Plain English Summary
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)
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Effectiveness of theory based interventions to improve attendance at cardiac rehabilitation: a randomized controlled trial
Acronym
Study hypothesis
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
Grampian Research Ethics Committee,17/11/2006, ref: 06/S0802/119
Study design
2x2 factorial design single centre blind randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Phase III
Drug names
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 trial start date
01/01/2007
Overall trial end date
31/12/2008
Reason abandoned (if study stopped)
Eligibility
Participant 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.
Participant type
Patient
Age group
Adult
Gender
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)
Participant 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
Recruitment start date
01/01/2007
Recruitment end date
31/12/2008
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University of Aberdeen
Aberdeen
AB25 2ZD
United Kingdom
Sponsor information
Organisation
University of Aberdeen (UK)
Sponsor details
Research and Innovation
University of Aberdeen
King's College
Aberdeen
AB24 3FX
United Kingdom
+44 (0)1224 272000
res-innov@abdn.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
University of Aberdeen
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
Universities (academic only)
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2009 results in: http://www.ncbi.nlm.nih.gov/pubmed/19303364