Condition category
Nutritional, Metabolic, Endocrine
Date applied
18/06/2010
Date assigned
18/06/2010
Last edited
29/08/2013
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

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

http://www.bris.ac.uk/

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

  1. 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.

Additional files

Editorial Notes