NCT00956657

Brief Summary

Cardiac rehabilitation (CR) programmes typically offer patients with heart disease a long-term programme of medical evaluation, exercise, education and counseling. National guidelines have recognized the positive impact that attendance at CR can have following heart attacks, angina and other heart problems. Patients who attend such a programme have been shown to have reduced health problems. Despite this, research suggests that the use of these services is poor and that the majority of patients eligible for these programmes do not continue to attend after their first class. A range of factors have been associated with non-adherence to CR, including psychological factors such as people's beliefs about their illness. For example, patients with high levels of perceived control over their illness after a heart attack appear to be more likely to attend CR classes than those with low levels of perceived control. Such findings suggest that changing patients' illness beliefs, specifically those associated with illness control and illness consequences, could help to increase adherence to CR programmes. Increased adherence to CR could improve health outcomes for patients with cardiac illnesses. The present study is therefore investigating the effectiveness of a one-session psychological intervention, based on a theory called the Self-Regulatory Model, in altering beliefs about illness among patients starting cardiac rehabilitation. Participants will be randomly assigned to a treatment or a non-treatment group. It is hoped that those who receive the treatment session will attend more CR classes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2008

Shorter than P25 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2008

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

August 10, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 11, 2009

Completed
9 months until next milestone

Results Posted

Study results publicly available

May 12, 2010

Completed
Last Updated

May 12, 2010

Status Verified

August 1, 2009

Enrollment Period

9 months

First QC Date

August 10, 2009

Results QC Date

March 11, 2010

Last Update Submit

April 22, 2010

Conditions

Keywords

Randomised Controlled TrialAdherencePatient Participation

Outcome Measures

Primary Outcomes (1)

  • CR Adherence

    Number of cardiac rehabilitation classes attended in total.

    Approximately 3-months after recruitment

Secondary Outcomes (1)

  • Illness Perceptions Questionnaire-Revised Scores

    3-months after consent

Interventions

One-off session aimed at changing participants beliefs around illness control and consequences, applied using a motivational interviewing style.

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Attending first cardiac rehabilitation class at one of three hospital sites
  • Participants had to be over 18

You may not qualify if:

  • Unable to read and understand English information sheet and consent form

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Southern General Hospital

Glasgow, United Kingdom

Location

Stobhill Infirmary

Glasgow, United Kingdom

Location

Victoria Infirmary

Glasgow, United Kingdom

Location

MeSH Terms

Conditions

Patient Participation

Condition Hierarchy (Ancestors)

Patient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Limitations and Caveats

The small sample size of this study does not allow definitive conclusions to be drawn about the success or failure or this intervention approach.

Results Point of Contact

Title
Gavin H. Taylor, Clinical Psychologist
Organization
NHS Greater Glasgow & Clyde

Study Officials

  • Gavin H Taylor, MA (Hons)

    NHS Greater Glasgow & Clyde

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 10, 2009

First Posted

August 11, 2009

Study Start

November 1, 2008

Primary Completion

August 1, 2009

Study Completion

August 1, 2009

Last Updated

May 12, 2010

Results First Posted

May 12, 2010

Record last verified: 2009-08

Locations