NCT00888485

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
362

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 1996

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 1996

Completed
12.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 24, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 27, 2009

Completed
Last Updated

April 27, 2009

Status Verified

April 1, 2009

Enrollment Period

12.6 years

First QC Date

April 24, 2009

Last Update Submit

April 24, 2009

Conditions

Coronary Heart Disease

Outcome Measures

Primary Outcomes (1)

  • Admission to hospital for recurrent CHD event

    8 years

Secondary Outcomes (1)

  • Quality of life measures

    2 years

Study Arms (2)

Behavioral intervention

EXPERIMENTAL

Group exposed to behavioral intervention program

Behavioral: Behavioral interventional program

Standard treatment

ACTIVE COMPARATOR
Behavioral: Behavioral interventional program

Interventions

Behavioral interventional programBEHAVIORAL

Cognitive behavioral therapy intervention adapted to coronary disease patients performed in 20 group sessions during one year.

Behavioral interventionStandard treatment

Eligibility Criteria

AgeUp to 75 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Psychiatric disease
  • Participated in similar study previously

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Gulliksson M, Burell G, Lundin L, Toss H, Svardsudd K. Psychosocial factors during the first year after a coronary heart disease event in cases and referents. Secondary Prevention in Uppsala Primary Health Care Project (SUPRIM). BMC Cardiovasc Disord. 2007 Nov 21;7:36. doi: 10.1186/1471-2261-7-36.

    PMID: 18031575RESULT

  • Gulliksson M, Burell G, Vessby B, Lundin L, Toss H, Svardsudd K. Randomized controlled trial of cognitive behavioral therapy vs standard treatment to prevent recurrent cardiovascular events in patients with coronary heart disease: Secondary Prevention in Uppsala Primary Health Care project (SUPRIM). Arch Intern Med. 2011 Jan 24;171(2):134-40. doi: 10.1001/archinternmed.2010.510.

    PMID: 21263103DERIVED

MeSH Terms

Conditions

Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Kurt Svärdsudd, MD PhD

    Uppsala University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 24, 2009

First Posted

April 27, 2009

Study Start

May 1, 1996

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

April 27, 2009

Record last verified: 2009-04