UMIN-CTR Clinical Trial

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
Email	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
Email	nakamura@jrchcn.ac.jp

Sponsor
Institute	Japanese Red Cross Academy
Institute
Department

Funding Source
Organization	Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

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
Email	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
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Preinitiation
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	2022 Year 09 Month 30 Day
Date of closure to data entry
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	2021 Year 02 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049525

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

Contact us.