UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043375 |
|---|---|
| Receipt number | R000049525 |
| Scientific Title | The Effects of Education Program for Improve Dry Skin conditions, in Community-dwelling Elderly: A Randomized Controlled Trial |
| Date of disclosure of the study information | 2021/02/20 |
| Last modified on | 2026/08/24 10:10:26 |
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Basic information
Public title
The Effects of an Education Program to Improve Dry Skin conditions, in Community-dwelling Elderly: A Randomized Controlled Trial
Acronym
The Effects of Education Program for Improving Dry Skin in Community-dwelling Elderly
Scientific Title
The Effects of Education Program for Improve Dry Skin conditions, in Community-dwelling Elderly: A Randomized Controlled Trial
Scientific Title:Acronym
The Effects of Education Program for Improving Dry Skin in Community-dwelling Elderly
Region
| Japan |
Condition
Condition
Dry skin
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine the effects of an educational program aimed at improving the conditions community-dwelling elderly people with dry skin.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The change of water content of the stratum corneum in the anterior surface of the lower leg over a 6 month period from the beginning of intervention.
Key secondary outcomes
The change of water content of the stratum corneum in the anterior surface of the lower leg over a 4month period from the beginning of intervention.
The change of water content of the stratum corneum in the surface of the forearm.
Symptoms of dry skin (scale, rhagades, feeling of dryness, pruritus).
Actions related to skin care (frequency of moisturizer use, frequency of bathing agent use, how take moisturizer is used, actions when bathing, environmental adjustment).
Frequency of skin observations.
Amount of moisturizer used (in 4months and 6months from the beginning of intervention).
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Continuous support for 4 months and follow-up for 2 months by a nurse
6 face-to-face sessions over a period of 4 months
To give a textbook and a self-management handbook
To provide moisturizer
Interventions/Control_2
To provide a concise explanatory literature
To provide moisturizer
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Community-dwelling elderly aged 65 or over.
2)with dry skin.
3) Those who have not been certified as long-term care, or those who have been classified as Support Required 1 or 2.
4) Those with enough cognitive and communicative ability to be trained in skincare and practice it.
5) Those who have the ability to apply moisturizer by themselves.
6) Those in preparation for the transtheoretical model of behavior change.
Key exclusion criteria
1)Those who have intense pruritic scratches and bleeding on the skin.
2)Those with skin health impairment; ulcer, wound, lymphedema.
3)Those who are using prescribed moisturizers, etc.
4)Those who have used short-term stay for care for 12 days or more per month on average for the past 3 months.
5)Those who respond to Patch testing.
Target sample size
64
Research contact person
Name of lead principal investigator
| 1st name | Motoe |
| Middle name | |
| Last name | Nakamura |
Organization
Japanese Red Cross Hiroshima College of Nursing
Division name
Gerontological Nursing
Zip code
738-0052
Address
1-2 Ajinadai-Higashi Hatsukaichi-shi Hiroshima
TEL
0829-20-2800
nakamura@jrchcn.ac.jp
Public contact
Name of contact person
| 1st name | Motoe |
| Middle name | |
| Last name | Nakamura |
Organization
Japanese Red Cross Hiroshima College of Nursing
Division name
Gerontological Nursing
Zip code
738-0052
Address
1-2 Ajinadai-Higashi Hatsukaichi-shi Hiroshima
TEL
0829-20-2800
Homepage URL
nakamura@jrchcn.ac.jp
Sponsor or person
Institute
Japanese Red Cross Academy
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee, Japanese Red Cross Hiroshima College of Nursing
Address
1-2 Ajinadai-Higashi Hatsukaichi-shi Hiroshima
Tel
0829-20-2800
rinri@jrchcn.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 02 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
64
Results
In 64 participants (intervention: 32, control: 32), the intervention group showed a significantly greater increase in lower leg stratum corneum hydration at 6 months, the primary outcome (p = .012; d = 0.64). Secondary outcomes also favored the intervention group: greater hydration change at 4 months, higher moisturizer use frequency at 4 months, better application method at 6 months, more frequent skin observation at 4 and 6 months, and greater moisturizer usage at both 4 and 6 months.
Results date posted
| 2025 | Year | 09 | Month | 02 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
currently under submission
Date of the first journal publication of results
Baseline Characteristics
Selection criteria for study participants were:
(1) Having dry skin (stratum corneum moisture content on the anterior lower leg measured with a portable moisture meter: Mobile Moisture HP10-NTM <= 25),
(2) Aged 65 years or older,
(3) Independent or requiring Support Level 1 or 2,
(4) Possessing the comprehension and communication skills necessary to receive and implement skin care education,
(5) Capable of applying moisturizer,
(6) Being in the preparatory stage of the Change Stage Model.
Participants with health conditions such as ulcers under treatment or lymphedema, those experiencing severe pruritus, and those using prescription medications were excluded.
Participant flow
Subject referrals were obtained from regional comprehensive support centers, service-provided senior housing, or care houses (low-cost nursing homes). Furthermore, due to the spread of the novel coronavirus disease (COVID-19), access to service providers and senior housing facilities became difficult, making it impossible to obtain referrals. Consequently, referrals were expanded to include social welfare councils, which provided referrals to senior activity centers and other venues for elderly activities.
Adverse events
Two subjects (intervention group) reported that the moisturizer was unsuitable for them (causing itching and redness). Use was discontinued immediately. These were temporary symptoms, and no subsequent symptoms occurred after discontinuation.
Outcome measures
Data analysis involved confirming homogeneity between the intervention and control groups through baseline comparisons. Subsequently, between-group comparisons were conducted at evaluation points (4 months and 6 months after intervention initiation). Tests used included unpaired t-tests, Mann-Whitney U tests, and Fisher's exact probability tests, selected based on the characteristics of each data item. SPSS Statistics (Ver. 24) was used for analysis, with a significance level set at 5%. Effect sizes were calculated as d for the independent t-test and r for the Mann-Whitney U test. Missing data at assessment points due to dropouts were imputed using the LOCF (last observation carried forward) method, substituting the last observed value, and an Intention to Treat (ITT) analysis was performed.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 01 | Month | 14 | Day |
Date of IRB
| 2021 | Year | 01 | Month | 14 | Day |
Anticipated trial start date
| 2021 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
| 2024 | Year | 05 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 02 | Month | 19 | Day |
Last modified on
| 2026 | Year | 08 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049525
