Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Changing illness perceptions of patients with intermittent claudication: a pilot randomised controlled trial to increase walking
Acronym
Study hypothesis
Principal research question:
Will a brief psychological intervention to modify illness perceptions increase walking behaviour for patients with intermittent claudication?
Secondary research questions:
1. Will a brief psychological intervention increase intention to walk?
2. Will a brief psychological intervention increase walking self-efficacy?
3. Will a brief psychological intervention change illness perceptions?
As of 03/11/2009 this record was updated to include an extended anticipated end date; the initial anticipated end date at the time of registration was 01/10/2009.
As of 13/01/2010 this record was updated to include a further extended anticipated end date; the previous anticipated end date at the time of registration was 30/11/2009.
Ethics approval
Fife and Forth Valley NHS Research Ethics Committee approved on the 12th February 2008 (ref: 08/S0501/6).
Study design
Single-centre randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Quality of life
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Intermittent claudication
Intervention
Session 1: one hour in the participant's own home:
1. Modify illness beliefs regarding interpretation of symptoms and chronicity of disease by providing information about disease, and behaviour health link
2. Modify understanding of consequences of disease and future health risk perception by providing information on consequences of disease
3. Operationalise above points 1 and 2 using motivational interviewing
Session 2: one hour in the participant's own home:
4. Improve personal control/self efficacy by prompting specific goal setting for walking; prompt barrier identification to formulate a coping plan
Three follow up phone calls (monthly):
5. Prompt review of behavioural goals through monthly phone calls
6. Provide social support through the inclusion in the intervention of a key partner
Control:
Control group receives usual care and phone calls to minimise social support effects.
Total duration of treatment is 2 hours. Follow-up for both arms is at 4 months, however an amendment to ethical approval has been submitted to carry out long-term follow-ups at 1 year and 2 years after recruitment.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Increase in walking behaviour as measured by pedometer (mean daily steps measured over 1 week at each time point) at baseline, 4 months, and 1 year and 2 years (subject to the approval of the amendment).
Secondary outcome measures
All outcomes will be measured at baseline, 4 months, and 1 year and 2 years (subject to the approval of the amendment):
1. Self-report physical activity, measured with the International Physical Activity Questionnaire (IPAQ)
2. Quality of life, measured with the Intermittent Claudication Questionnaire (ICQ)
3. Psychological outcomes, measured with a range of psychological questionnaires adapted for use in this study
4. Clinical outcome, measured by type of treatment received or scheduled by each time point e.g. angioplasty, bypass graft, conservative treatment
Overall trial start date
07/04/2008
Overall trial end date
01/02/2012
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Newly diagnosed patients with intermittent claudication
2. English speaking
3. Aged over 55 years, either sex
Participant type
Patient
Age group
Other
Gender
Both
Target number of participants
80
Participant exclusion criteria
1. Severe cardiac disease
2. Patients unable to perform simple exercise test at slow speed
3. Severe debility, e.g., arthritis
4. History of orthopaedic surgery
5. Ankle Brachial Blood Pressure Index (ABPI) at diagnosis of less than 0.35
Recruitment start date
07/04/2008
Recruitment end date
01/02/2012
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Psychology Department
Stirling
FK9 4LA
United Kingdom
Sponsor information
Organisation
University of Stirling (UK)
Sponsor details
Head of Psychology Department
Psychology Department
Stirling
FK9 4LA
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
University of Stirling (UK) - Internally funded PhD
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
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
1. 2010 protocol in http://www.ncbi.nlm.nih.gov/pubmed/20929555
2. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22038532
3. 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23468185
Publication citations
-
Protocol
Cunningham MA, Swanson V, O'Carroll RE, Holdsworth RJ, Increasing walking in patients with intermittent claudication: protocol for a randomised controlled trial., BMC Cardiovasc Disord, 2010, 10, 49, doi: 10.1186/1471-2261-10-49.
-
Results
Cunningham MA, Swanson V, O'Carroll RE, O'Caroll RE, Holdsworth RJ, Randomized clinical trial of a brief psychological intervention to increase walking in patients with intermittent claudication., Br J Surg, 2012, 99, 1, 49-56, doi: 10.1002/bjs.7714.
-
Results
Cunningham MA, Swanson V, Holdsworth RJ, O'Carroll RE, Late effects of a brief psychological intervention in patients with intermittent claudication in a randomized clinical trial., Br J Surg, 2013, 100, 6, 756-760, doi: 10.1002/bjs.9100.