UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025338 |
|---|---|
| Receipt number | R000028520 |
| Scientific Title | Randomized controlled parallel-group comparative study to evaluate the effectiveness of strengths Intervention for self-esteem among the patients with low vision and visual impairments |
| Date of disclosure of the study information | 2016/12/20 |
| Last modified on | 2022/06/25 11:06:33 |
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Basic information
Public title
Randomized controlled parallel-group comparative study to evaluate the effectiveness of strengths Intervention for self-esteem among the patients with low vision and visual impairments
Acronym
Strengths Intervention
Scientific Title
Randomized controlled parallel-group comparative study to evaluate the effectiveness of strengths Intervention for self-esteem among the patients with low vision and visual impairments
Scientific Title:Acronym
Strengths Intervention
Region
| Japan |
Condition
Condition
Self-esteem
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To test the effectiveness of strengths intervention for raising self-esteem and happiness among the persons with low-vision or visual impairments.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The score of Rosenberg's Self-esteem Scale
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
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
| Behavior,custom |
Interventions/Control_1
Strengths intervention
Interventions/Control_2
Control(Waiting-list)
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
| 20 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) those who are enrolled in the research support institutions and are diagnosed as low-vision or visually impaired patients.
2) those who are able to agree on the written informed consent.
3) those who are able to answer questions verbally.
Key exclusion criteria
1) those who are not able to answer the questions verbally.
2) those who are judged that they are not in a condition where they can participate by the staff of the research support institutions.
Target sample size
22
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Motoko Kawashima |
Organization
Keio University School of Medicine
Division name
Department of ophthalmology
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
03-3359-8302
motoko-k@a3.keio.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shinichiro Matsuguma |
Organization
Keio University Graduate School of Medicine
Division name
Department of ophthalmology
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
080-1530-9781
Homepage URL
matsuguma@keio.jp
Sponsor or person
Institute
Keio University School of Medicine
Department of ophthalmology
Institute
Department
Personal name
Funding Source
Organization
Keio University School of Medicine
Department of ophthalmology
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2016 | Year | 12 | 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
Completed
Date of protocol fixation
| 2016 | Year | 10 | Month | 19 | Day |
Date of IRB
| 2016 | Year | 10 | Month | 19 | Day |
Anticipated trial start date
| 2016 | Year | 11 | Month | 17 | Day |
Last follow-up date
| 2018 | Year | 11 | Month | 17 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 12 | Month | 20 | Day |
Last modified on
| 2022 | Year | 06 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028520
| Research Plan | |
|---|---|
| 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 |
