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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000025338
Receipt No. 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 2017/12/21

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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
Email 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
Email matsuguma@keio.jp

Sponsor
Institute Keio University School of Medicine
Department of ophthalmology
Institute
Department

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
Email

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 Open public recruiting
Date of protocol fixation
2016 Year 10 Month 19 Day
Date of IRB
Anticipated trial start date
2016 Year 11 Month 17 Day
Last follow-up date
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
2017 Year 12 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028520

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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