Clinical trial NCT02216526: Skin Health and Effectiveness of Standardized Skin Care Regimens in Nursing Home Residents
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Xerosis Cutis
Keywords: Skin health
Nursing
Long-term care
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2014-08-15
Enrollment: 133
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change From Baseline in Overall Dry Skin Score (ODS)
timeFrame: Baseline; Day 56+/-4
Secondary outcomes:
measure: Stratum Corneum Hydration (SCH)
timeFrame: Baseline, Day 56 +/- 4
measure: Transepidermal Water Loss (TEWL)
timeFrame: Baseline, Day 56 +/- 4
measure: Skin Surface pH
timeFrame: Baseline, Day 56 +/- 4
measure: 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
timeFrame: Baseline
measure: Number of Participants With a Pressure Ulcer at Baseline
timeFrame: Baseline
measure: Number of Participants With Incontinence Associated Dermatitis (IAD) at Baseline
timeFrame: Baseline
measure: Quality of Sleep. Question 1. Light Sleep (0) - Deep Sleep (10) at Baseline
timeFrame: Baseline
measure: Quality of Life Sum Score at Baseline
timeFrame: Baseline
measure: Number of Participants With Pressure Ulcer at Day 28 +/-3
timeFrame: Day 28 +/-3
measure: Number of Participants With Pressure Ulcer at Day 56 +/-3
timeFrame: Day 56 +/-3
measure: Number of Participants With Skin Tears at Baseline
timeFrame: Baseline
measure: Number of Participants With Skin Tears at Day 28 +/-3
timeFrame: Day 28 +/-3
measure: Number of Participants With Skin Tears at Day 56 +/-3
timeFrame: Day 56 +/-3
measure: Number of Participants With Incontinence Associated Dermatitis (IAD) at Day 28 +/-3
timeFrame: Day 28 +/-3
measure: Number of Participants With Incontinence Associated Dermatitis (IAD) at Day 56 +/-3
timeFrame: Day 56 +/-3
measure: Quality of Life Sum Score at Day 56 +/-3
timeFrame: Day 56 +/-3
measure: Quality of Sleep. Question 2. Never Fall Asleep (0) - Immediately Fall Asleep (10) at Baseline
timeFrame: Baseline
measure: Quality of Sleep. Question 3. Awake All Night (0) - Awake Very Little (10) at Baseline
timeFrame: Baseline
measure: Quality of Sleep. Question 4. Not Back to Sleep (0) - Back to Sleep Immediately (10) at Baseline
timeFrame: Baseline
measure: Quality of Sleep. Question 5. Bad Sleep (0) - Good Sleep (10) at Baseline
timeFrame: Baseline
measure: Quality of Sleep. Question 1. Light Sleep (0) - Deep Sleep (10) at Day 56 +/-3
timeFrame: Day 56 +/-3
measure: Quality of Sleep. Question 2. Never Fall Asleep (0) - Immediately Fall Asleep (10) at Day 56 +/-3
timeFrame: Day 56 +/-3
measure: Quality of Sleep. Question 3. Awake All Night (0) - Awake Very Little (10) at Day 56 +/-3
timeFrame: Day 56 +/-3
measure: Quality of Sleep. Question 4. Not Back to Sleep (0) - Back to Sleep Immediately (10) at Day 56 +/-3
timeFrame: Day 56 +/-3
measure: Quality of Sleep. Question 5. Bad Sleep (0) - Good Sleep (10) at Day 56 +/-3
timeFrame: Day 56 +/-3
measure: Itch Assessment. Question 2. Itch Intensity (1 = Not Present; 2 = Mild; 3 = Moderate; 4 = Severe; 5 = Unbearable) at Baseline
timeFrame: Baseline
measure: 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
timeFrame: Baseline
measure: Itch Assessment. Question 4. Affecting of Sleep (See Score Informations in the Outcome Measure Description) at Baseline
timeFrame: Baseline
measure: 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
timeFrame: Baseline
measure: 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
timeFrame: Day 56 +/-3
measure: Itch Assessment. Question 2. Itch Intensity (1 = Not Present; 2 = Mild; 3 = Moderate; 4 = Severe; 5 = Unbearable) at Day 56 +/-3
timeFrame: Day 56 +/-3
measure: 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
timeFrame: Day 56 +/-3
measure: Itch Assessment. Question 4. Affecting of Sleep (See Score Details in the Outcome Measure Description) at Day 56 +/-3
timeFrame: Day 56 +/-3
measure: 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
timeFrame: Day 56 +/-3
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin Berlin
Study officials:
affiliation: Charite University, Berlin, Germany
name: Ulrike Blume-Peytavi, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gabriel S, Hahnel E, Blume-Peytavi U, Kottner J. Prevalence and associated factors of intertrigo in aged nursing home residents: a multi-center cross-sectional prevalence study. BMC Geriatr. 2019 Apr 15;19(1):105. doi: 10.1186/s12877-019-1100-8.
citation: Hahnel E, Blume-Peytavi U, Trojahn C, Kottner J. Associations between skin barrier characteristics, skin conditions and health of aged nursing home residents: a multi-center prevalence and correlational study. BMC Geriatr. 2017 Nov 13;17(1):263. doi: 10.1186/s12877-017-0655-5.
citation: Hahnel E, Blume-Peytavi U, Trojahn C, Dobos G, Jahnke I, Kanti V, Richter C, Lichterfeld-Kottner A, Garcia Bartels N, Kottner J. Prevalence and associated factors of skin diseases in aged nursing home residents: a multicentre prevalence study. BMJ Open. 2017 Sep 24;7(9):e018283. doi: 10.1136/bmjopen-2017-018283.
citation: Hahnel E, Blume-Peytavi U, Trojahn C, Dobos G, Stroux A, Garcia Bartels N, Jahnke I, Lichterfeld-Kottner A, Neels-Herzmann H, Klasen A, Kottner J. The effectiveness of standardized skin care regimens on skin dryness in nursing home residents: A randomized controlled parallel-group pragmatic trial. Int J Nurs Stud. 2017 May;70:1-10. doi: 10.1016/j.ijnurstu.2017.02.006. Epub 2017 Feb 7.
citation: Kottner J, Hahnel E, Trojahn C, Stroux A, Dobos G, Lichterfeld A, Richter C, Blume-Peytavi U. A multi-center prevalence study and randomized controlled parallel-group pragmatic trial to compare the effectiveness of standardized skin care regimens on skin health in nursing home residents: a study protocol. Int J Nurs Stud. 2015 Feb;52(2):598-604. doi: 10.1016/j.ijnurstu.2014.11.007. Epub 2014 Nov 15.