Enhancing SKIN Health and Safety in Aged CARE (SKINCARE)

August 6, 2021 updated by: PD Dr. Jan Kottner

Enhancing SKIN Health and Safety in Aged CARE: An Exploratory Cluster Randomized Pragmatic Trial in Aged Nursing Home Residents (SKINCARE)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

405

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 10117
        • Charité - Universitätsmedizin Berlin
      • Berlin, Germany, 10117
        • Charite-Universitatsmedizin Berlin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Implementation of skin care algorithm
In the interventional nursing homes, a structured skin care prevention package based on a newly developed evidence-based skin care algorithm will be implemented at the nursing homes and delivered by nurses.
Other: Implementation of skin care algorithm
Implementation of structured and standardized skin care regimen
No Intervention: Standard Care
In the control group, no additional intervention will be implemented. PU and IAD prevention and basic hygiene and skin care activities are routinely conducted in German nursing homes. This is considered as 'usual practice'.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Pressure Ulcers (PU) Category II, III, IV, Unstageable, Deep Tissue Injury (DTI)
Time Frame: Week 12 +/- 1
Proportions of newly developed PUs per person and per skin area to calculate the cumulative incidence
Week 12 +/- 1
Incidence of Pressure Ulcers (PU) Category II, III, IV, Unstageable, Deep Tissue Injury (DTI)
Time Frame: Week 24 +/- 1
Proportions of newly developed PUs per person and per skin area to calculate the cumulative incidence
Week 24 +/- 1
Location of Pressure Ulcers (PU) Category II, III, IV, Unstageable, Deep Tissue Injury (DTI)
Time Frame: Week 12 +/- 1
Classification according to NPUAP (National Pressure Ulcer Advisory Panel)/EPUAP (European Pressure Ulcer Advisory Panel) 2014
Week 12 +/- 1
Location of Pressure Ulcers (PU) Category II, III, IV, Unstageable, Deep Tissue Injury (DTI)
Time Frame: Week 24 +/- 1
Classification according to NPUAP (National Pressure Ulcer Advisory Panel)/EPUAP (European Pressure Ulcer Advisory Panel) 2014
Week 24 +/- 1
Incidence of Incontinence-associated Dermatitis (IAD)
Time Frame: Week 12 +/- 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.
Week 12 +/- 1
Incidence of Incontinence-associated Dermatitis (IAD)
Time Frame: 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.
Week 24 +/- 1
Incidence of Intertrigo
Time Frame: Week 12 ± 1
Proportions of newly developed intertrigo per person and skin area to calculate the cumulative incidence. Medical diagnoses according to ICD (international classification of diseases) 11.
Week 12 ± 1
Incidence of Intertrigo
Time Frame: 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.
Week 24 ± 1
Incidence of Skin Tears (ST)
Time Frame: Week 12 ± 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).
Week 12 ± 1
Incidence of Skin Tears (ST)
Time Frame: 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).
Week 24 ± 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Dry Skin Score (ODS) on face, trunk, arms, hands, feet, legs
Time Frame: Week 0, Week 12 ± 1, Week 24 ± 1
Change in Overall Dry Skin score. ODS is a clinical assessment of the presence and severity of skin dryness using a five-point scale. A score of '0' indicates no skin dryness, whereas a score of '4' indicates advanced skin roughness, large scales, inflammation and cracks.
Week 0, Week 12 ± 1, Week 24 ± 1
Stratum Corneum Hydration (SCH) measurements on right lower leg lateral, right midvolar forearm
Time Frame: Week 0, Week 12 ± 1, Week 24 ± 1

Change in Stratum Corneum Hydration. SCH was measured using the Corneometer CM 825 (Courage + Khazaka, Cologne, Germany). This measurement is based on the differences of the dielectric constant of water and other substances. With this device, only the moisture content in the stratum corneum is measured. The arbitrary units (a.u.) range from 0 to 120 where as higher readings indicate higher stratum corneum hydration.

  • Means of triplicate measurements per skin area in arbitrary units at right lower leg lateral, right midvolar forearm
  • If measurements are not possible at right leg/arm (e.g. due to amputation) they will be conducted at contralateral skin areas
Week 0, Week 12 ± 1, Week 24 ± 1
Transepidermal Water Loss (TEWL) on right lower leg lateral, right midvolar forearm
Time Frame: Week 0, Week 12 ± 1, Week 24 ± 1

Change in Transepidermal water loss. TEWL was measured with the Tewameter TM 300 (Courage + Khazaka, Cologne, Germany). The probe captures the constant permeation of water through the stratum corneum in gram per hour per m2. The measuring probe contains a pair of sensors that are located in different distances to the skin surface to determine temperature and relative humidity above the skin surface. The humidity gradient between both sensors is used for calculating the transepidermal water loss. Higher values indicate a higher transepidermal water loss.

  • Means of duplicate measurements per skin area in g/m2/h at right lower leg lateral, right midvolar forearm
  • If measurements are not possible at right leg/arm (e.g. due to amputation) they will be conducted at contralateral skin areas
Week 0, Week 12 ± 1, Week 24 ± 1
Skin Surface pH on right lower leg lateral, right midvolar forearm
Time Frame: Week 0, Week 12 ± 1, Week 24 ± 1

Change in Skin surface pH. Skin surface pH was measured with the Skin-pH-Meter PH 905 (Courage + Khazaka, Cologne, Germany), a planar glass electrode. The pH is a measure of acidity and alkalinity of a solution and it indicates the concentration of the hydrogen ions in an aqueous solution. Reference values of human skin have been reported to range from 4 to 6.

  • Means of duplicate measurements per skin area at right lower leg lateral, right midvolar forearm
  • If measurements are not possible at right leg/arm (e.g. due to amputation) they will be conducted at contralateral skin areas
Week 0, Week 12 ± 1, Week 24 ± 1
Skin surface temperature [°C] on right lower leg lateral, right midvolar forearm
Time Frame: Week 0, Week 12 ± 1, Week 24 ± 1

Skin surface temperature was measured with the Skin-Thermometer ST 500 (Courage+Khazaka electronic GmbH).

  • Means of duplicate measurements per skin area in °C at right lower leg lateral, right midvolar forearm
  • If measurements are not possible at right leg/arm (e.g. due to amputation) they will be conducted at contralateral skin areas
Week 0, Week 12 ± 1, Week 24 ± 1
Quality of Life (QoL) (residents without cognitive impairment): WHO-Five Well-being Index (WHO = World Health Organization)
Time Frame: Week 0, Week 24 ± 1

Self-completion of the WHO-Five Well-being Index by residents without cognitive impairment. The German version of the WHO-Five Well-being Index questionnaire published by the World Health Organization in 1998 will be used. Scores range from '5' (all the time) to '0' (never) for in total five items.The sum scores range from 0, indicating the lowest well-being, to 25, indicating the highest well-being. A cut-off score of < 13 is recommended. Means will be calculated.

◦ Means
Week 0, 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)
Time Frame: Week 0, Week 24 ± 1
The QUALIDEM assessment is a dementia-specific quality of life (QoL) instrument carried out by the nursing staff that allows a proxy-based QoL rating in all stages of dementia.The German version of the QUALIDEM version 2.0 published in 2015 will be used.Residents with a very severe dementia will answer the 18-item Instrument.To assess whether the resident is affected by mild to severe dementia or very severe dementia the global deterioration scale (GDS) will be used (see Outcome 22).
Week 0, Week 24 ± 1
Quality of Life (QoL) (cognitively impaired residents): QUALIDEM 37-Item Assessment
Time Frame: Week 0, Week 24 ± 1
The QUALIDEM assessment is a dementia-specific quality of life (QoL) instrument carried out by the nursing staff that allows a proxy-based QoL rating in all stages of dementia.The German version of the QUALIDEM version 2.0 published in 2015 will be used.In case the resident is affected by a mild to severe dementia the 37-item assessment will be used.To assess whether the resident is affected by mild to severe dementia or very severe dementia the global deterioration scale (GDS) will be used (see Outcome 22).
Week 0, Week 24 ± 1
Itch Assessment
Time Frame: Week 0, Week 12 ± 1, Week 24 ± 1
  • Self-completion of the 5-D itch scale by residents without cognitive impairment (according to GDS score of 1)
  • The score of the 5-D Itch scale ranges from '5' (no pruritus) to '25' (most severe pruritus) and contains five items measuring pruritus over the past two weeks.
  • Means
Week 0, Week 12 ± 1, Week 24 ± 1
Pain Assessment (residents without cognitive impairment): numeric rating scale
Time Frame: Week 0, Week 12 ± 1, Week 24 ± 1
◦ Self-completion of a numeric rating scale (NRS with total scores from 0: minimum pain to 10: maximum pain) to measure pain by residents without cognitive impairment. Means of the total score will be calculated.
Week 0, Week 12 ± 1, Week 24 ± 1
Pain Assessment (cognitively impaired residents): Verbal rating scale
Time Frame: Week 0, Week 12 ± 1, Week 24 ± 1
◦ Verbal rating scale (proxy rated) to measure pain in cognitively impaired residents (VRS with total scores from 0: minimum pain to 10: maximum pain). Means of the total score will be calculated.
Week 0, Week 12 ± 1, Week 24 ± 1
Assesment of dementia: Global Deterioration scale.
Time Frame: Week 0
To assess whether the resident is affected by mild to severe dementia or very severe dementia the global deterioration scale (GDS) will be used. GDS scores from 2 to 6 indicate a mild to severe dementia and the 37-item assessment of the QUALIDEM tool will be used (see Outcome 18). A GDS score of 7 indicates very severe dementia and the 18-item QUALIDEM tool will be used (see Outcome 17).
Week 0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

PD Dr. Jan Kottner

Investigators

  • Principal Investigator: Jan Kottner, Prof. Dr., Charite University, Berlin, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2018

Primary Completion (Actual)

June 4, 2021

Study Completion (Actual)

June 4, 2021

Study Registration Dates

First Submitted

January 21, 2019

First Submitted That Met QC Criteria

January 30, 2019

First Posted (Actual)

January 31, 2019

Study Record Updates

Last Update Posted (Actual)

August 9, 2021

Last Update Submitted That Met QC Criteria

August 6, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRC-SP-A-30

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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