Improving attendance at cardiac rehabilitation: a randomized controlled trial
| ISRCTN | ISRCTN12160517 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12160517 |
| Secondary identifying numbers | N/A |
- Submission date
- 06/07/2011
- Registration date
- 08/08/2011
- Last edited
- 10/02/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
Background and study aims
Phase III cardiac rehabilitation is a program of supervised exercise, relaxation and education for people with heart disease. It improves fitness and reduces the likelihood of future heart attacks, but attendance rates are low. We set out to increase the proportion of people attending cardiac rehabilitation using a specially designed invitation letter and supportive leaflet, using wording that theoretically should encourage people to attend.
Who can participate?
People were recruited to the study while in hospital following a heart attack or heart surgery.
What does the study involve?
Participants are randomly allocated to either receive either the new letter or the previously used letter. Similarly, participants are randomly allocated to receive the new leaflet or not. We then count how many of each group attend cardiac rehabilitation.
What are the possible benefits and risks of participating?
There were no risks to participants.
Where is the study run from?
Aberdeen Royal Infirmary (UK)
When is the study starting and how long is it expected to run for?
January 2007 to December 2008
Who is funding the study?
University of Aberdeen (UK)
Who is the main contact?
During the study: Dr Sultan Mosleh (s.m.mosleh@abdn.ac.uk)
After study completion: Dr Neil Campbell (n.campbell@abdn.ac.uk)
Contact information
Scientific
University of Aberdeen
Centre of Academic Primary Care
Polwarth Building
Foresterhill
Aberdeen
AB25 2ZD
United Kingdom
Study information
| Study design | 2x2 factorial design single centre blind randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Effectiveness of theory based interventions to improve attendance at cardiac rehabilitation: a randomized controlled trial |
| Study objectives | A theory-based invitation letter and leaflet will increase attendance at phase III cardiac rehabilitation above that attained by the usual invitation letter |
| Ethics approval(s) | Grampian Research Ethics Committee,17/11/2006, ref: 06/S0802/119 |
| Health condition(s) or problem(s) studied | Coronary heart disease. Specifically post myocardial infarction and post cardiac surgery. |
| Intervention | 1. Letter of invitation to cardiac rehabilitation designed with theory based wording 2. Supportive leaflet to accompany letter of invitation to cardiac rehabilitation designed with theory based wording 3. The control was the previously used letter of invitation to cardiac rehabilitation |
| Intervention type | Other |
| Primary outcome measure | Attendance at least one session of a Phase III CR programme |
| Secondary outcome measures | 1. To identify the factors associated with CR attendance 2. The independent measures of CR attendance were determined by a baseline self-report questionnaire which covered socio-demographical and medical factors, Hospital Anxiety and Depression Scale (HAD) (Zigmond and Snaith, 1983), Theory of Planned Behaviour (TPB) scale (Blanchard et al, 2002; Blanchard et al, 2003) and Illness Perception questionnaire (Weinman et al. 1996) |
| Overall study start date | 01/01/2007 |
| Completion date | 31/12/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 412 patients were required in total to enable comparison between all of the four cells, or 206 to enable two-group comparisons (theoretical letter vs. the standard letter, or leaflet vs. no leaflet) |
| Key inclusion criteria | Consecutive patients who were admitted with myocardial infarction (MI) or post cardiac surgery between January 2007 and December 2007 at Aberdeen Royal Infirmary were invited to participate in the study if they were referred to the cardiac rehabilitation (CR) programme in the city of Aberdeen or the area of Aberdeenshire. |
| Key exclusion criteria | 1. Patients who had not had MI 2. Patients who were terminally ill 3. Patients who had cardiac valve stenosis 4. Patients who had arrhythmia 5. Patients who abuse alcohol or drugs 6. Patients who are mentally or physically disabled 7. Those referred to the CR programme from out of Aberdeen area |
| Date of first enrolment | 01/01/2007 |
| Date of final enrolment | 31/12/2008 |
Locations
Countries of recruitment
- Scotland
- United Kingdom
Study participating centre
AB25 2ZD
United Kingdom
Sponsor information
University/education
Research and Innovation
University of Aberdeen
King's College
Aberdeen
AB24 3FX
Scotland
United Kingdom
| Phone | +44 (0)1224 272000 |
|---|---|
| res-innov@abdn.ac.uk | |
| Website | http://www.abdn.ac.uk/ |
"ROR" |
https://ror.org/016476m91 |
Funders
Funder type
University/education
Private sector organisation / Universities (academic only)
- Alternative name(s)
- ABDN
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/09/2009 | Yes | No |
Editorial Notes
10/02/2016: Plain English summary added.
30/11/2015: Publication reference added.
