Secondary Prevention of coRonary Events After Discharge From Hospital (SPREAD)

This study is ongoing, but not recruiting participants.
Sponsor:
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: May 28, 2013
Last verified: May 2013
  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: August 2013
Estimated Primary Completion Date: July 2013 (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:
  • A) Patient Reinforcement Form
  • B) Patient Diary
  • D) The VIsual Tool for Adherence (VITA)
  • E) Poster for Life Style Modification & Heart Disease Education
  • F) The Simplified Medication Adherence Questionnaire (SMAQ)
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:
  • clinical follow up
  • post discharge follow up

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:

  1. Feasibility
  2. 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01207700

Locations
India
Krishna Institute of Medical Science Ltd
Secunderabad, Aandhra Pradesh, India, 500003
Mahavir Hospital & Research Centre
Hyderabad, Andhra Pradesh, India, 500004
Nanjappa Hospital
Shimoga, Karnataka, India, 577201
Caritas Hospital
Kottayam, Kerala, India
Bhopal Memorial Hospital
Bhopal, Madhya Pradesh, India, 462038
Avanti Institute of Cardiology
Nagpur, Maharastra, India, 440012
Poona Hospital
Pune, Maharastra, India
Mahatma Gandhi Institute of Medical Science Sevagram
Wardha, Maharastra, India, 442001
Fortis Escorts Hospital
Jaipur, Rajasthan, India, 302017
Rajamuthiah Medical College & Hospital
Annamalai, Tamil Nadu, India, 608 002
PSG Hospital
Coimbatore, Tamil Nadu, India, 641 004
Sahara Hospital
Lucknow, Uttar Pradesh, India, 226010
Sir Ganga Ram Hospital
New Delhi, India, 110060
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: May 28, 2013
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 September 15, 2014