Changing illness perceptions of patients with intermittent claudication
| ISRCTN | ISRCTN28051878 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN28051878 |
| Secondary identifying numbers | N/A |
- 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
Scientific
Psychology Department
University of Stirling
Stirling
FK9 4LA
United Kingdom
Study information
| Study design | Single-centre randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 | 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 study start date | 07/04/2008 |
| Completion date | 01/02/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Other |
| Sex | Both |
| Target number of participants | 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
- Scotland
- United Kingdom
Study participating centre
Psychology Department
Stirling
FK9 4LA
United Kingdom
FK9 4LA
United Kingdom
Sponsor information
University of Stirling (UK)
University/education
University/education
Head of Psychology Department
Psychology Department
Stirling
FK9 4LA
Scotland
United Kingdom
| Website | http://www.stir.ac.uk/ |
|---|---|
"ROR" |
https://ror.org/045wgfr59 |
Funders
Funder type
University/education
University of Stirling (UK) - Internally funded PhD
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 07/10/2010 | Yes | No | |
| Results article | results | 01/01/2012 | Yes | No | |
| Results article | results | 01/05/2013 | Yes | No |
