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23 February 2012
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| [ Print-friendly version ] |
| Changing illness perceptions of patients with intermittent claudication |
| ISRCTN | ISRCTN28051878 |
| ClinicalTrials.gov identifier | |
| Public title | Changing illness perceptions of patients with intermittent claudication |
| Scientific title | Changing illness perceptions of patients with intermittent claudication: a pilot randomised controlled trial to increase walking |
| Acronym | N/A |
| Serial number at source | N/A |
| 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. |
| Lay summary | Not provided at time of registration |
| 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 |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Intermittent claudication |
| Participants - inclusion criteria |
1. Newly diagnosed patients with intermittent claudication
2. English speaking 3. Aged over 55 years, either sex |
| Participants - 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 |
| Anticipated start date | 07/04/2008 |
| Anticipated end date | 01/02/2012 |
| Status of trial | Completed |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | 80 |
| Interventions |
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. |
| 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). |
| 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 |
| Sources of funding | University of Stirling (UK) - Internally funded PhD |
| Trial website | |
| Publications |
1. 2010 protocol in http://www.ncbi.nlm.nih.gov/pubmed/20929555
2. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22038532 |
| Contact name | Ms Margaret Cunningham |
| Address |
Psychology Department
University of Stirling |
| City/town | Stirling |
| Zip/Postcode | FK9 4LA |
| Country | United Kingdom |
| Sponsor | University of Stirling (UK) |
| Address |
Head of Psychology Department
Psychology Department |
| City/town | Stirling |
| Zip/Postcode | FK9 4LA |
| Country | United Kingdom |
| Sponsor website: | http://www.stir.ac.uk/ |
| Date applied | 01/04/2008 |
| Last edited | 25/01/2012 |
| Date ISRCTN assigned | 28/10/2009 |
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| © 2012 ISRCTN unless otherwise stated. | |
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