Home » Trials » SLCTR/2017/006
Policy and peer mentor intervention programs on cardiovascular disease at small to medium sized worksites in 3 South Asian countries
-
SLCTR Registration Number
SLCTR/2017/006
Date of Registration
The date of last modification
Mar 03, 2019
Trial Status
Scientific Title of Trial
Policy and peer mentor intervention programs on cardiovascular disease at small to medium sized worksites in 3 South Asian countries
Public Title of Trial
A Research project to reduce the risk of heart attack and strokes at work place.
Disease or Health Condition(s) Studied
Reduce Cardio Vascular Disease risk
Scientific Acronym
PROGRESS (Policy and peeR mentOr intervention proGrams on cardiovasculaR disEase at small to medium sized workSites in 3 South Asian countries)
Public Acronym
PROGRESS (Policy and peeR mentOr intervention proGrams on cardiovasculaR disEase at small to medium sized workSites in 3 South Asian countries)
Brief title
Peer mentor intervention programs on cardio vascular disease at work sites
Universal Trial Number
None
Any other number(s) assigned to the trial and issuing authority
CTRI/2016/11/007465 (Clinical Trials Registry - India)
What is the research question being addressed?
Type of study
Interventional
Study design
Allocation
Single arm study
Masking
Masking not used
Control
Uncontrolled
Assignment
Single
Purpose
Supportive care
Study Phase
Not Applicable
Intervention(s) planned
We will identify 2 work sites in Colombo district and select 10 peer mentors from the each. Every peer mentor will mentor 5 mentees.
Employees above the age of 35 years will be risk stratified into moderate or high risk of developing cardiovascular disease using a simple non-lab based risk scoring system.
Interventions will be delivered as follows; Moderate risk mentees will have two face to face sessions of discussion and high risk mentees will have 3 face to face sessions of discussion. At each session mentees will be provided with advice and guidance on improving medication adherence and healthy life style modifications..
Subject education will focus on lifestyle modification and adherence to medication (If applicable). Importantly the peer mentor will try to identify barriers to adopting a healthy lifestyle (tobacco, physical activity, diet, alcohol and stress) and adherence to Cardio Vascular Disease prevention medications (which are already prescribed by their treating physician).
The peer mentor will be trained to detect and refer (to treating physician or company panel doctor) participants who have a high blood pressure. Peer mentors will be trained to interpret blood glucose and lipids, recognize abnormal values, provide lifestyle counseling and refer to treating physician when appropriate.
Duration of the discussions will be 20 to 30 minutes. First 2 meetings will be held weekly and next follow up meetings will take monthly.
Mentees will be provided with printed diaries which is to be filled by the mentee him/her self, to improve quality of data collection.
Inclusion criteria
Exclusion criteria
(Subject ineligible if even one criterion is met)
Primary outcome(s)
|
1.
Change in knowledge attitudes & practices related to cardiovascular (CV) risk factors - assessed using Face to face interviews, questionnaires and participant diaries. |
[ High risk group: At baseline, at the end of 1 month intervention, and at 2 month and 3 month time points (follow-up) Moderate risk group: At baseline, at the end of 1 month intervention, and at 3 months (follow-up) ] |
|
2.
Identification of barriers and facilitators for an optimal cardiovascular disease (CVD) environment at the worksites - assessed using Face to face interviews, questionnaires and participant diaries. |
[ High risk group: At baseline, at the end of 1 month intervention, and at 2 month and 3 month time points (follow-up) Moderate risk group: At baseline, at the end of 1 month intervention, and at 3 months (follow-up ] |
|
3.
Feasibility and acceptability of the interventions to reduce CV risk - assessed using Face to face interviews, questionnaires and participant diaries. |
[ High risk group: At baseline, at the end of 1 month intervention, and at 2 month and 3 month time points (follow-up) Moderate risk group: At baseline, at the end of 1 month intervention, and at 3 months (follow-up ] |
|
4.
Cardiovascular (CV) risk burden using a non lab based risk scoring system (Framingham Risk Score) |
[ High risk group: At baseline, at the end of 1 month intervention, and at 2 month and 3 month time points (follow-up) Moderate risk group: At baseline, at the end of 1 month intervention, and at 3 months (follow-up ] |
Secondary outcome(s)
|
1.
Identify & train Peer Mentors to deliver an educational intervention at work sites (outcome will be measured at the end of the training programme) |
[ At the end of the 2 day training programme ] |
|
2.
Change in blood pressure among identified hypertensives (The study is not powered to detect this change at 3 months.) |
[ At baseline and at the 3 month follow up point ] |
Target number/sample size
50 to 100 in a work site and select two medium work sites in Sri Lanka.
Countries of recruitment
Sri Lanka
Anticipated start date
2017-03-15
Anticipated end date
2017-12-31
Date of first enrollment
Date of study completion
Recruitment status
Complete: follow up complete
Funding source
1. UK-Medical Research Council (MRC-UK Grant ref. no. MR/M019624/1) 2. Wellcome Trust, UK 3. Department for International Development (DFID), UK
Regulatory approvals
Not applicable
Status
Approved
Date of Approval
2015-12-18
Approval number
EC-15-180 (Last extension 24.01.2017)
Details of Ethics Review Committee
| Name: | Ethics Review Committee, Faculty of Medicine, University of Colombo |
| Institutional Address: | No. 25, Kynsey Road, Colombo 00800 Sri Lanka |
| Telephone: | +94-11-2695300 (Extension: 240) |
| Email: | ethicscommitteemfc@gmail.com |
Contact person for Scientific Queries/Principal Investigator
Dr. Prasad Katulanda
Senior Lecturer in Medicine
Diabetes Research Unit, Department of Clinical Medicine, Faculty of Medicine, University of Colombo, P.O. Box 271, No. 25, Kynsey Road, Colombo 8.
Tel: 0112679204
Mob: 0772920991
Fax: 0112679204
prasad.katulanda@yahoo.com
Contact Person for Public Queries
Dr. Godwin Roger Constantine
Head of the Department
Department of Clinical Medicine, Faculty of Medicine, University of Colombo, P.O. Box 271, No. 25, Kynsey Road, Colombo 8.
Tel: 0112695300
Mob: 0777575683
Fax: 0112691581
grogerconstantine@gmail.com
Primary study sponsor/organization
UK-Medical Research Council (MRC)/ Wellcome Trust/ Department for International Development (DFID)
2nd floor, David Phillips building, Polaris house, North star avenue Swindon, Wiltshire SN2 1FL United Kindom
Tel:+44 1793 416200
http://www.mrc.ac.uk/
Secondary study sponsor (If any)
Dr. Denis Xavier
Professor and Head, Dept. of Pharmacology
St. John’s Medical College, Head – Division of Clinical Research & Training, St. John’s Research Institute, Sarjapur Road, Koramangala,
Bangalore 560034, India
Tel: +91 80 49467005 / +91 80 49466140
Fax: +91 80 49467090
denis@sjri.res.in
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
Not Available
Study protocol available
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
