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 | 2023/08/24 20:32:23 |
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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
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
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
No longer recruiting
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
| 2023 | 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
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
