Acute Coronary SyndromeSPREADNCT01207700
Secondary Prevention of coRonary Events After Discharge From Hospital (SPREAD)
A study testing CHW based intervention post ACS in people with Acute Coronary Syndrome, run by St. John's Research Institute at 13 sites in India.
Trial summary
This is a randomized, open trial comparing post discharge interventions by community health workers (CHW) to standard care in acute coronary syndrome (ACS) patients. This trial will be conducted in 10 hospitals in India/different parts(both secondary and tertiary care). Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Acute Coronary Syndrome
- What is being tested?
- CHW based intervention post ACS
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 806 participants
- Where
- 13 sitesIndia
- Study dates
- Aug 2011to Aug 2013
- 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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Consenting patients being discharged after an acute coronary event such as unstable angina, acute myocardial infarction, or after coronary intervention (CABG surgery or PCI).
Who cannot join
- Patients with other terminal/ debilitating illness, (e.g., advanced cancer, disabling stroke) those not expected to survive for the study duration, those with dementia and psychiatric illness or patients unlikely to comply with study requirements, including regular follow up
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
India13 sites
Rajamuthiah Medical College & Hospital
Annāmalainagar, Tamil Nadu, 608 002
Bhopal Memorial Hospital
Bhopal, Madhya Pradesh, 462038
PSG Hospital
Coimbatore, Tamil Nadu, 641 004
Mahavir Hospital & Research Centre
Hyderabad, Andhra Pradesh, 500004
Fortis Escorts Hospital
Jaipur, Rajasthan, 302017
Caritas Hospital
Kottayam, Kerala
Sahara Hospital
Lucknow, Uttar Pradesh, 226010
Avanti Institute of Cardiology
Nagpur, Maharashtra, 440012
Sir Ganga Ram Hospital
New Delhi, New Delhi, 110060
Poona Hospital
Pune, Maharashtra
Krishna Institute of Medical Science Ltd
Secunderabad, Aandhra Pradesh, 500003
Nanjappa Hospital
Shimoga, Karnataka, 577201
Mahatma Gandhi Institute of Medical Science Sevagram
Wardha, Maharashtra, 442001
About this study
Official title: A Randomized, Open Trial Comparing Post Discharge Interventions to Standard Care
This is a randomized, open trial comparing post discharge interventions by community health workers (CHW) to standard care in acute coronary syndrome (ACS) patients.
This trial will be conducted in 10 hospitals in India/different parts(both secondary and tertiary care). A total of 800 patients will be recruited, with equal allocation to SPREAD interventions and control groups (usual care)
Read the detailed description
Inclusion criteria:
Consenting patients being discharged after an acute coronary event such as unstable angina, acute myocardial infarction, or after coronary intervention (CABG surgery or PCI).
Exclusion criteria:
Patients with other terminal/ debilitating illness, (e.g., advanced cancer, disabling stroke) those not expected to survive for the study duration, those with dementia and psychiatric illness or patients unlikely to comply with study requirements, including regular follow up.
OUTCOME MEASURES:
- Feasibility
- Difference in adherence to specific medications for secondary prevention of CAD (Coronary Artery Diseases) compared to the control group, at one year.
- Conditions
- Acute Coronary Syndrome
- Being tested
- CHW based intervention post ACS
- Keywords
- post discharge intervention, adherence, compliance, community health worker
- Medical subject headings
- Acute Coronary Syndrome, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CHW based intervention post ACSBehavioural
CHW is trained and supervised to provide interventions that could improved adherence to post ACS care
| Study group | Role | What they receive |
|---|---|---|
| CHW based intervention post ACS | Experimental | CHW trained and supervised for intervening upon post ACS patients to improve adherence to evidence based care Receives: Behavioral: CHW based intervention post ACS |
| Standard Care | No intervention | Patients will be followed upto 12 months without a community health worker intervention as per standard practices of the hospital |
What is being measured
The primary outcome is the main question the study is designed to answer.
To obtain estimates of rates of adherence to pharmacotherapy and lifestyle modification interventions and the incidence of major cardiovascular events
Evaluate the rates of adherence to pharmacotherapy and lifestyle modifications using the community health worker
Measured: 12 months
To determine the feasibility of conducting a secondary prevention trial using CDCHWs on adherence to medications and lifestyle advice
A pilot study to look at feasibiility of using a trained community health worker to deliver health messages to patients who have had a coronary event
Measured: 12 MONTHS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2010 (estimated)
- Study startAug 2011
- Primary completionJul 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromeStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 806 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. John's Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart and Lung Institute
- Responsible party
- Principal investigator, Dr Alben Sigamani, St. John's Research Institute
- Investigators
- Dr. Rajeev Gupta, MD, PHD, Principal investigator, Fortis Escorts Hospital, Jaipur
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01207700
- Sponsor's protocol ID
- NO1-HV-98215/SJRI - DCT/SPREAD
- Acronym
- SPREAD
- Status last verified
- Nov 2014
- First submitted
- 22 Sep 2010
- Last updated
- 2 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Xavier D, Gupta R, Kamath D, Sigamani A, Devereaux PJ, George N, Joshi R, Pogue J, Pais P, Yusuf S. Community health worker-based intervention for adherence to drugs and lifestyle change after acute coronary syndrome: a multicentre, open, randomised controlled trial. Lancet Diabetes Endocrinol. 2016 Mar;4(3):244-253. doi: 10.1016/S2213-8587(15)00480-5. Epub 2016 Feb 6.
PubMed 26857999
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open Trial Comparing Post Discharge Interventions to Standard Care
- ClinicalTrials.gov ID
- NCT01207700
- Acronym / sponsor ID
- SPREAD / NO1-HV-98215/SJRI - DCT/SPREAD
- Conditions
- Acute Coronary Syndrome
- Keywords
- post discharge intervention, adherence, compliance, community health worker
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 806 participants (actual)
- Lead sponsor
- St. John's Research InstituteUniversity, hospital or other
- Collaborators
- National Heart and Lung Institute
- Study start
- Aug 2011
- Primary completion
- Jul 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 23 Sep 2010 (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.
This is a randomized, open trial comparing post discharge interventions by community health workers (CHW) to standard care in acute coronary syndrome (ACS) patients.
This trial will be conducted in 10 hospitals in India/different parts(both secondary and tertiary care). A total of 800 patients will be recruited, with equal allocation to SPREAD interventions and control groups (usual care)
Detailed description
Inclusion criteria:
Consenting patients being discharged after an acute coronary event such as unstable angina, acute myocardial infarction, or after coronary intervention (CABG surgery or PCI).
Exclusion criteria:
Patients with other terminal/ debilitating illness, (e.g., advanced cancer, disabling stroke) those not expected to survive for the study duration, those with dementia and psychiatric illness or patients unlikely to comply with study requirements, including regular follow up.
OUTCOME MEASURES:
- Feasibility
- Difference in adherence to specific medications for secondary prevention of CAD (Coronary Artery Diseases) compared to the control group, at one year.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CHW based intervention post ACS | Experimental | Behavioral: CHW based intervention post ACSCHW trained and supervised for intervening upon post ACS patients to improve adherence to evidence based care |
| Standard Care | No intervention | –Patients will be followed upto 12 months without a community health worker intervention as per standard practices of the hospital |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Consenting patients being discharged after an acute coronary event such as unstable angina, acute myocardial infarction, or after coronary intervention (CABG surgery or PCI).
Key exclusion criteria (1 listed)
- Patients with other terminal/ debilitating illness, (e.g., advanced cancer, disabling stroke) those not expected to survive for the study duration, those with dementia and psychiatric illness or patients unlikely to comply with study requirements, including regular follow up
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 |
|---|---|---|
| CHW based intervention post ACSCHW is trained and supervised to provide interventions that could improved adherence to post ACS care | Behavioural | CHW based intervention post ACS |
Primary outcome
To obtain estimates of rates of adherence to pharmacotherapy and lifestyle modification interventions and the incidence of major cardiovascular events
Time frame: 12 months
Evaluate the rates of adherence to pharmacotherapy and lifestyle modifications using the community health worker
To determine the feasibility of conducting a secondary prevention trial using CDCHWs on adherence to medications and lifestyle advice
Time frame: 12 MONTHS
A pilot study to look at feasibiility of using a trained community health worker to deliver health messages to patients who have had a coronary event
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2014.
- Derived from this study: PubMed 26857999Xavier D, Gupta R, Kamath D, Sigamani A, Devereaux PJ, George N, Joshi R, Pogue J, Pais P, Yusuf S. Community health worker-based intervention for adherence to drugs and lifestyle change after acute coronary syndrome: a multicentre, open, randomised controlled trial. Lancet Diabetes Endocrinol. 2016 Mar;4(3):244-253. doi: 10.1016/S2213-8587(15)00480-5. Epub 2016 Feb 6.
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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. Rajeev Gupta, MD, PHD principal investigator
Fortis Escorts Hospital, Jaipur
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CHW based intervention post ACS in people with Acute Coronary Syndrome, run by St. John's Research Institute at 13 sites in India.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 2 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in India. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To obtain estimates of rates of adherence to pharmacotherapy and lifestyle modification interventions and the incidence of major cardiovascular events (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01207700, which also lists 1 linked publication.
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 2 Dec 2014.