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Improving Cardiac Rehabilitation Session Attendance: A Randomised Controlled Trial

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00956657
First Posted: August 11, 2009
Last Update Posted: May 12, 2010
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:
NHS Greater Glasgow and Clyde
Results First Submitted: 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 
Overall Participants Analyzed 
[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 reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

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



Responsible Party: Gavin Taylor, Clinical Psychologist, NHS Greater Glasgow & Clyde
ClinicalTrials.gov Identifier: NCT00956657     History of Changes
Other Study ID Numbers: 08/S0710/65
First Submitted: August 10, 2009
First Posted: August 11, 2009
Results First Submitted: March 11, 2010
Results First Posted: May 12, 2010
Last Update Posted: May 12, 2010