Cardiac RehabilitationNCT00956657
Improving Cardiac Rehabilitation Session Attendance: A Randomised Controlled Trial
A study testing Psychological Intervention Session in people with Cardiac Rehabilitation, run by NHS Greater Glasgow and Clyde at 3 sites in United Kingdom.
Trial summary
Cardiac rehabilitation (CR) programmes typically offer patients with heart disease a long-term programme of medical evaluation, exercise, education and counseling. National guidelines have recognized the positive impact that attendance at CR can have following heart attacks, angina and other heart problems. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Rehabilitation
- What is being tested?
- Psychological Intervention Session
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 31 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- Nov 2008to Aug 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- Attending first cardiac rehabilitation class at one of three hospital sites
- Participants had to be over 18
Who cannot join
- Unable to read and understand English information sheet and consent form
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites
Southern General Hospital
Glasgow
Stobhill Infirmary
Glasgow
Victoria Infirmary
Glasgow
About this study
Official title: Improving Cardiac Rehabilitation Session Attendance Using the Self-Regulatory Model and Motivational Interviewing: A Randomised Controlled Trial
Cardiac rehabilitation (CR) programmes typically offer patients with heart disease a long-term programme of medical evaluation, exercise, education and counseling. National guidelines have recognized the positive impact that attendance at CR can have following heart attacks, angina and other heart problems. Patients who attend such a programme have been shown to have reduced health problems. Despite this, research suggests that the use of these services is poor and that the majority of patients eligible for these programmes do not continue to attend after their first class. A range of factors have been associated with non-adherence to CR, including psychological factors such as people's beliefs about their illness. For example, patients with high levels of perceived control over their illness after a heart attack appear to be more likely to attend CR classes than those with low levels of perceived control. Such findings suggest that changing patients' illness beliefs, specifically those associated with illness control and illness consequences, could help to increase adherence to CR programmes. Increased adherence to CR could improve health outcomes for patients with cardiac illnesses. The present study is therefore investigating the effectiveness of a one-session psychological intervention, based on a theory called the Self-Regulatory Model, in altering beliefs about illness among patients starting cardiac rehabilitation. Participants will be randomly assigned to a treatment or a non-treatment group. It is hoped that those who receive the treatment session will attend more CR classes.
- Conditions
- Cardiac Rehabilitation
- Being tested
- Psychological Intervention Session
- Keywords
- Randomised Controlled Trial, Adherence, Patient Participation
- Medical subject headings
- Patient Participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychological Intervention SessionBehavioural
One-off session aimed at changing participants beliefs around illness control and consequences, applied using a motivational interviewing style.
What is being measured
The primary outcome is the main question the study is designed to answer.
CR Adherence
Number of cardiac rehabilitation classes attended in total.
Measured: Approximately 3-months after recruitment
Secondary outcomes (1)
Illness Perceptions Questionnaire-Revised Scores
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.
Measured: 3-months after consent
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2009 (estimated)
- Study startNov 2008
- Primary completionAug 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cardiac RehabilitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- NHS Greater Glasgow and Clyde
- Sponsor type
- University, hospital or other
- Investigators
- Gavin H Taylor, MA (Hons), Principal investigator, NHS Greater Glasgow and Clyde
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00956657
- Sponsor's protocol ID
- 08/S0710/65
- Status last verified
- Aug 2009
- First submitted
- 10 Aug 2009
- Last updated
- 12 May 2010
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Cardiac Rehabilitation Session Attendance Using the Self-Regulatory Model and Motivational Interviewing: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT00956657
- Acronym / sponsor ID
- 08/S0710/65
- Conditions
- Cardiac Rehabilitation
- Keywords
- Randomised Controlled Trial, Adherence, Patient Participation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- NHS Greater Glasgow and ClydeUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 11 Aug 2009 (estimated)
- Results
- Posted 12 May 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Cardiac rehabilitation (CR) programmes typically offer patients with heart disease a long-term programme of medical evaluation, exercise, education and counseling. National guidelines have recognized the positive impact that attendance at CR can have following heart attacks, angina and other heart problems. Patients who attend such a programme have been shown to have reduced health problems. Despite this, research suggests that the use of these services is poor and that the majority of patients eligible for these programmes do not continue to attend after their first class. A range of factors have been associated with non-adherence to CR, including psychological factors such as people's beliefs about their illness. For example, patients with high levels of perceived control over their illness after a heart attack appear to be more likely to attend CR classes than those with low levels of perceived control. Such findings suggest that changing patients' illness beliefs, specifically those associated with illness control and illness consequences, could help to increase adherence to CR programmes. Increased adherence to CR could improve health outcomes for patients with cardiac illnesses. The present study is therefore investigating the effectiveness of a one-session psychological intervention, based on a theory called the Self-Regulatory Model, in altering beliefs about illness among patients starting cardiac rehabilitation. Participants will be randomly assigned to a treatment or a non-treatment group. It is hoped that those who receive the treatment session will attend more CR classes.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Attending first cardiac rehabilitation class at one of three hospital sites
- Participants had to be over 18
Key exclusion criteria (1 listed)
- Unable to read and understand English information sheet and consent form
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychological Intervention SessionOne-off session aimed at changing participants beliefs around illness control and consequences, applied using a motivational interviewing style. | Behavioural | – |
Primary outcome
CR Adherence
Time frame: Approximately 3-months after recruitment
Number of cardiac rehabilitation classes attended in total.
1 secondary outcome
Illness Perceptions Questionnaire-Revised Scores
Time frame: 3-months after consent
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2010.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gavin H Taylor, MA (Hons) principal investigator
NHS Greater Glasgow and Clyde
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychological Intervention Session in people with Cardiac Rehabilitation, run by NHS Greater Glasgow and Clyde at 3 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 May 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CR Adherence (time frame: Approximately 3-months after recruitment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2010; AzTrials last refreshed its copy on 3 Nov 2026.