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Randomized Trial of Behavioral Intervention Versus Standard Treatment (SUPRIM)

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.
ClinicalTrials.gov Identifier: NCT00888485
Recruitment Status : Completed
First Posted : April 27, 2009
Last Update Posted : April 27, 2009
Sponsor:
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment
Coronary Heart Disease Behavioral: Behavioral interventional program

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 362 participants
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).
Study Start Date : May 1996
Primary Completion Date : December 2008
Study Completion Date : December 2008
Arms and Interventions

Arm Intervention/treatment
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.


Outcome Measures

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

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

Eligibility Criteria

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 Posted: April 27, 2009    Key Record Dates
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