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

History of Changes

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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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 ]

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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

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Other Adverse Events

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More Information

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Certain Agreements:

All Principal Investigators ARE employed by the organization sponsoring the study.

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.

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

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