CTRI Number |
CTRI/2017/09/009710 [Registered on: 11/09/2017] Trial Registered Retrospectively |
Last Modified On: |
11/09/2017 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Preventive Screening |
Study Design |
Cluster Randomized Trial |
Public Title of Study
|
Effectiveness of mobile health (mHealth) intervention programme (mHealth-MS) on Metabolic Syndrome |
Scientific Title of Study
|
Epidemiological study of Metabolic Syndrome in Rural Population of Rajasthan & Effectiveness of mHealth intervention programme (mHealth-MS) on its components: A Randomized Control Trial |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Arvind Kumar |
Designation |
Assistant Professor |
Affiliation |
|
Address |
Dept, of PSM, RUHS College of Medical Sciences, Sector 11, Kumbha marg, Tonk Road, Jaipur
Jaipur RAJASTHAN 302015 India |
Phone |
8559814816 |
Fax |
|
Email |
dranuaiims@yahoo.com |
|
Details of Contact Person Scientific Query
|
Name |
Arvind Kumar |
Designation |
Assistant Professor |
Affiliation |
RUHS |
Address |
dept. of PSM, RUHS College of Medical Sciences, sector 11, Kumbha Marg, Tonk Road Jaipur Rajasthan University of Health Sciences, sector 18, Kumbha Marg, Tonk Road Jaipur Jaipur RAJASTHAN 302033 India |
Phone |
8559814816 |
Fax |
|
Email |
dranuaiims@yahoo.com |
|
Details of Contact Person Public Query
|
Name |
Arvind Kumar |
Designation |
Assistant Professor |
Affiliation |
RUHS |
Address |
dept. of PSM, RUHS College of Medical Sciences, sector 11, Kumbha Marg, Tonk Road Jaipur Rajasthan University Of Health sciences, sector 18, Kumbha Marg, Tonk Road Jaipur Jaipur RAJASTHAN 302033 India |
Phone |
8559814816 |
Fax |
|
Email |
dranuaiims@yahoo.com |
|
Source of Monetary or Material Support
|
Rajasthan University of Health Sciences,RUHS College of Medical Sciences, sector 18, Kumbha Marg, Tonk Phatak Jaipur |
|
Primary Sponsor
|
Name |
Rajasthan University of Health Sciences |
Address |
RUHS College of Medical Sciences, Sector 18, Pratap Nagar, Kumbha Marg, Sanganer,Sector 18, Pratap Nagar, Kumbha Marg, Sanganer, Jaipur |
Type of Sponsor |
Government funding agency |
|
Details of Secondary Sponsor
|
|
Countries of Recruitment
|
India |
Sites of Study
|
No of Sites = 1 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
Dr Arvind Sharma |
RUHS College of Medical Sciences, Jaipur |
dept. of PSM, RUHS College of Medical Sciences, sector 11, Kumbha Marg, Tonk Phatak Jaipur Jaipur RAJASTHAN |
8559814816 8559814816 dranuaiims@yahoo.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
RUHS college of Medical Sciences |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Healthy Human Volunteers |
Healthy, prediabetics, Diabetics, Prehypertensive, Hypertensive, obase |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
mhealth Intervention |
• Unidirectional daily IVRS audio clip will be used to deliver health messages and triggers to promote knowledge, healthy eating, exercise, self-efficacy, and medication adherence. In this study, subjects will receive two IVRS audio clip daily (7 a.m. and 8 p.m.) on their mobile phone for 1 year. IVRS will be delivered by a fully automated system. |
Comparator Agent |
standard care |
•standard care |
|
Inclusion Criteria
|
Age From |
20.00 Year(s) |
Age To |
80.00 Year(s) |
Gender |
Both |
Details |
1. all individual greater than or equal to twenty years of age
2. have metabolic syndrome
3. Has a text message–capable mobile phone
4. Know how to receive IVRS audio messages
5. Speak and read Hindi.
|
|
ExclusionCriteria |
Details |
1. individual below 20 years of age
2. pregnant women
3. overt psychosis,
4. those participants who are not willing or in position to give consent due to any reason
5. Individuals with a previous physician diagnosis of hypertension or diabetes mellitus, who had not reported medication use
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
On-site computer system |
Blinding/Masking
|
Investigator Blinded |
Primary Outcome
|
Outcome |
TimePoints |
1.Disease progression
2. Knowledge about Diabetes, Hypertension, Obesity, Hypercholestromia |
1 year |
|
Secondary Outcome
|
Outcome |
TimePoints |
ï‚§ Quality of Life (EQ-5D questionnaire)
ï‚§ Cost effectiveness of IVRS interventions |
1 year |
|
Target Sample Size
|
Total Sample Size="1000" Sample Size from India="1000"
Final Enrollment numbers achieved (Total)= "1000"
Final Enrollment numbers achieved (India)="1000" |
Phase of Trial
|
N/A |
Date of First Enrollment (India)
|
07/11/2016 |
Date of Study Completion (India) |
20/03/2018 |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
|
Years="1" Months="6" Days="0" |
Recruitment Status of Trial (Global)
|
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
|
Intensive
programs like lifestyle modifications, drug adherence, exercise, etc. through
mobile phone messages to effect significantly reduce or delay the onset of MS. mHealth
refers to the utilization of mobile phones and other personal mobile devices as
a platform for public health or medical interventions. The present study will
be undertaken with the objectives to study the prevalence of MS and to assess
the effect of mHealth-MS intervention programme on its selected components in
rural population of Rajasthan. A community based intervention study including
4000 subjects’ age 20 years & above will be selected using multi stage
cluster sampling method & PRePAre
risk assessment study’s questionnaire was used to study risk factors.
Each cluster would be 100
participants from each primary sampling unit (PSUs) and total no. of required clusters
are 40. In this study comparing [1] standard of care (50% clusters)
with standard of care plus a mobile phone based IVRS intervention [50% clusters]
for 1 year among patients with MS. IVRS audio messages will be delivered health messages
and triggers to promote knowledge, healthy eating, exercise, self-efficacy, and
medication adherence for one year. After the development of tools and strategy
and assessing the success of this intervention (midterm), research cum action
projects will be developed for other regions of the Rajasthan. |