Skin Health and Effectiveness of Standardized Skin Care Regimens in Nursing Home Residents

Study Overview
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Brief Summary
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Residents of institutional long-term care facilities are at high risk for developing skin and tissue diseases, e.g. xerosis cutis (including pruritus), infections (e.g., tinea pedis, candidiasis), chronic wounds or neoplastic changes (e.g. actinic keratosis, malignant melanoma) but there are few epidemiological figures about the actual frequencies of these conditions in nursing homes. Therefore, in the first part of this study we aim at measuring key dermatological conditions and associated health and functional status, and the skin care practice of aged nursing home residents (prevalence study). Basic skin care interventions are believed to reduce skin dryness and to enhance skin health. Thus, the second aim of this study is to investigate the effectiveness of two structured skin care regimens compared to the routine standard skin care on skin health in nursing home residents (intervention study). The study will be conducted in a random sample of seven out of approximately 300 institutional long term care facilities of the federal state of Berlin.

Official Title
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A Prevalence and Multi-center Randomized Parallel-group Pragmatic Trial to Compare the Effectiveness of Standardized Skin Care Regimens on Skin Health in Nursing Home Residents

Conditions
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Xerosis Cutis

Intervention / Treatment
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* Other: Cetaphil® Restoraderm
* Other: Excipial


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Prevalence study Living in the nursing home at the time of data collection; Being 65+ years; Written informed consent (or by legal representative); Additional inclusion criteria for the intervention study Overall dry skin score (ODS) of 2 to 4 at the right and left leg; Willingness and ability to fulfil the study requirements. Exclusion Criteria: Prevalence study Residents at the end of life (dying persons). Additional exclusion criteria for the intervention study Any dermatological condition or skin affection, e.g. acute weeping, excoriated or inflammatory dermatitis, or skin treatment which may interfere with the study assessments at the discretion of the investigator; Any unstable acute or chronic pathology or condition that may interfere with the study conduct at the discretion of the investigator; Any use of topical drugs on the investigational areas two weeks prior to inclusion; Systemic application of corticosteroids, antihistamine or other anti-inflammatory drugs; Known allergy or intolerance to any ingredient of the study products, e.g. urea.

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cetaphil® Restoraderm<br>Cetaphil® Restoraderm Body Wash, once daily for 8 weeks and Cetaphil® Restoraderm Body Moisturizer, twice daily for 8 weeks | Other: Cetaphil® Restoraderm<br> <br> |
| Experimental: Excipial<br>Excipial Kids Body Wash, once daily for 8 weeks and Excipial U Lipolotio (4% urea), twice daily for 8 weeks | Other: Excipial<br> <br> |
| No Intervention: Standard skin care<br>Usual skin care routine of the nursing home resident | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Overall Dry Skin Score (ODS) | Clinical assessment of the presence or severity of skin dryness using a five point rating scale at right lower leg. The Overall Dry Skin score 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. | Baseline; Day 56+/-4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stratum Corneum Hydration (SCH) | Change in Stratum corneum hydration (SCH) at the lower leg. Instrumental skin measurements were conducted to characterize possible effects of the interventions in terms of skin function. The stratum corneum hydration 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.Values > 40 a.u. are often considered 'normal', whereas values < 40 a.u. are regarded as typical for dry Skin. | Baseline, Day 56 +/- 4 | 
| Transepidermal Water Loss (TEWL) | Change in Transepidermal water loss (TEWL) at the lower leg. Transepidermal water loss 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. | Baseline, Day 56 +/- 4 | 
| Skin Surface pH | Changes in Skin surface pH at the lower leg. 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. | Baseline, Day 56 +/- 4 | 
| Itch Assessment. Question 1. Hours of Itching (1 = Less Than 6 Hours/Day; 2 = 6-12 Hours/Day; 3 = 12-18 Hours/Day; 4 = 18-23hours/Day; 5 = All Day) at Baseline | Self-completion of the 5-D itch scale. Having a 6-CIT score of 7 or lower was the criterion to administer the 5-D itch scale.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. A possible cognitive impairment was tested using the Six Item Cognitive Impairment Test on Day 0. It includes six simple questions, for example 'What year is it?' or 'Count backwards from 20 to 10. Scores may range from 0 (= no sign of cognitive impairment) to a maximum score of 28 (= significant cognitive impairment). Residents with sum scores > 8 were classified as 'cognitively impaired'. | Baseline | 
| Number of Participants With a Pressure Ulcer at Baseline | Clinical assessment of the presence of a pressure ulcer. | Baseline | 
| Number of Participants With Incontinence Associated Dermatitis (IAD) at Baseline | Clinical assessment of the presence of incontinence associated dermatitis according to the IAD-IT classification | Baseline | 
| Quality of Sleep. Question 1. Light Sleep (0) - Deep Sleep (10) at Baseline | Self-completion of the Richards-Campbell Sleep Questionnaire (RCSQ).Sleep quality was assessed with the Pittsburgh Richard Campbell Sleep Quality Assessment. Five questions were asked regarding the sleep quality for the last night via 0-100mm visual analogue scales. The interrater reliability and the most usefulness was recently supported. | Baseline | 
| Quality of Life Sum Score at Baseline | Self-completion of the WHO-Five Well-being Index. Well-being was assessed with the WHO-Five Well-being Index. The German version of the questionnaire published by the World Health Organization in 1998 was used. Scores range from '5' (all the time) to '0' (never) for in total five items. Simple questions were asked regarding well-being in the last two weeks, e.g. 'In the last two weeks … I was happy' or '…I was relaxed'. 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. The validity and reliability of the questionnaire was recently supported. | Baseline | 
| Number of Participants With Pressure Ulcer at Day 28 +/-3 | Clinical assessment of the presence of pressure ulcer. | Day 28 +/-3 | 
| Number of Participants With Pressure Ulcer at Day 56 +/-3 | Clinical assessment of the presence of a pressure ulcer. | Day 56 +/-3 | 
| Number of Participants With Skin Tears at Baseline | Clinical assessment of the presence of skin tears according to the STAR Classification | Baseline | 
| Number of Participants With Skin Tears at Day 28 +/-3 | Clinical assessment aof the presence of skin tears according to the STAR Classification | Day 28 +/-3 | 
| Number of Participants With Skin Tears at Day 56 +/-3 | Clinical assessment aof the presence of skin tears according to the STAR Classification | Day 56 +/-3 | 
| Number of Participants With Incontinence Associated Dermatitis (IAD) at Day 28 +/-3 | Clinical assessment of the presence and/or severity of incontinence associated dermatitis according to the IAD-IT classification | Day 28 +/-3 | 
| Number of Participants With Incontinence Associated Dermatitis (IAD) at Day 56 +/-3 | Clinical assessment of the presence and/or severity of incontinence associated dermatitis according to the IAD-IT classification | Day 56 +/-3 | 
| Quality of Life Sum Score at Day 56 +/-3 | Self-completion of the WHO-Five Well-being Index. Well-being was assessed with the WHO-Five Well-being Index. The German version of the questionnaire published by the World Health Organization in 1998 was used. Scores range from '5' (all the time) to '0' (never) for in total five items. Simple questions were asked regarding well-being in the last two weeks, e.g. 'In the last two weeks … I was happy' or '…I was relaxed'. 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. The validity and reliability of the questionnaire was recently supported. | Day 56 +/-3 | 
| Quality of Sleep. Question 2. Never Fall Asleep (0) - Immediately Fall Asleep (10) at Baseline | Self-completion of the Richards-Campbell Sleep Questionnaire (RCSQ).Sleep quality was assessed with the Pittsburgh Richard Campbell Sleep Quality Assessment. Five questions were asked regarding the sleep quality for the last night via 0-100mm visual analogue scales. The interrater reliability and the most usefulness was recently supported. | Baseline | 
| Quality of Sleep. Question 3. Awake All Night (0) - Awake Very Little (10) at Baseline | Self-completion of the Richards-Campbell Sleep Questionnaire (RCSQ).Sleep quality was assessed with the Pittsburgh Richard Campbell Sleep Quality Assessment. Five questions were asked regarding the sleep quality for the last night via 0-100mm visual analogue scales. The interrater reliability and the most usefulness was recently supported. | Baseline | 
| Quality of Sleep. Question 4. Not Back to Sleep (0) - Back to Sleep Immediately (10) at Baseline | Self-completion of the Richards-Campbell Sleep Questionnaire (RCSQ).Sleep quality was assessed with the Pittsburgh Richard Campbell Sleep Quality Assessment. Five questions were asked regarding the sleep quality for the last night via 0-100mm visual analogue scales. The interrater reliability and the most usefulness was recently supported. | Baseline | 
| Quality of Sleep. Question 5. Bad Sleep (0) - Good Sleep (10) at Baseline | Self-completion of the Richards-Campbell Sleep Questionnaire (RCSQ).Sleep quality was assessed with the Pittsburgh Richard Campbell Sleep Quality Assessment. Five questions were asked regarding the sleep quality for the last night via 0-100mm visual analogue scales. The interrater reliability and the most usefulness was recently supported. | Baseline | 
| Quality of Sleep. Question 1. Light Sleep (0) - Deep Sleep (10) at Day 56 +/-3 | Self-completion of the Richards-Campbell Sleep Questionnaire (RCSQ).Sleep quality was assessed with the Pittsburgh Richard Campbell Sleep Quality Assessment. Five questions were asked regarding the sleep quality for the last night via 0-100mm visual analogue scales. The interrater reliability and the most usefulness was recently supported. | Day 56 +/-3 | 
| Quality of Sleep. Question 2. Never Fall Asleep (0) - Immediately Fall Asleep (10) at Day 56 +/-3 | Self-completion of the Richards-Campbell Sleep Questionnaire (RCSQ).Sleep quality was assessed with the Pittsburgh Richard Campbell Sleep Quality Assessment. Five questions were asked regarding the sleep quality for the last night via 0-100mm visual analogue scales. The interrater reliability and the most usefulness was recently supported. | Day 56 +/-3 | 
| Quality of Sleep. Question 3. Awake All Night (0) - Awake Very Little (10) at Day 56 +/-3 | Self-completion of the Richards-Campbell Sleep Questionnaire (RCSQ).Sleep quality was assessed with the Pittsburgh Richard Campbell Sleep Quality Assessment. Five questions were asked regarding the sleep quality for the last night via 0-100mm visual analogue scales. The interrater reliability and the most usefulness was recently supported. | Day 56 +/-3 | 
| Quality of Sleep. Question 4. Not Back to Sleep (0) - Back to Sleep Immediately (10) at Day 56 +/-3 | Self-completion of the Richards-Campbell Sleep Questionnaire (RCSQ).Sleep quality was assessed with the Pittsburgh Richard Campbell Sleep Quality Assessment. Five questions were asked regarding the sleep quality for the last night via 0-100mm visual analogue scales. The interrater reliability and the most usefulness was recently supported. | Day 56 +/-3 | 
| Quality of Sleep. Question 5. Bad Sleep (0) - Good Sleep (10) at Day 56 +/-3 | Self-completion of the Richards-Campbell Sleep Questionnaire (RCSQ).Sleep quality was assessed with the Pittsburgh Richard Campbell Sleep Quality Assessment. Five questions were asked regarding the sleep quality for the last night via 0-100mm visual analogue scales. The interrater reliability and the most usefulness was recently supported. | Day 56 +/-3 | 
| Itch Assessment. Question 2. Itch Intensity (1 = Not Present; 2 = Mild; 3 = Moderate; 4 = Severe; 5 = Unbearable) at Baseline | Self-completion of the 5-D itch scale. Having a 6-CIT score of 7 or lower was the criterion to administer the 5-D itch scale.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. A possible cognitive impairment was tested using the Six Item Cognitive Impairment Test on Day 0. It includes six simple questions, for example 'What year is it?' or 'Count backwards from 20 to 10. Scores may range from 0 (= no sign of cognitive impairment) to a maximum score of 28 (= significant cognitive impairment). Residents with sum scores > 8 were classified as 'cognitively impaired'. | Baseline | 
| Itch Assessment. Question 3. Changes in Intensity of Itch (Past Two Weeks). (1 = Completely Resolved; 2 = Much Better But Still Present; 3 = Little Bit Better, But Still Present; 4 = Unchanged, 5 = Getting Worse) at Baseline | Self-completion of the 5-D itch scale. Having a 6-CIT score of 7 or lower was the criterion to administer the 5-D itch scale.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. A possible cognitive impairment was tested using the Six Item Cognitive Impairment Test on Day 0. It includes six simple questions, for example 'What year is it?' or 'Count backwards from 20 to 10. Scores may range from 0 (= no sign of cognitive impairment) to a maximum score of 28 (= significant cognitive impairment). Residents with sum scores > 8 were classified as 'cognitively impaired'. | Baseline | 
| Itch Assessment. Question 4. Affecting of Sleep (See Score Informations in the Outcome Measure Description) at Baseline | Self-completion of the 5-D itch scale. Question 4: 1=Never affects sleep;2=Occasionally delays falling asleep;3=Frequently delays falling asleep;4=Delays falling asleep and occasionally wakes me up;5=Delays falling asleep and frequently wakes me up at night. Having a 6-CIT score of 7 or lower was the criterion to administer the 5-D itch scale.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. A possible cognitive impairment was tested using the Six Item Cognitive Impairment Test on Day 0. It includes six simple questions, for example 'What year is it?' or 'Count backwards from 20 to 10. Scores may range from 0 (= no sign of cognitive impairment) to a maximum score of 28 (= significant cognitive impairment). Residents with sum scores > 8 were classified as 'cognitively impaired'. | Baseline | 
| Itch Assessment. Question 5. Affecting of Daily Activities ( 1 = Never Affects Activity; 2 = Rarely Affects Activity; 3 = Occasionally Affects Activity; 4 = Frequently Affects Activity; 5 = Always Affects Activity) at Baseline | Self-completion of the 5-D itch scale. Having a 6-CIT score of 7 or lower was the criterion to administer the 5-D itch scale.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. A possible cognitive impairment was tested using the Six Item Cognitive Impairment Test on Day 0. It includes six simple questions, for example 'What year is it?' or 'Count backwards from 20 to 10. Scores may range from 0 (= no sign of cognitive impairment) to a maximum score of 28 (= significant cognitive impairment). Residents with sum scores > 8 were classified as 'cognitively impaired'. | Baseline | 
| Itch Assessment. Question 1. Hours of Itching (1 = Less Than 6hours/Day; 2 = 6-12 Hours/Day; 3 = 12-18 Hours/Day; 4 = 18-23hours/Day; 5 = All Day) at Day 56 +/-3 | Self-completion of the 5-D itch scale. Having a 6-CIT score of 7 or lower was the criterion to administer the 5-D itch scale.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. A possible cognitive impairment was tested using the Six Item Cognitive Impairment Test on Day 0. It includes six simple questions, for example 'What year is it?' or 'Count backwards from 20 to 10. Scores may range from 0 (= no sign of cognitive impairment) to a maximum score of 28 (= significant cognitive impairment). Residents with sum scores > 8 were classified as 'cognitively impaired'. | Day 56 +/-3 | 
| Itch Assessment. Question 2. Itch Intensity (1 = Not Present; 2 = Mild; 3 = Moderate; 4 = Severe; 5 = Unbearable) at Day 56 +/-3 | Self-completion of the 5-D itch scale. Having a 6-CIT score of 7 or lower was the criterion to administer the 5-D itch scale.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. A possible cognitive impairment was tested using the Six Item Cognitive Impairment Test on Day 0. It includes six simple questions, for example 'What year is it?' or 'Count backwards from 20 to 10. Scores may range from 0 (= no sign of cognitive impairment) to a maximum score of 28 (= significant cognitive impairment). Residents with sum scores > 8 were classified as 'cognitively impaired'. | Day 56 +/-3 | 
| Itch Assessment. Question 3. Changes in Intensity of Itch (Past Two Weeks). (1 = Completely Resolved; 2 = Much Better But Still Present; 3 = Little Bit Better, But Still Present; 4 = Unchanged, 5 = Getting Worse) at Day 56 +/-3 | Self-completion of the 5-D itch scale. Having a 6-CIT score of 7 or lower was the criterion to administer the 5-D itch scale.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. A possible cognitive impairment was tested using the Six Item Cognitive Impairment Test on Day 0. It includes six simple questions, for example 'What year is it?' or 'Count backwards from 20 to 10. Scores may range from 0 (= no sign of cognitive impairment) to a maximum score of 28 (= significant cognitive impairment). Residents with sum scores > 8 were classified as 'cognitively impaired'. | Day 56 +/-3 | 
| Itch Assessment. Question 4. Affecting of Sleep (See Score Details in the Outcome Measure Description) at Day 56 +/-3 | Self-completion of the 5-D itch scale. Question 4: 1=Never affects sleep;2=Occasionally delays falling asleep;3=Frequently delays falling asleep;4=Delays falling asleep and occasionally wakes me up;5=Delays falling asleep and frequently wakes me up at night. Having a 6-CIT score of 7 or lower was the criterion to administer the 5-D itch scale.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. A possible cognitive impairment was tested using the Six Item Cognitive Impairment Test on Day 0. It includes six simple questions, for example 'What year is it?' or 'Count backwards from 20 to 10. Scores may range from 0 (= no sign of cognitive impairment) to a maximum score of 28 (= significant cognitive impairment). Residents with sum scores > 8 were classified as 'cognitively impaired'. | Day 56 +/-3 | 
| Itch Assessment. Question 5. Affecting of Daily Activities ( 1 = Never Affects Activity; 2 = Rarely Affects Activity; 3 = Occasionally Affects Activity; 4 = Frequently Affects Activity; 5 = Always Affects Activity) at Day 56 +/-3 | Self-completion of the 5-D itch scale. Having a 6-CIT score of 7 or lower was the criterion to administer the 5-D itch scale.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. A possible cognitive impairment was tested using the Six Item Cognitive Impairment Test on Day 0. It includes six simple questions, for example 'What year is it?' or 'Count backwards from 20 to 10. Scores may range from 0 (= no sign of cognitive impairment) to a maximum score of 28 (= significant cognitive impairment). Residents with sum scores > 8 were classified as 'cognitively impaired'. | Day 56 +/-3 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Skin health, Nursing, Long-term care