Secondary Prevention of coRonary Events After Discharge From Hospital (SPREAD)
This study is currently recruiting participants.
Verified June 2012 by St. John's Research Institute
Sponsor:
St. John's Research Institute
Collaborator:
National Heart and Lung Institute
Information provided by (Responsible Party):
Dr Alben Sigamani, St. John's Research Institute
ClinicalTrials.gov Identifier:
NCT01207700
First received: September 22, 2010
Last updated: June 5, 2012
Last verified: June 2012
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Purpose
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)
| Condition | Intervention |
|---|---|
|
Acute Coronary Syndrome |
Behavioral: Community Health Worker, VITA Tool Other: No intervention |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Supportive Care |
| Official Title: | A Randomized, Open Trial Comparing Post Discharge Interventions to Standard Care |
Resource links provided by NLM:
Further study details as provided by St. John's Research Institute:
Primary Outcome Measures:
- To obtain estimates of rates of adherence to pharmacotherapy and lifestyle modification interventions and the incidence of major cardiovascular events [ Time Frame: 12 months ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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
| Estimated Enrollment: | 800 |
| Study Start Date: | August 2011 |
| Estimated Study Completion Date: | June 2013 |
| Estimated Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
SPREAD Tools
Home visits by the community health worker, tools for reminders to take medications, material for patients awareness of the importance of secondary prevention
|
Behavioral: Community Health Worker, VITA Tool
The community Health Worker will use the V
Other Names:
|
|
Standard Care
Patients will be followed upto 12 months without a community health worker intervention as per standard practices of the hospital
|
Other: No intervention
regular hospital based practice
Other Names:
|
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.
Eligibility| Ages Eligible for Study: | 45 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01207700
Contacts
| Contact: Dr. Denis Xavier, MD | denis@sjri.res.in | |
| Contact: Dr. Alben Sigamani, MD | alben@sjri.res.in |
Locations
| India | |
| Krishna Institute of Medical Science Ltd | Recruiting |
| Secunderabad, Aandhra Pradesh, India, 500003 | |
| Contact: Dr. Rajendra Kumar, MD, DM 9848029443 | |
| Contact kumarpre@hotmail.com | |
| Principal Investigator: Dr. Rajendra Kumar, MD, DM | |
| Mahavir Hospital & Research Centre | Recruiting |
| Hyderabad, Andhra Pradesh, India, 500004 | |
| Contact: Dr. Sindhu Joshi, DNB 939109991 dr_sindhu@yahoo.com | |
| Principal Investigator: Dr. Sindhu Joshi, DNB | |
| Nanjappa Hospital | Recruiting |
| Shimoga, Karnataka, India, 577201 | |
| Contact: Dr. J. Narendra, MD, DM 8182225085 jncardiology@gmail.com | |
| Principal Investigator: Dr. J Narendra, MD, DM | |
| Caritas Hospital | Recruiting |
| Kottayam, Kerala, India | |
| Contact: Dr.Johny Joseph, MD, DM drjohnyjoseph@gmail.com | |
| Principal Investigator: Dr.Johny Joseph, MD, DM | |
| Bhopal Memorial Hospital | Recruiting |
| Bhopal, Madhya Pradesh, India, 462038 | |
| Contact: Dr. Skand K Trivedi, MD, DM | |
| Principal Investigator: Dr. Skand K Trivedi, MD, DM | |
| Avanti Institute of Cardiology | Recruiting |
| Nagpur, Maharastra, India, 440012 | |
| Contact: Dr. U.K Mahokar, DM, DNB | |
| Principal Investigator: Dr. U.K Mahokar, MD, DNB | |
| Poona Hospital | Recruiting |
| Pune, Maharastra, India | |
| Contact: Dr.Jagdish Hiremath 9822022441 jagdish_hiremath@vsnl.net | |
| Principal Investigator: Dr.Jagdish Hiremath | |
| Mahatma Gandhi Institute of Medical Science Sevagram | Recruiting |
| Wardha, Maharastra, India, 442001 | |
| Contact: Dr.S.P. Kalantri, MD 9970168766 sp.kalantri@gmail.com | |
| Principal Investigator: Dr.S.P. Kalantri, MD | |
| Fortis Escorts Hospital | Recruiting |
| Jaipur, Rajasthan, India, 302017 | |
| Contact: Dr. Rajeev Gupta, MD, Ph.d | |
| Principal Investigator: Dr. Rajeev Gupta | |
| Rajamuthiah Medical College & Hospital | Recruiting |
| Annamalai, Tamil Nadu, India, 608 002 | |
| Contact: Dr. N Chidambaram, MD "9894048397/9345628680" deanrmmc@yahoo.com | |
| Principal Investigator: Dr. N Chidambaram, MD | |
| PSG Hospital | Not yet recruiting |
| Coimbatore, Tamil Nadu, India, 641 004 | |
| Contact: Dr T Manikandan, MBBS, DPMR | |
| Principal Investigator: Dr. T Manikandan, MBBS, DPMR | |
| Sahara Hospital | Recruiting |
| Lucknow, Uttar Pradesh, India, 226010 | |
| Contact: NAKUL SINHA, MD DM research.sahara@gmail.com | |
| Contact: SANDEEP MISHRA, MD research.sahara@gmail.com | |
| Sanjay Gandhi Post Graduate Institute of Medical Sciences | Withdrawn |
| Lucknow, Uttar Pradesh, India, 226 014 | |
| Sir Ganga Ram Hospital | Recruiting |
| New Delhi, India, 110060 | |
| Contact: Dr.J P S Sawhney, MD, DM 9810059773 jpssawhney@yahoo.com | |
| Principal Investigator: Dr.J P S Sawhney, MD, DM | |
Sponsors and Collaborators
St. John's Research Institute
National Heart and Lung Institute
Investigators
| Principal Investigator: | Dr. Rajeev Gupta, MD, PHD | Fortis Escorts Hospital, Jaipur |
More Information
No publications provided
| Responsible Party: | Dr Alben Sigamani, Associate Professor, St. John's Research Institute |
| ClinicalTrials.gov Identifier: | NCT01207700 History of Changes |
| Other Study ID Numbers: | NO1-HV-98215/SJRI - DCT/SPREAD |
| Study First Received: | September 22, 2010 |
| Last Updated: | June 5, 2012 |
| Health Authority: | India: Indian Council of Medical Research India: Ministry of Health |
Keywords provided by St. John's Research Institute:
|
post discharge intervention adherence compliance community health worker |
Additional relevant MeSH terms:
|
Acute Coronary Syndrome Myocardial Ischemia Heart Diseases Cardiovascular Diseases Angina Pectoris Vascular Diseases Chest Pain Pain Signs and Symptoms |
Tocopherols Antioxidants Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Protective Agents Physiological Effects of Drugs Vitamins Micronutrients Growth Substances |
ClinicalTrials.gov processed this record on May 21, 2013