Changing illness perceptions of patients with intermittent claudication

ISRCTN	ISRCTN28051878
DOI	https://doi.org/10.1186/ISRCTN28051878
Protocol serial number	N/A
Sponsor	University of Stirling (UK)
Funder	University of Stirling (UK) - Internally funded PhD

Submission date: 01/04/2008
Registration date: 28/10/2009
Last edited: 28/05/2013

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Ms Margaret Cunningham
Scientific

Psychology Department
University of Stirling
Stirling
FK9 4LA
United Kingdom

Study information

Primary study design	Interventional
Study design	Single-centre randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Changing illness perceptions of patients with intermittent claudication: a pilot randomised controlled trial to increase walking
Study objectives	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(s)	Fife and Forth Valley NHS Research Ethics Committee approved on the 12th February 2008 (ref: 08/S0501/6).
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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).
Key secondary outcome measure(s)	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
Completion date	01/02/2012

Eligibility

Participant type(s)	Patient
Age group	Other
Sex	All
Target sample size at registration	80
Key inclusion criteria	1. Newly diagnosed patients with intermittent claudication 2. English speaking 3. Aged over 55 years, either sex
Key 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
Date of first enrolment	07/04/2008
Date of final enrolment	01/02/2012

Locations

Countries of recruitment

United Kingdom
Scotland

Study participating centre

Psychology Department

Stirling
FK9 4LA
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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	01/01/2012		Yes	No
Results article	results	01/05/2013		Yes	No
Protocol article	protocol	07/10/2010		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes