CTRI

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CTRI Number

CTRI/2016/02/006641 [Registered on: 15/02/2016] Trial Registered Prospectively

Last Modified On:

15/09/2016

Post Graduate Thesis

Type of Trial

Interventional

Type of Study

Process of Care Changes

Study Design

Cluster Randomized Trial

Public Title of Study

m-WELLCARE: An integrated mHealth system for the prevention and care of chronic diseases

Scientific Title of Study

An integrated mHealth system for the prevention and care of chronic diseases

Trial Acronym

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Prof Dorairaj Prabhakaran
Designation	Professor
Affiliation	Public Health Foundation of India
Address	Public Health Foundation of India(PHFI) 4th Floor, Plot No. 47, Sector 44 NCR Gurgaon HARYANA 122 022 India
Phone	01244781400
Fax	011244722901
Email	dprabhakaran@ccdcindia.org

Details of Contact Person
Scientific Query

Name	Prof Dorairaj Prabhakaran
Designation	Professor
Affiliation	Public Health Foundation of India
Address	Public Health Foundation of India(PHFI) 4th Floor, Plot No. 47, Sector 44 NCR Public Health Foundation of India(PHFI) 4th Floor, Plot No. 47, Sector 44 NCR Gurgaon HARYANA 122 022 India
Phone	01244781400
Fax	011244722901
Email	dprabhakaran@ccdcindia.org

Details of Contact Person
Public Query

Name	Dr Dev Jindal
Designation	Project Manager
Affiliation	Public Health Foundation of India
Address	Public Health Foundation of India(PHFI) 4th Floor, Plot No. 47, Sector 44 NCR Gurgaon HARYANA 122 022 India
Phone	09899555214
Fax	011244722901
Email	djindal@ccdcindia.org

Source of Monetary or Material Support

Wellcome Trust Gibbs Building 215 Euston Road London NW1 2BE, UK

Primary Sponsor

Name	Wellcome Trust
Address	The Wellcome Trust Gibbs Building 215 Euston Road, London, NW1 2BE, United Kingdom
Type of Sponsor	Other [Global Charitable Foundation]

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 42
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr GAITRI	Aynur CHC	Aynur Shimoga Karnataka 577201 India Shimoga KARNATAKA	9449448755 ncdcliniaynur@gmail.com
Dr JAGADISH PATIL	Holehonnuru CHC	Holehonnuru Shimoga Karnataka 577201 India Shimoga KARNATAKA	9845286586 ncdclinicholehonnur@gmail.com
Dr GBLINGARAJU	Hosanagara Taluk Hospital	Hosanagara Shimoga Karnataka 577201 India Shimoga KARNATAKA	9448566345 ncdclinichosanagar@gmail.com
Dr Bhagya	kunigal General Hospital	kunigal Tumkur Karnataka 572101 India Tumkur KARNATAKA	9449737088 ghkunigal@gmail.com
Dr Gamgadhar	Madhugiri General Hospital	Madhugiri Tumkur Karnataka 572101 India Tumkur KARNATAKA	9449652950 ghmadhugiri@gmail.com
Dr MOHAN K	Shiralkoppa CHC	Shiralkoppa Shimoga Karnataka 577201 India Shimoga KARNATAKA	9481670099 ncdclinicshiralkoppa@gmail.com
Dr Mubarak	Sira General Hospital	Sira Tumkur Karnataka 572101 India Tumkur KARNATAKA	9448250290 gh.sira82@gmail.com
Dr MANJUNATH	Thirthahalli Taluk Hospital	Thirthahalli Shimoga Karnataka 577201 India Shimoga KARNATAKA	9448417043 ncdclinicthirthahalli@gmail.com
Dr Divakar	Turuvekere CHC	Turuvekere Tumkur Karnataka 572101 India Tumkur KARNATAKA	9448294036 amoturuvekere@gmail.com
DR Achuth	Anandapuram CHC	Anandapuram Shimoga Karnataka 577201 India Shimoga KARNATAKA	9448104995 ncdclinicananthpura@gmail.com
Dr Sriharsha Patil	Anavatti CHC	Anavatti Shimoga Karnataka 577201 India Shimoga KARNATAKA	9449968450 mohanavatti@gmail.com
Dr Manish Goel	Assandh SDH	Assandh District Karnal Haryana (India)132001 Karnal HARYANA	8295937120 chcasd1@yahoo.com
Dr Chand Bala	Ballah Community Health Center	Ballah District Karnal Haryana (India)132001 Karnal HARYANA	8295937121 chcballah1@gmail.com
Dr Rajshekar	Bangarpet General Hospital	Bangarpet Kolar Karnataka 563101 India Kolar KARNATAKA	9880093622 chcncdbpet@gmail.com
Dr Amaranath	Bethamangala Community Health Center (CHC)	Bethmangala Bangarpet-Tq Kolar Karnataka 563101 India Kolar KARNATAKA	9632383894 chcncdbtm@gmail.com
Dr SHRIMATHI	Bhadravathi Taluk Hospital	Bhadravathi Shimoga Karnataka 577201 India Shimoga KARNATAKA	9844138920 ncdclinicbhadravathi@gmail.com
Dr Rajinder Saini	Brara Community Health Center	Barara District Ambala Haryana (India)134003 Ambala HARYANA	8295936148 chcbarara2014@gmail.com
Dr Malkeet	Chaurmast-pur Community Health Center	Chaurmastpur District Ambala Haryana (India)134003 Ambala HARYANA	9991872525 chc_cmpuramb@yahoo.com
Dr Manju Lata	Dhakla CHC	Dhakla Distt Jhajjar Haryana India 124507 Jhajjar HARYANA	8295936539 smodhakla@gmail.com
Dr Mahavir Sindhu	Dighal CHC	Dighal Jhajjar Haryana India 124507 Jhajjar HARYANA	8295936540 smodighal@yahoo.in
Dr Kulbeer Singh	Gharaunda Community Health Center	Gharaunda District Karnal Haryana (India)132001 Karnal HARYANA	8295937119 smoghd@gmail.com
Dr Deepak Gupta	Indri Community Health Center	Indri District Karnal Haryana (India)132001 Karnal HARYANA	9996781787 smo.indri@yahoo.co.in
Dr Nafisa	Jhansa Community Health Center	Jhansa Kurukshetra Haryana India 136118 Kurukshetra HARYANA	9416367180 chcjhansa@gmail.com
Dr NARASIMHAMURTHY	Kannangi CHC	Kannangi Shimoga Karnataka 577201 India Shimoga KARNATAKA	9481065540 ncdclinickannangi@gmail.com
Dr Vikas	Ladwa Community Health Center	Ladwa Kurukshetra Haryana India 136118 Kurukshetra HARYANA	9896863463 chcladwa@gmail.com
Dr Shailender Khambra	Mathana Community Health Center	Mathana Kurukshetra Haryana India 136118 Kurukshetra HARYANA	9416254465 chcmathana@gmail.com
Dr Shankar	Mulbagal General Hospital	Mulbagal Kolar Karnataka 563101 India Kolar KARNATAKA	9742965007 chcncdmbl@gmail.com
Dr Kuldeep	Mullana Community Health Center	Ambala Haryana (India)134003 Ambala HARYANA	9416292593 smochcmullana2014@gmail.com
Dr Ashutosh	Mustafabad	Mustafabad Yamuna Nagar Haryana India 135001 Yamunanagar HARYANA	8295832699 smomustafabad@gmail.com
Dr Prashant	Naharpur CHC	Naharpur Yamuna Nagar Haryana India 135001 Yamunanagar HARYANA	9896338880 smochcnpur@gmail.com
Dr Prem Lata	Nilokheri SDH	Nilokheri District Karnal Haryana (India)132001 Karnal HARYANA	8295937118 ghnilokheri@yahoo.in
Dr Rajesh Johri	Nissing Community Health Center	Nissing District Karnal Haryana (India)132001 Karnal HARYANA	9813718636 health.smo.nissing.knl@gmail.com
Dr Rangegowda	Pavagada General Hospital	Pavagada Tumkur Karnataka 572101 India Tumkur KARNATAKA	9449171824 ghamopavagada@gmail.com
Dr Neelam Kakkar	Pehowa Community Health Center	Pehowa Kurukshetra Haryana India 136118 Kurukshetra HARYANA	8295936808 smochcpehowa@gmail.com
Dr Shivinder Singh	Radaur	Radaur Yamuna Nagar Haryana India 135001 Yamunanagar HARYANA	8295936108 smochcrdr@gmail.com
Dr Rajesh Nagar	Sadhaura	Sadhaura Yamuna Nagar Haryana India 135001 Yamunanagar HARYANA	9416470558 Sadhaura.chc@gmail.com
Dr PRAKSH BHOSLE	Sagar Taluk Hospital	Sagar Shimoga Karnataka 577201 India Shimoga KARNATAKA	9591527112 ncdclinicsagar@gmail.com
Dr Ravinder Sharma	Shahbad Community Health Center	Shahbad Shahabad (M) Kurukshetra Haryana India 136118 Kurukshetra HARYANA	9416156050 chcsbd@gmail.com
Dr Tarun Parsad	Shahzadpur Community Health Center	Shahjadpur District Ambala Haryana (India)134003 Ambala HARYANA	9416494520 chcshahzadpur@yahoo.in
Dr Chandrakala	Srinivaspura General Hospital	Srinivaspura Kolar Karnataka 563101 India Kolar KARNATAKA	9945965550 chcncdsvpur@gmail.com
Dr Krishan Kant	Tarori Community Health Center	Tarori District Karnal Haryana (India)132001 Karnal HARYANA	9416294236 chctaraori@yahoo.in
Dr Prahalad	Tiptur General Hospital	Tiptur Tumkur Karnataka 572101 India Tumkur KARNATAKA	9343581353 tipturgh@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Public Health Foundation of India Institutional Ethics Committee	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	Adults aged 30 and above with confirmed diagnosis of hypertension and/or diabetes,

Intervention / Comparator Agent

Type	Name	Details
Intervention	m-Wellcare	Physicians and Nurse Care Coordinators(NCCs) will be trained in use of m-WELLCARE, to help them in confirmation of hypertension/diabetes diagnosis and to continuing care. Physician will use, physician-m-WELLCARE package to guide him/her on the use of confirmatory diagnostic tests (e.g. HbA1c, fasting glucose and repeated blood pressure) before initiating management. Subsequently, m-WELLCARE will link patientâ€™s health profile to produce an individualized management guideline (including lifestyle changes, drug prescriptions and referrals). Patientâ€™s care will then be passed back to the NCC who will provide health education, specific lifestyle advice and monitoring using m-WELLCARE. m-WELLCARE enables regular longitudinal patient monitoring and alerts to the need for changes in management through access to patient health records and automated follow-ups.
Comparator Agent	Usual care arm	Physicians of Community Health Centres (CHCs) and Nurse Care Coordinators will have â€œrefresherâ€ training in the detection, management and follow up of hypertension and/or diabetes using the guidelines and charts provided by the national program and will be provided with a cell phone without m-Wellcare software enabled to facilitate communication with the patient and the clinic. Participants in this arm will receive usual care.

Inclusion Criteria

Age From	30.00 Year(s)
Age To	99.00 Year(s)
Gender	Both
Details	Adults aged 30 yrs and above diagnosed with hypertension and/or diabetes. Has provided written consent (or verbal witnessed consent for illiterate patients).

ExclusionCriteria

Details

1. Patient requiring immediate referral to tertiary care due to accelerated hypertension, diabetic complications.
2. Patients with learning difficulties or vision/ hearing impairments but without a care giver making it impossible to use mobile phone.
3. Pregnant and lactating women

Method of Generating Random Sequence

Not Applicable

Method of Concealment

Not Applicable

Blinding/Masking

Not Applicable

Primary Outcome

Outcome	TimePoints
1. Use of evidence based guidelines 2. Mean predicted 10 year risk of CHD event	12 months

Secondary Outcome

Outcome	TimePoints
1. Systolic blood pressure 2. Fasting blood glucose 3. Glycated hemoglobin 4. Proportion of smokers	12 months

Target Sample Size

Total Sample Size="3600"
Sample Size from India="3600"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)=""

Phase of Trial

Phase 2/ Phase 3

Date of First Enrollment (India)

01/03/2016

Date of Study Completion (India)

Date Missing

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

none yet

Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?

Brief Summary

Major barriers to controlling cardiovascular diseases (CVDs) in India and elsewhere are: low detection rates, inadequate use of evidence based interventions and low adherence with these interventions. Primary health care is the appropriate setting for improving the prevention and management of these chronic conditions. We will develop and evaluate an innovative mobile health (mHealth) software application â€“â€˜m-WELLCAREâ€™- which provides a patient health profile, decision support for clinical care, monitoring and feedback for use in Indian Community Health Centers (CHCs). We will conduct this research following the steps proposed by the medical research council (MRC) for evaluation of complex interventions. Technical development of m-WELLCARE will be conducted, user acceptability appraised and potential barriers overcome. m-WELLCARE will be evaluated in CHCs of two states, Haryana and Karnataka. The use made of m-WELLCARE, its impact on patterns of health care received and changes in risk factors achieved will be evaluated.