UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051132 |
|---|---|
| Receipt number | R000058314 |
| Scientific Title | Examination of the Effects of Feedback on Sleep Reports and Regular Health Guidance Utilizing ICT for Community-Dwelling Elderly Individuals Living Alone and Frail, and User-Friendliness A Cluster Randomized Controlled Trial |
| Date of disclosure of the study information | 2023/05/25 |
| Last modified on | 2023/05/23 08:33:41 |
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Basic information
Public title
Examination of the Effects of Feedback on Sleep Reports and Regular Health Guidance Utilizing Sleep Measurement Devices for Community-Dwelling Elderly Individuals Living Alone and Frail, and User-Friendliness
Acronym
Effectiveness of Health Guidance Using Sleep Measurement Devices
Scientific Title
Examination of the Effects of Feedback on Sleep Reports and Regular Health Guidance Utilizing ICT for Community-Dwelling Elderly Individuals Living Alone and Frail, and User-Friendliness
A Cluster Randomized Controlled Trial
Scientific Title:Acronym
Effectiveness of Health Guidance Using ICT Devices
Region
| Japan |
Condition
Condition
Healthy older adults
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examining the Effects of Interventions Utilizing Feedback from Sleep Reports Generated Using Devices Capable of Continuously Monitoring the Sleep of Community-Dwelling Older Adults, along with Regular Health Guidance, and Assessing Their User-Friendliness
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Athens Insomnia Scale
Key secondary outcomes
Level of interest in sleep, self-awareness of one's sleep condition, awareness of sleep habits, exercise habits, dietary habits, social engagement status, caregiving level (for long-term care insurance users only), presence of frailty, feelings of loneliness and isolation, cognitive function level, presence of sleep disorders.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Cluster
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
3
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Monthly delivery of sleep reports through sleep monitoring devices and conducting nurse telephone interventions based on the reports (for a duration of 3 months
Interventions/Control_2
Sleep measurement using sleep monitoring devices and only sending sleep reports (for a duration of 3 months)
Interventions/Control_3
No intervention
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 individuals living alone aged 65 and above including those who live alone during the day
elderly households
individuals classified as requiring support level 1 and 2 under the long-term care insurance system
2
Family members referred by those mentioned in 1
Key exclusion criteria
Already diagnosed with sleep-related disorders.
Currently hospitalized.
Residing in a long-term care facility.
Already using a similar sleep monitoring device.
Unable to be followed up for a duration of 6 months due to specific reasons.
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | Miyae |
| Middle name | |
| Last name | Yamakawa |
Organization
Osaka University
Division name
Health Science
Zip code
5650871
Address
1-7 Yamadaoka, Suita City
TEL
0668792543
miyatabu@sahs.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Miyae |
| Middle name | |
| Last name | Yamakawa |
Organization
Osaka University
Division name
Health Science
Zip code
5650871
Address
1-7 Yamadaoka, Suita City
TEL
0668792543
Homepage URL
http://sahswww.med.osaka-u.ac.jp/~agns1/epi/research2.html
miyatabu@sahs.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University
Institute
Department
Personal name
Funding Source
Organization
AMED
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
Ethics Review Committee for Interventional Research at Osaka University Medical School Hospital
Address
2-2 Yamadaoka, Suita City
Tel
0668792543
rinri@hp-crc.med.osaka-u.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
| 2023 | Year | 05 | Month | 25 | 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
| 2023 | Year | 05 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 05 | Month | 23 | Day |
Last modified on
| 2023 | Year | 05 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058314
