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Randomized Trial of Behavioral Intervention Versus Standard Treatment (SUPRIM)

This study has been completed.
Sponsor:
Information provided by:
Uppsala University
ClinicalTrials.gov Identifier:
NCT00888485
First received: April 24, 2009
Last updated: NA
Last verified: April 2009
History: No changes posted
  Purpose

The purpose of this study is to determine the possible preventive effect of behavioural modification versus standard treatment after hospital discharge in CHD patients.


Condition Intervention
Coronary Heart Disease
 Behavioral: Behavioral interventional program

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Secondary Prevention in Uppsala Primary Health Care After Myocardial Infarction, Coronary Artery CABG and PCI. Secondary Prevention After CHD (SUPRIM).

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Uppsala University:

Primary Outcome Measures:
  • Admission to hospital for recurrent CHD event [ Time Frame: 8 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quality of life measures [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment: 362
Study Start Date: May 1996
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Behavioral intervention
Group exposed to behavioral intervention program
 Behavioral: Behavioral interventional program
Cognitive behavioral therapy intervention adapted to coronary disease patients performed in 20 group sessions during one year.
Active Comparator: Standard treatment Behavioral: Behavioral interventional program
Cognitive behavioral therapy intervention adapted to coronary disease patients performed in 20 group sessions during one year.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Discharged from hospital with CHD
  • Age 75 years or less
  • Living in hospital catchment area
  • Able to understand Swedish
  • Willing to accept randomized group

Exclusion Criteria:

  • Psychiatric disease
  • Participated in similar study previously
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00888485

Sponsors and Collaborators
Uppsala University
Investigators
Principal Investigator: Kurt Svärdsudd, MD PhD Uppsala University
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Professor Kurt Svärdsudd, Section head, Uppsala University, Department of Public Health and Caring Scienses
ClinicalTrials.gov Identifier: NCT00888485     History of Changes
Other Study ID Numbers: SMRK97, Vardal V96, FAS F0196, SOS 1471, SHLA E010
Study First Received: April 24, 2009
Last Updated: April 24, 2009
Health Authority: Sweden: The National Board of Health and Welfare

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Myocardial Infarction
 Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on May 21, 2013