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Randomized Trial of Behavioral Intervention Versus Standard Treatment (SUPRIM)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00888485
First Posted: April 27, 2009
Last Update Posted: April 27, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Uppsala University
  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
Intervention Model: Parallel Assignment
Masking: Single (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).

Further study details as provided by Uppsala University:

Primary Outcome Measures:
  • Admission to hospital for recurrent CHD event [ Time Frame: 8 years ]

Secondary Outcome Measures:
  • Quality of life measures [ Time Frame: 2 years ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 75 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00888485


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

Publications:
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
First Submitted: April 24, 2009
First Posted: April 27, 2009
Last Update Posted: April 27, 2009
Last Verified: April 2009

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