Trial Outcomes & Findings for Improving Cardiac Rehabilitation Session Attendance: A Randomised Controlled Trial (NCT NCT00956657)

NCT ID: NCT00956657

Last Updated: 2010-05-12

Results Overview

Number of cardiac rehabilitation classes attended in total.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

31 participants

Primary outcome timeframe

Approximately 3-months after recruitment

Results posted on

2010-05-12

Participant Flow

Recruitment began in November 2008 and was completed in May 2009. All recruitment took place in out-patient cardiac rehabilitation departments within hospital buildings.

Participant milestones

Participant milestones
Measure
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.
Overall Study
STARTED
18
13
Overall Study
COMPLETED
18
13
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Improving Cardiac Rehabilitation Session Attendance: A Randomised Controlled Trial

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Treatment Group
n=18 Participants
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
n=13 Participants
Control group. Treatment received as usual.
Total
n=31 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=93 Participants
0 Participants
n=4 Participants
0 Participants
n=27 Participants
Age, Categorical
Between 18 and 65 years
12 Participants
n=93 Participants
9 Participants
n=4 Participants
21 Participants
n=27 Participants
Age, Categorical
>=65 years
6 Participants
n=93 Participants
4 Participants
n=4 Participants
10 Participants
n=27 Participants
Age Continuous
63 years
STANDARD_DEVIATION 9.6 • n=93 Participants
61 years
STANDARD_DEVIATION 10.6 • n=4 Participants
62 years
STANDARD_DEVIATION 9.9 • n=27 Participants
Sex: Female, Male
Female
4 Participants
n=93 Participants
2 Participants
n=4 Participants
6 Participants
n=27 Participants
Sex: Female, Male
Male
14 Participants
n=93 Participants
11 Participants
n=4 Participants
25 Participants
n=27 Participants
Region of Enrollment
United Kingdom
18 participants
n=93 Participants
13 participants
n=4 Participants
31 participants
n=27 Participants

PRIMARY outcome

Timeframe: Approximately 3-months after recruitment

Number of cardiac rehabilitation classes attended in total.

Outcome measures

Outcome measures
Measure
Treatment Group
n=18 Participants
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
n=13 Participants
Control group. Treatment received as usual.
CR Adherence
16.0 Classes Attended
Standard Deviation 5.2
14.4 Classes Attended
Standard Deviation 6.2

SECONDARY outcome

Timeframe: 3-months after consent

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.

Outcome measures

Outcome data not reported

Adverse Events

Treatment Group

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Treatment As Usual

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Gavin H. Taylor, Clinical Psychologist

NHS Greater Glasgow & Clyde

Phone: 0141 211 2134

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place