
Final Enrollment numbers achieved (Total)= "22009"
Final Enrollment numbers achieved (India)="22009" |
|
Phase of Trial
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
07/01/2013 |
| Date of Study Completion (India) |
31/08/2014 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="3"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
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). pii: e004343. doi: 10.1161/JAHA.116.004343. PubMed PMID: 28003248. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief 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 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. |