Contact information
Type
Scientific
Primary contact
Dr Angela Beattie
ORCID ID
Contact details
Department of Social Medicine
Canynge Hall
Whiteladies Road
Bristol
BS8 2PR
United Kingdom
Angela.Beattie@bristol.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
6299
Study information
Scientific title
Development of a cognitive-behavioural intervention to reduce the risk of foot re-ulceration in patients with diabetes
Acronym
DRN 279
Study hypothesis
This is a phase 1 and 2 feasibility study which aims to develop a psychological intervention for people with diabetes. The aim is to delay or prevent the onset of further diabetic foot ulcers recurring. Phase 1 involves a qualitative design incorporating 15 interviews and one patient focus group. Phase 2 involves the exploratory trial.
Ethics approval
Frenchay Research Ethics Committee approved on the 19th December 2007 (ref: 07/HO107/62)
Study design
Single centre randomised interventional prevention and process of care trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Prevention
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Topic: Diabetes Research Network; Diabetic Foot Ulcer Subtopic: Both; Disease: Diabetic Control
Intervention
To deliver a psychological intervention which seeks to modify coping and manage emotional distress in order to reduce the risk of reulceration. This exploratory randomised controlled trial is comprised of two groups:
1. Intervention: receive CBT intervention
2. Control: receive usual care
Total duration of intervention: 13 weeks
Follow up length: anticipated to last up to 6 months (subject to funding extension)
Study entry: single randomisation only
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
To assess the feasibility and acceptability of the psychological intervention, measured in December 2010
Secondary outcome measures
To assess the feasibility and acceptability of the psychological intervention using:
1. Hospital Anxiety and Depression Score (HADS; 0 = not at all to 3 = most of the
time)
2. Medical and Coping Modes Questionnaire (MCMQ; 1 = very much to 4 = very little)
3. Brief Illness Perception Questionnaire (BIPQ; 0 = no affect to 10 = severely affects life)
4. Profile of Mood States (POMS; 0 = not at all to 4 = extremely)
5. Work and Social Adjustment Scale (WSAS)
6. Generalised Anxiety Disorder Questionnaire (GAD-IV; 0 = no, 1 = yes)
7. 12-item short form health survey (SF-12; 1 = excellent to 5 = very poor)
8. EQ-5D (1 = no problems to 3 unable to perform usual activities)
9. Embarrassment Questionnaire (EMB-Q; 1 = strongly disagree to 5 = strongly agree)
10. Social Support Questionnaire (SSQ; 1 = never to 7 = always)
Overall trial start date
10/02/2009
Overall trial end date
19/04/2010
Reason abandoned
Eligibility
Participant inclusion criteria
1. Patients with one or more previous ulcer, but ulcer free at the time of recruitment
2. Aged 49 - 88 years, either sex
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned sample size: 30; UK sample size: 30
Participant exclusion criteria
Patients diagnosed with charcot foot
Recruitment start date
10/02/2009
Recruitment end date
19/04/2010
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Social Medicine
Bristol
BS8 2PR
United Kingdom
Sponsor information
Organisation
University of Bristol (UK)
Sponsor details
Research & Enterprise Development
Senate House
Tyndall Avenue
Bristol
BS8 1TH
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB) programme (ref: PB-PG-0906-11179)
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
2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/22459731
Publication citations
-
Results
Vedhara K, Beattie A, Metcalfe C, Roche S, Weinman J, Cullum N, Price P, Dayan C, Cooper AR, Campbell R, Chalder T, Development and preliminary evaluation of a psychosocial intervention for modifying psychosocial risk factors associated with foot re-ulceration in diabetes., Behav Res Ther, 2012, 50, 5, 323-332, doi: 10.1016/j.brat.2012.02.013.