Condition category
Circulatory System
Date applied
06/07/2011
Date assigned
08/08/2011
Last edited
10/02/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Contact information

Type

Scientific

Primary contact

Dr Sultan Mosleh

ORCID ID

Contact details

University of Aberdeen
Centre of Academic Primary Care
Polwarth Building
Foresterhill
Aberdeen
AB25 2ZD
United Kingdom

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 measures

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

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

http://www.abdn.ac.uk/

Funders

Funder type

University/education

Funder name

University of Aberdeen

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

academic

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

Results - basic reporting

Publication summary

2009 results in: http://www.ncbi.nlm.nih.gov/pubmed/19303364

Publication citations

Additional files

Editorial Notes

10/02/2016: Plain English summary added. 30/11/2015: Publication reference added.