Clinical trial NCT03824886: Enhancing SKIN Health and Safety in Aged CARE
Official title: Enhancing SKIN Health and Safety in Aged CARE: An Exploratory Cluster Randomized Pragmatic Trial in Aged Nursing Home Residents (SKINCARE)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Xerosis Cutis
Dry Skin
Pruritus
Pressure Ulcer
Intertrigo
Incontinence-associated Dermatitis
Skin Tear
Skin Care
Keywords: Skin Integrity
Aged Care Receivers
Care Dependent
Geriatric Patients
Prevention
Skin Protection
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2019-01-31
Enrollment: 405
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: Inclusion/ Exclusion Criteria for Residents:

Inclusion Criteria:

* Living in the nursing home,
* 65+ years,
* 'Care degree 2' or higher according to SGB XI (Sozialgesetzbuch (Codebook of Social Law)),
* Written informed consent (by legal representative if required)

Exclusion Criteria:

* Residents at end of life,
* Any dermatological condition or skin affection requiring dermatological treatment,
* Known allergies to any product ingredients

Inclusion/ Exclusion Criteria for Nursing Homes:

Inclusion Criteria:

* Nursing home in the federal state of Berlin with at least n = 70 or more residents.
* Expression of a clear commitment to implement the skin care algorithm if assigned to the intervention group,
* Valid pressure ulcer prevention standard/algorithm is in place,
* Written commitment to adherence to the trial procedures regardless of the outcome of randomisation. Exclusion criteria:
* Nursing homes with less than n = 70 residents in the federal state of Berlin.

Exclusion Criteria:

* Nursing homes with less than n = 70 residents in the federal state of Berlin

Primary outcomes:
measure: Incidence of Pressure Ulcers (PU) Category II, III, IV, Unstageable, Deep Tissue Injury (DTI)
timeFrame: Week 12 +/- 1
measure: Incidence of Pressure Ulcers (PU) Category II, III, IV, Unstageable, Deep Tissue Injury (DTI)
timeFrame: Week 24 +/- 1
measure: Location of Pressure Ulcers (PU) Category II, III, IV, Unstageable, Deep Tissue Injury (DTI)
timeFrame: Week 12 +/- 1
measure: Location of Pressure Ulcers (PU) Category II, III, IV, Unstageable, Deep Tissue Injury (DTI)
timeFrame: Week 24 +/- 1
measure: Incidence of Incontinence-associated Dermatitis (IAD)
timeFrame: Week 12 +/- 1
measure: Incidence of Incontinence-associated Dermatitis (IAD)
timeFrame: Week 24 +/- 1
measure: Incidence of Intertrigo
timeFrame: Week 12 ± 1
measure: Incidence of Intertrigo
timeFrame: Week 24 ± 1
measure: Incidence of Skin Tears (ST)
timeFrame: Week 12 ± 1
measure: Incidence of Skin Tears (ST)
timeFrame: Week 24 ± 1
Secondary outcomes:
measure: Overall Dry Skin Score (ODS) on face, trunk, arms, hands, feet, legs
timeFrame: Week 0, Week 12 ± 1, Week 24 ± 1
measure: Stratum Corneum Hydration (SCH) measurements on right lower leg lateral, right midvolar forearm
timeFrame: Week 0, Week 12 ± 1, Week 24 ± 1
measure: Transepidermal Water Loss (TEWL) on right lower leg lateral, right midvolar forearm
timeFrame: Week 0, Week 12 ± 1, Week 24 ± 1
measure: Skin Surface pH on right lower leg lateral, right midvolar forearm
timeFrame: Week 0, Week 12 ± 1, Week 24 ± 1
measure: Skin surface temperature [°C] on right lower leg lateral, right midvolar forearm
timeFrame: Week 0, Week 12 ± 1, Week 24 ± 1
measure: Quality of Life (QoL) (residents without cognitive impairment): WHO-Five Well-being Index (WHO = World Health Organization)
timeFrame: Week 0, Week 24 ± 1
measure: Quality of Life (QoL) (cognitively impaired residents): QUALIDEM 18-Item Assessment (QUALIDEM = No original term, measurement instrument for proxy rating of quality of life in people with dementia)
timeFrame: Week 0, Week 24 ± 1
measure: Quality of Life (QoL) (cognitively impaired residents): QUALIDEM 37-Item Assessment
timeFrame: Week 0, Week 24 ± 1
measure: Itch Assessment
timeFrame: Week 0, Week 12 ± 1, Week 24 ± 1
measure: Pain Assessment (residents without cognitive impairment): numeric rating scale
timeFrame: Week 0, Week 12 ± 1, Week 24 ± 1
measure: Pain Assessment (cognitively impaired residents): Verbal rating scale
timeFrame: Week 0, Week 12 ± 1, Week 24 ± 1
measure: Assesment of dementia: Global Deterioration scale.
timeFrame: Week 0
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin Berlin
city: Berlin
country: Germany
facility: Charité-Universitätsmedizin Berlin
Study officials:
affiliation: Charite University, Berlin, Germany
name: Jan Kottner, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kottner J, Hahnel E, El Genedy M, Neumann K, Balzer K. Enhancing SKIN health and safety in aged CARE (SKINCARE Trial): a study protocol for an exploratory cluster-randomized pragmatic trial. Trials. 2019 May 29;20(1):302. doi: 10.1186/s13063-019-3375-7.