Cardiovascular DiseasePROGRESSNCT02388542
Effect of Peer-mentor Mediated Interventions on Cardiovascular Risk Factors at Worksites
A study testing Educational Intervention in people with Cardiovascular Disease, run by St. John's Research Institute at 6 sites in 3 countries.
Trial summary
The investigators propose conducting a pilot study to identify 6 worksites (2 India, 2 Sri Lanka, 2 Bangladesh) explore barriers to optimum cardiovascular disease(CVD) care at these worksites, quantify risk factor level in worksite populations and identify and train peer mentors to deliver an educational intervention… Read more about this study
- Who is it for?
- Ages 35 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Disease
- What is being tested?
- Educational Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 334 participants
- Where
- 6 sitesin 3 countries
- Study dates
- May 2015to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All criteria must be met to be eligible
- Employees (Men \& Women) above the age of 35 years.
- permanent employees with at least 6 months for retirement.
- Willing to provide Informed Consent.
Who cannot join
- Subject ineligible if even one criterion is met
- Pregnant or intent to get pregnant in one year.
- Inability to attend follow up visits.
- Any active malignancy or known malignancy on treatment.
- Will relocate during the study period.
- Unwilling or unable to comply with study procedures.
Trial locations and contacts
6 sites in 3 countries.
6 sites in 3 countries
Bangladesh2 sites
Appollo Ispat Complex Ltd
Dhaka
Shardharan Bima Coorporation
Dhaka
India2 sites
Bharat Heavy Electrical Limited
Bangalore
TVS Motor company Limited
Hosūr
Sri Lanka2 sites
Department of Census & Statistics
Colombo
Sri Lanka Telecom
Colombo
About this study
Official title: Policy and Peer Mentor Intervention Programs on Cardiovascular Disease at Small to Medium Sized Worksites in 3 South Asian Countries - a Pilot Study for a Definitive Large International Cluster Randomized Trial
The investigators propose conducting a pilot study to identify 6 worksites (2 India, 2 Sri Lanka, 2 Bangladesh) explore barriers to optimum cardiovascular disease(CVD) care at these worksites, quantify risk factor level in worksite populations and identify and train peer mentors to deliver an educational intervention to improve life style and enhance medication adherence among those at moderate to high risk of cardiovascular disease (CVD).
Read the detailed description
Eligibility Criteria -
All employees aged above 35 years at selected workplaces.
Study design - Mixed methods methods Phase 1 - Qualitative study; Phase 2 - Quantitative - Single group, non-randomized before-after comparison study + KAP survey
Sample size - Approximately 334 participants.
The study entails the following steps -
Step 1 - An evaluation for knowledge, attitudes and practices (KAP) related to cardiovascular health/ disease at worksites.
Step 2 - A qualitative study for barriers and facilitators of behaviors associated with optimal cardiovascular health
Step 3 - Baseline assessment of cardiovascular risk using a non-lab based risk assessment score
Step 4 - Piloting a trained peer mentored educational/ intensive follow-up intervention for 3 month with a re-assessment at 3 months.
- Conditions
- Cardiovascular Disease
- Being tested
- Educational Intervention
- Keywords
- cardiovascular disease, education, peer mentor
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational InterventionBehavioural
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, they will be invited to participate in the pilot intervention study. This is a single arm before-after study.subject education will focus on life style medication and adherence to medication (if applicable).importantly the peer mentor will try to identify barriers to adopting a healthy lifestyle(tobacco, physical acitivity, diet, alcohol and strees) and adherence to cardiovascular disease prevention medication. peer mentors will be trained to interpret blood glucose and lipids, recognize abnormal valves, provide lifestyle counseling and refer to treating physician when appropriate.
| Study group | Role | What they receive |
|---|---|---|
| lifestyle counseling | Experimental | we will have a trained peer mentor educating employees regarding lifestyle modification for control of cardiovascular disease risk factors and following them up for a duration of 3 months Receives: Behavioral: Educational Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in knowledge attitudes & practices related to Cardiovascular risk factors. (questionnaire)
A knowledge, attitudes \& practices questionnaire will be administered to participants
Measured: 1 Month
Identification of barriers and facilitators for an optimal Cardiovascular Health environment. (In depth interviews and focus groups discussions with random sample of participants)
qualitative analysis - In depth interviews and focus groups discussions with random sample of participants
Measured: 3 Months
Estimate the Cardiovascular risk factor burden (validated non lab based Cardiovascular risk score)
validated non lab based Cardiovascular risk score will be used (developed from NHANES data and validated against Framingham score
Measured: 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2015 (estimated)
- Study startMay 2015
- Primary completionOct 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 334 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. John's Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- International Centre for Diarrhoeal Disease Research, Bangladesh, University of Colombo, University of Oxford
- Responsible party
- Sponsor
- Investigators
- Dr Denis Xavier, M.D,MSc., Principal investigator, St.John's Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02388542
- Sponsor's protocol ID
- PROGRESS-IND-1022015
- Acronym
- PROGRESS
- Status last verified
- Oct 2016
- First submitted
- 9 Feb 2015
- Last updated
- 14 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Policy and Peer Mentor Intervention Programs on Cardiovascular Disease at Small to Medium Sized Worksites in 3 South Asian Countries - a Pilot Study for a Definitive Large International Cluster Randomized Trial
- ClinicalTrials.gov ID
- NCT02388542
- Acronym / sponsor ID
- PROGRESS / PROGRESS-IND-1022015
- Conditions
- Cardiovascular Disease
- Keywords
- cardiovascular disease, education, peer mentor
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 334 participants (actual)
- Lead sponsor
- St. John's Research InstituteUniversity, hospital or other
- Collaborators
- International Centre for Diarrhoeal Disease Research, Bangladesh, University of Colombo, University of Oxford
- Study start
- May 2015
- Primary completion
- Oct 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 17 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators propose conducting a pilot study to identify 6 worksites (2 India, 2 Sri Lanka, 2 Bangladesh) explore barriers to optimum cardiovascular disease(CVD) care at these worksites, quantify risk factor level in worksite populations and identify and train peer mentors to deliver an educational intervention to improve life style and enhance medication adherence among those at moderate to high risk of cardiovascular disease (CVD).
Detailed description
Eligibility Criteria -
All employees aged above 35 years at selected workplaces.
Study design - Mixed methods methods Phase 1 - Qualitative study; Phase 2 - Quantitative - Single group, non-randomized before-after comparison study + KAP survey
Sample size - Approximately 334 participants.
The study entails the following steps -
Step 1 - An evaluation for knowledge, attitudes and practices (KAP) related to cardiovascular health/ disease at worksites.
Step 2 - A qualitative study for barriers and facilitators of behaviors associated with optimal cardiovascular health
Step 3 - Baseline assessment of cardiovascular risk using a non-lab based risk assessment score
Step 4 - Piloting a trained peer mentored educational/ intensive follow-up intervention for 3 month with a re-assessment at 3 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| lifestyle counseling | Experimental | Behavioral: Educational Interventionwe will have a trained peer mentor educating employees regarding lifestyle modification for control of cardiovascular disease risk factors and following them up for a duration of 3 months |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- All criteria must be met to be eligible
Key exclusion criteria (6 listed)
- Subject ineligible if even one criterion is met
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational InterventionEmployees 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, they will be invited to participate in the pilot intervention study. This is a single arm before-after study.subject education will focus on life style medication and adherence to medication (if applicable).importantly the peer mentor will try to identify barriers to adopting a healthy lifestyle(tobacco, physical acitivity, diet, alcohol and strees) and adherence to cardiovascular disease prevention medication. peer mentors will be trained to interpret blood glucose and lipids, recognize abnormal valves, provide lifestyle counseling and refer to treating physician when appropriate. | Behavioural | lifestyle counseling |
Primary outcome
Change in knowledge attitudes & practices related to Cardiovascular risk factors. (questionnaire)
Time frame: 1 Month
A knowledge, attitudes \& practices questionnaire will be administered to participants
Identification of barriers and facilitators for an optimal Cardiovascular Health environment. (In depth interviews and focus groups discussions with random sample of participants)
Time frame: 3 Months
qualitative analysis - In depth interviews and focus groups discussions with random sample of participants
Estimate the Cardiovascular risk factor burden (validated non lab based Cardiovascular risk score)
Time frame: 3 Months
validated non lab based Cardiovascular risk score will be used (developed from NHANES data and validated against Framingham score
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr Denis Xavier, M.D,MSc. principal investigator
St.John's Medical College
6 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational Intervention in people with Cardiovascular Disease, run by St. John's Research Institute at 6 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Bangladesh, India, Sri Lanka. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in knowledge attitudes & practices related to Cardiovascular risk factors. (questionnaire) (time frame: 1 Month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2017.