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

13 Mar 2017

The date of last modification

Mar 13, 2017



Application Summary


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 of 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 Trail Number

None


Any other number(s) assigned to the trial and issuing authority

CTRI/2016/11/007465 (Clinical Trials Registry - India)


Trial Details


What is the research question being addressed?

  1. What is the feasibility of peer-mentored interventions at worksites to improve CVD health?
  2. What are the most acceptable peer mentor-based interventions for workers to improve CVD health

Type of study

Interventional


Study design

Allocation

Single arm study


Masking

Masking not used


Control

Uncontrolled


Assignment


Purpose

Supportive care


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

  1. Male and female employees above the age of 35yrs
  2. Permanent employment
  3. At least 6 months to retirement

Exclusion criteria

  1. Pregnant or intent to get pregnant in one year.
  2. Inability to attend follow up visits
  3. Any active malignancy or known malignancy on treatment
  4. Will be relocated during the study period
  5. Unwilling or unable to comply with study procedures

(Subject ineligible if even one criterion is met)



Primary outcome(s)

  1. Change in knowledge attitudes & practices related to cardiovascular (CV) risk factors

  2. Identification of barriers and facilitators for an optimal cardiovascular disease (CVD) environment at the worksites

  3. Feasibility and acceptability of the interventions to reduce CV risk.

The above outcomes will be assessed using Face to face interviews, questionnaires and participant diaries.

  1. Cardiovascular (CV) risk burden using a non lab based risk scoring system (Framingham Risk Score)

Primary outcome(s) - Time of assessment(s)

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

  1. Identify & train Peer Mentors to deliver an educational intervention at work sites (outcome will be measured at the end of the training programme)

  2. Change in blood pressure among identified hypertensives (The study is not powered to detect this change at 3 months.)


Secondary outcome(s) - Time of assessment(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)

  2. Change in blood pressure among identified hypertensives (The study is not powered to detect this change at 3 months.)



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


Recruitment status

Pending


State of ethics review approval

Approved by the Ethics Review Committee of the Faculty of Medicine, University of Colombo on 18th December 2015, extended on 24th January 2017 (Ref: EC-15-180)


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



Contact & Sponsor Information


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