UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046382 |
|---|---|
| Receipt number | R000052743 |
| Scientific Title | Effects of ICT-based sleep report feedback and regular health guidance on the older living alone or pre-frail or frail people in the community: a randomized controlled trial |
| Date of disclosure of the study information | 2021/12/15 |
| Last modified on | 2021/12/15 11:11:05 |
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Basic information
Public title
A study of the effects of regular health guidance and feedback of sleep reports to older people living in the community using a sleep measurement device
Acronym
Sakai Sleep ICT Study
Scientific Title
Effects of ICT-based sleep report feedback and regular health guidance on the older living alone or pre-frail or frail people in the community: a randomized controlled trial
Scientific Title:Acronym
RCT of ICT-based sleep report feedback and health guidance for community-dwelling older people
Region
| Japan |
Condition
Condition
normal older people
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effectiveness of an intervention using feedback from sleep reports and regular health guidance generated using a device that continuously measures the sleep of community-dwelling older people.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Athens insomnia scale
Key secondary outcomes
Interest in sleep: whether or not you are interested in sleep and how satisfied you are with your sleep (1-10)
Degree of understanding of own sleep situation: 16 items about bedtime, waking time, dreaming, sleep talk, behavior during sleep, etc.
Awareness of sleep habits: do you want to improve/maintain your sleep habits (very much, fairly much, not very much, not at all)
Presence of sleep disturbances
Change in exercise habits
Change in eating habits
Participation in social activities
Subjective sense of health: 4 levels
Basic checklist for daily life
Loneliness: Japanese version of the UCLA Loneliness Scale (3rd edition)
Social isolation (Lubben Social Network Scale 6-item short version: LNSN-6)
Depression (Geriatric Depression Scale: GDS)
Feelings of security with the sensor: anxiety and security with the sensor itself (quite secure, a little secure, not feeling particularly secure, a little secure, quite secure), and if anxious
Expectations for the sensor: to be able to monitor sleep/ to be able to notice any changes quickly/ to monitor daily life/ don't know/ other
Translated with www.DeepL.com/Translator (free version)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Intervention
No. of arms
3
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Intervention group A: Monthly sleep reports are sent by a sleep monitoring device and a professional (public health nurse/nurse) expertly interprets the sleep data and provides telephone intervention to the subject as soon as possible after sending the sleep report (6 months).
Interventions/Control_2
Intervention Group B: For the first 3 months, as in Intervention Group A, a sleep monitoring device will be used to send monthly sleep reports, and a professional (public health nurse/nurse) will interpret the sleep data professionally and provide telephone intervention to the subject as soon as possible after sending the sleep reports. In the following 3 months, the sleep monitoring device will only measure sleep and send sleep reports (3 months).
Interventions/Control_3
Intervention group C (control group): sleep measurement with sleep monitoring device and sending sleep reports only (6 months)
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
The subjects of this study must meet one of the following criteria at the start of the study
Elderly people (aged 65 and over) living alone in the community
People who "need support" according to long-term care insurance
With the cooperation of the city of Sakai, we will invite applications from the public via the internet and posters
Key exclusion criteria
People who already seek regular specifically medical attention for sleep-related conditions
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Manabu |
| Middle name | |
| Last name | Ikeda |
Organization
Osaka University
Division name
Department of Psychiatry, Graduate School of Medicine
Zip code
5650871
Address
2-2, Yamadaoka, Suita city
TEL
0668793050
mikeda@psy.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Miyae |
| Middle name | |
| Last name | Yamakawa |
Organization
Osaka University
Division name
Department of Geriatric Nursing, Graduate School of Medicine
Zip code
5650871
Address
1-7, Yamadaoka, Suita City
TEL
0668792543
Homepage URL
miyatabu@sahs.med.osaka-u.ac.jp
Sponsor or person
Institute
OsakaUniversity
Institute
Department
Personal name
Funding Source
Organization
NTT-PARAVITA
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka University Hospital Ethics Review Committee
Address
2-2, Yamadaoka, Suita City
Tel
0668795111
rinri-jim@dmi.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
| 2021 | Year | 12 | Month | 15 | 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 | 11 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2021 | Year | 12 | Month | 20 | 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 | 12 | Month | 15 | Day |
Last modified on
| 2021 | Year | 12 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052743
