Enhancing SKIN Health and Safety in Aged CARE: An Exploratory Cluster Randomized Pragmatic Trial in Aged Nursing Home Residents (SKINCARE)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 405
- 试验地点
- 4
- 主要终点
- Location of Pressure Ulcers (PU) Category II, III, IV, Unstageable, Deep Tissue Injury (DTI)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- •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
结局指标
主要结局
Location of Pressure Ulcers (PU) Category II, III, IV, Unstageable, Deep Tissue Injury (DTI)
时间窗: Week 24 +/- 1
Classification according to NPUAP (National Pressure Ulcer Advisory Panel)/EPUAP (European Pressure Ulcer Advisory Panel) 2014
Incidence of Incontinence-associated Dermatitis (IAD)
时间窗: Week 24 +/- 1
Proportions of newly developed IAD per person and per skin area to calculate the cumulative incidence. The classification of IAD will be according to GLOBIAD (Ghent Global IAD Categorisation tool) and distinction between intact and eroded skin according to Proceedings of the Global IAD Expert Panel.
Incidence of Skin Tears (ST)
时间窗: Week 24 ± 1
Proportions of newly developed STs per person and skin area to calculate the cumulative incidence. Classification according to ISTAP (International Skin Tear Advisory Panel).
Incidence of Intertrigo
时间窗: Week 24 ± 1
Proportions of newly developed intertrigo per person and skin area to calculate the cumulative incidence. Medical diagnoses according to ICD (international code of diseases) 11.
Incidence of Pressure Ulcers (PU) Category II, III, IV, Unstageable, Deep Tissue Injury (DTI)
时间窗: Week 24 +/- 1
Proportions of newly developed PUs per person and per skin area to calculate the cumulative incidence
次要结局
- Quality of Life (QoL) (residents without cognitive impairment): WHO-Five Well-being Index (WHO = World Health Organization)(Week 0, Week 24 ± 1)
- Skin surface temperature [°C] on right lower leg lateral, right midvolar forearm(Week 0, Week 12 ± 1, Week 24 ± 1)
- Stratum Corneum Hydration (SCH) measurements on right lower leg lateral, right midvolar forearm(Week 0, Week 12 ± 1, Week 24 ± 1)
- Quality of Life (QoL) (cognitively impaired residents): QUALIDEM 37-Item Assessment(Week 0, Week 24 ± 1)
- Pain Assessment (cognitively impaired residents): Verbal rating scale(Week 0, Week 12 ± 1, Week 24 ± 1)
- Overall Dry Skin Score (ODS) on face, trunk, arms, hands, feet, legs(Week 0, Week 12 ± 1, Week 24 ± 1)
- Skin Surface pH on right lower leg lateral, right midvolar forearm(Week 0, Week 12 ± 1, Week 24 ± 1)
- 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)(Week 0, Week 24 ± 1)
- Transepidermal Water Loss (TEWL) on right lower leg lateral, right midvolar forearm(Week 0, Week 12 ± 1, Week 24 ± 1)
- Itch Assessment(Week 0, Week 12 ± 1, Week 24 ± 1)
- Pain Assessment (residents without cognitive impairment): numeric rating scale(Week 0, Week 12 ± 1, Week 24 ± 1)
- Assesment of dementia: Global Deterioration scale.(Week 0)
研究者
PD Dr. Jan Kottner
Scientific Director Clinical Research Center for Hair and Skin Science
Charite University, Berlin, Germany