UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052133 |
|---|---|
| Receipt number | R000059503 |
| Scientific Title | Effects of intervention using the Internet-based rehabilitation information sharing system on psychological stress of family caregivers of inpatients |
| Date of disclosure of the study information | 2023/09/07 |
| Last modified on | 2023/09/07 00:40:31 |
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Basic information
Public title
Effects of intervention using the Internet-based rehabilitation information sharing system on psychological stress of family caregivers of inpatients
Acronym
Effects of intervention using the Internet-based rehabilitation information sharing system on psychological stress of family caregivers of inpatients
Scientific Title
Effects of intervention using the Internet-based rehabilitation information sharing system on psychological stress of family caregivers of inpatients
Scientific Title:Acronym
Effects of intervention using the Internet-based rehabilitation information sharing system on psychological stress of family caregivers of inpatients
Region
| Japan |
Condition
Condition
Patients admitted to a rehabilitation hospital and their families
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of intervention using the Internet-based rehabilitation information sharing (IRIS) system on family caregivers' anxiety and depression
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Anxiety and depression of family caregivers (at admission, discharge, and one month after discharge)
Key secondary outcomes
Health related Quality of life of family caregivers (at admission, discharge, and one month after discharge)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Weekly reports with photos and videos showing rehabilitation progress and activities of daily living (ADLs) of the patients are provided for family caregivers via the internet
Interventions/Control_2
Information on the progress of rehabilitation and ADLs of the patients is provided to the families via conventional care processes (e.g. direct involvement in conferences)
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The participants are patients admitted to a rehabilitation hospital and their families
Key exclusion criteria
1.Patients who were institutionalized prior to admission
2.Institutionalized patients
3.Transferred to other hospitals
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Yumi |
| Middle name | |
| Last name | Higuchi |
Organization
Osaka Metropolitan University
Division name
Graduate School of Rehabilitation Science
Zip code
583-8555
Address
3-7-30 Habikino, Habikino City, Osaka 583-8555, Japan
TEL
072-950-2111
Higu_reha@omu.ac.jp
Public contact
Name of contact person
| 1st name | Wataru |
| Middle name | |
| Last name | Kozuki |
Organization
Osaka Metropolitan University
Division name
Graduate School of Rehabilitation Science
Zip code
583-8555
Address
3-7-30 Habikino, Habikino City, Osaka 583-8555, Japan
TEL
072-950-2111
Homepage URL
wataru.k.69@gmail.com
Sponsor or person
Institute
Graduate School of Rehabilitation Science, Osaka Metropolitan University
Institute
Department
Personal name
Funding Source
Organization
Graduate School of Rehabilitation Science, Osaka Metropolitan University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Department of Rehabilitation, Tezukayama Rehabilitation Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee, Graduate School of Comprehensive Rehabilitation, Osaka Prefecture University
Address
3-7-30 Habikino, Habikino City, Osaka 583-8555, Japan
Tel
072-950-2111
mc701009@st.osakafu-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 | 09 | Month | 07 | 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
176
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
Completed
Date of protocol fixation
| 2021 | Year | 07 | Month | 16 | Day |
Date of IRB
| 2020 | Year | 12 | Month | 16 | Day |
Anticipated trial start date
| 2021 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 04 | Month | 27 | Day |
Date of closure to data entry
| 2023 | Year | 04 | Month | 28 | Day |
Date trial data considered complete
| 2023 | Year | 04 | Month | 28 | Day |
Date analysis concluded
| 2023 | Year | 05 | Month | 15 | Day |
Other
Other related information
Management information
Registered date
| 2023 | Year | 09 | Month | 07 | Day |
Last modified on
| 2023 | Year | 09 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059503
