Trials / Completed
CompletedNCT03824886
Enhancing SKIN Health and Safety in Aged CARE
Enhancing SKIN Health and Safety in Aged CARE: An Exploratory Cluster Randomized Pragmatic Trial in Aged Nursing Home Residents (SKINCARE)
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 405 (actual)
- Sponsor
- PD Dr. Jan Kottner · Academic / Other
- Sex
- All
- Age
- 65 Years
- Healthy volunteers
- Accepted
Summary
Aged long-term care receivers are affected by various adverse skin conditions like pressure ulcers, incontinence-associated dermatitis, dryness, intertrigo and many more. Prevention of these skin problems and the provision of general hygiene and skin care activities are key areas of nursing practice. Numerous condition specific guidelines are available and are implemented separately. The more guidelines exist, the more difficult it is for nurses to implement them all. On the other hand, there is a huge overlap in terms of aetiology, pathogenesis and prevention of aforementioned skin conditions. The overall aim of this trial is to test the feasibility and to estimate possible effects of a comprehensive skin care package targeting main nursing relevant skin problems at the same time. Therefore a study will be performed in nursing homes of the state of Berlin comparing the skin care package to standard care. Residents' safety and subjective wellbeing will increase combined with improvements in professional competence of nurses. An advisory board consisting of international experts agreed already to supervise the trial.
Detailed description
Objectives and aims: Aged and care dependent patients suffer from many adverse skin conditions like xerosis cutis (including pruritus), pressure ulcers, skin tears, intertrigo and incontinence-associated dermatitis. Separate preventive strategies for these particular risks and diseases are available and partly implemented. Although distinct clinical diagnoses, there are substantial overlaps in terms of etiology (e.g. skin fragility, immobility) pathophysiology, prevention (e.g. safe handling, off-loading) and treatment (e.g. skin protection and care). Facilities are challenged to implement fragmented, condition-specific guidelines, neglecting shared etiologies and prevention and treatment principles, which has been shown to be an important barrier for implementation of evidence-based practice. Recently an evidence-based comprehensive skin care algorithm was developed. The objective of this trial is to investigate the feasibility of the implementation of this skin care package, to describe context factors for implementation, to estimate effect sizes and intracluster coefficients. Study design: An exploratory cluster randomized trial in aged nursing home residents will be conducted. The cluster design was chosen to avoid contamination between groups. A total of n = 500 residents from n = 20 nursing homes (randomly selected from the population of nursing homes of the state of Berlin) will be included in the study. In the intervention group (n = 10 nursing homes), the developed evidence-based algorithm will be implemented. The control group (n = 10 nursing homes) receives the usual standard care of the respective nursing home.
Conditions
- Xerosis Cutis
- Dry Skin
- Pruritus
- Pressure Ulcer
- Intertrigo
- Incontinence-associated Dermatitis
- Skin Tear
- Skin Care
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Implementation of skin care algorithm | Implementation of structured and standardized skin care regimen |
Timeline
- Start date
- 2018-10-01
- Primary completion
- 2021-06-04
- Completion
- 2021-06-04
- First posted
- 2019-01-31
- Last updated
- 2021-08-09
Locations
2 sites across 1 country: Germany
Source: ClinicalTrials.gov record NCT03824886. Inclusion in this directory is not an endorsement.