Topic: Diabetes Research Network
Conditions
Interventions
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 comprise
Sponsors
University of Bristol (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
Exclusion criteria: Patients diagnosed with charcot foot
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the feasibility and acceptability of the psychological intervention, measured in December 2010 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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) | — |
Countries
United Kingdom
Outcome results
None listed