Condition category
Circulatory System
Date applied
01/04/2008
Date assigned
28/10/2009
Last edited
28/05/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Ms Margaret Cunningham

ORCID ID

Contact details

Psychology Department
University of Stirling
Stirling
FK9 4LA
United Kingdom

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 measures

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

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

http://www.stir.ac.uk/

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

Results - basic reporting

Publication summary

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

  1. 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.

  2. 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.

  3. 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.

Additional files

Editorial Notes