Topic: Primary Care Research Network for England, Generic Health Relevance and Cross Cutting Themes
Conditions
Interventions
Participants in the intervention group will be asked to wear the protective socks during their waking hours every day for a period of 16 weeks, starting from the morning following the day they sign co
Sponsors
Royal Devon and Exeter Foundation Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 17/06/2014: 1. Resident in a care home or living in the community and taking steroids for at least a month 2. Aged 65 years or older 3. Ambulatory and/or wheelchair user able to take part in normal day-to-day activities Previous inclusion criteria: 1. Resident in a care home 2. Male and female aged 18 years or older, upper age limit 100 years 3. Ambulatory and/or wheelchair user able to take part in daily activities within the care home 4. Having a past medical history of skin tear injuries to legs defined as any reported skin tear injury, regardless of severity, which has occurred within 12 months prior to recruitment
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 17/06/2014: 1. Not competent to give informed consent or complete study questionnaires 2. Bedbound 3. Undergoing current treatment for lacerations or ulcers on legs 4. Use of graduated compression stockings/bandaging 5. Scheduled to be admitted to hospital for elective surgery during the study period 6. A participant in other concurrent interventional research which may over-burden the participant or confound data collection Previous exclusion criteria: 1. Not competent to give informed consent in the opinion of the recruiting nurse 2. Life expectancy less than 6 months 3. Resident is bedbound 4. Resident is being treated for current lacerations or ulcers on their legs 5. Resident is likely to use graduated compression stockings or similar during the intervention period 6. Resident is scheduled to be admitted to hospital for elective surgery during the 16-week trial period 7. Resident is a participant in other concurrent interventional research which may over-burden the resident or confound data collection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Skin tear-free days: this is the number of days that a participant is free of any skin tears to the lower legs/112 days. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome measures: 1. Skin lacerations measured (length, breadth and area), and graded to Payne-Martin categories or STAR Skin Tear Classification System 2. Standardised measure of health status (EQ-5D-5L) 3. Disease-specific quality of life measured by Cardiff Wound Impact Schedule 4. Assessment of capability (ICECAP-O) 5. Assessment of fear of falling (Short FES-I) 6. Adverse events caused by the socks 7. Health care resource use The outcome measures for the current pilot/feasibility study are: 1. Recruitment rate for homes 2. Proportion of participants (home residents) eligible 3. Recruitment rate for participants 4. Attrition and loss to follow up 5. Ascertainment of injuries 6. Completion and completeness of study questionnaires 7. Evaluation of skin-tear classification systems 8. Estimates of the distribution of outcome measures 9. Feasibility of the workload 10. Acceptability of the intervention to participants 11. Acceptability of study participation to participants | — |
Countries
United Kingdom
Outcome results
None listed