Improving Cardiac Rehabilitation Session Attendance: A Randomised Controlled Trial

This study has been completed.
Sponsor:
Information provided by:
NHS Greater Glasgow and Clyde
ClinicalTrials.gov Identifier:
NCT00956657
First received: August 10, 2009
Last updated: April 22, 2010
Last verified: August 2009
Results First Received: March 11, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Primary Purpose: Health Services Research
Condition: Cardiac Rehabilitation
Intervention: Behavioral: Psychological Intervention Session

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment began in November 2008 and was completed in May 2009. All recruitment took place in out-patient cardiac rehabilitation departments within hospital buildings.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Treatment Group Single treatment session provided by study PI. Session aimed to change participant illness beliefs using motivational interviewing techniques in order to improve adherence to cardiac rehabilitation classes.
Treatment As Usual Control group. Treatment received as usual.

Participant Flow:   Overall Study
    Treatment Group     Treatment As Usual  
STARTED     18     13  
COMPLETED     18     13  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Treatment Group Single treatment session provided by study PI. Session aimed to change participant illness beliefs using motivational interviewing techniques in order to improve adherence to cardiac rehabilitation classes.
Treatment As Usual Control group. Treatment received as usual.
Total Total of all reporting groups

Baseline Measures
    Treatment Group     Treatment As Usual     Total  
Number of Participants  
[units: participants]
  18     13     31  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     12     9     21  
>=65 years     6     4     10  
Age  
[units: years]
Mean ± Standard Deviation
  63  ± 9.6     61  ± 10.6     62  ± 9.9  
Gender  
[units: participants]
     
Female     4     2     6  
Male     14     11     25  
Region of Enrollment  
[units: participants]
     
United Kingdom     18     13     31  



  Outcome Measures

1.  Primary:   CR Adherence   [ Time Frame: Approximately 3-months after recruitment ]

2.  Secondary:   Illness Perceptions Questionnaire-Revised Scores   [ Time Frame: 3-months after consent ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The small sample size of this study does not allow definitive conclusions to be drawn about the success or failure or this intervention approach.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Gavin H. Taylor, Clinical Psychologist
Organization: NHS Greater Glasgow & Clyde
phone: 0141 211 2134
e-mail: gavin.taylor@ggc.scot.nhs.uk


No publications provided


Responsible Party: Gavin Taylor, Clinical Psychologist, NHS Greater Glasgow & Clyde
ClinicalTrials.gov Identifier: NCT00956657     History of Changes
Other Study ID Numbers: 08/S0710/65
Study First Received: August 10, 2009
Results First Received: March 11, 2010
Last Updated: April 22, 2010
Health Authority: United Kingdom: Research Ethics Committee