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Improving Cardiac Rehabilitation Session Attendance: A Randomised Controlled Trial

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: NCT00956657
Recruitment Status : Completed
First Posted : August 11, 2009
Results First Posted : May 12, 2010
Last Update Posted : May 12, 2010
Sponsor:
Information provided by:
NHS Greater Glasgow and Clyde

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Primary Purpose: Health Services Research
Condition Cardiac Rehabilitation
Intervention Behavioral: Psychological Intervention Session
Enrollment 31
Recruitment Details 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  
Arm/Group Title Treatment Group Treatment As Usual
Hide Arm/Group Description 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. Control group. Treatment received as usual.
Period Title: Overall Study
Started 18 13
Completed 18 13
Not Completed 0 0
Arm/Group Title Treatment Group Treatment As Usual Total
Hide Arm/Group Description 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. Control group. Treatment received as usual. Total of all reporting groups
Overall Number of Baseline Participants 18 13 31
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 13 participants 31 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
12
  66.7%
9
  69.2%
21
  67.7%
>=65 years
6
  33.3%
4
  30.8%
10
  32.3%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 18 participants 13 participants 31 participants
63  (9.6) 61  (10.6) 62  (9.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 13 participants 31 participants
Female
4
  22.2%
2
  15.4%
6
  19.4%
Male
14
  77.8%
11
  84.6%
25
  80.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United Kingdom Number Analyzed 18 participants 13 participants 31 participants
18 13 31
1.Primary Outcome
Title CR Adherence
Hide Description Number of cardiac rehabilitation classes attended in total.
Time Frame Approximately 3-months after recruitment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment Group Treatment As Usual
Hide Arm/Group Description:
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.
Control group. Treatment received as usual.
Overall Number of Participants Analyzed 18 13
Mean (Standard Deviation)
Unit of Measure: Classes Attended
16.0  (5.2) 14.4  (6.2)
2.Secondary Outcome
Title Illness Perceptions Questionnaire-Revised Scores
Hide Description Eight sub-scale scores obtained. Sub-scales include; Illness consequences, Illness Control, Treatment Control, Illness Identity, Emotional Representation, Illness Cause, Illness Coherence, Timeline Cyclical. Minimum and Maximum scores vary for each sub-scale.
Time Frame 3-months after consent
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment Group Treatment As Usual
Hide Arm/Group Description 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. Control group. Treatment received as usual.
All-Cause Mortality
Treatment Group Treatment As Usual
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Treatment Group Treatment As Usual
Affected / at Risk (%) Affected / at Risk (%)
Total   0/18 (0.00%)   0/13 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Treatment Group Treatment As Usual
Affected / at Risk (%) Affected / at Risk (%)
Total   0/18 (0.00%)   0/13 (0.00%) 
The small sample size of this study does not allow definitive conclusions to be drawn about the success or failure or this intervention approach.
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
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