UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047630 |
|---|---|
| Receipt number | R000054178 |
| Scientific Title | Understanding the psychological QoL of patients with locked-in syndrome: a scoping review |
| Date of disclosure of the study information | 2022/04/30 |
| Last modified on | 2023/04/30 09:07:35 |
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Basic information
Public title
Understanding the psychological QoL of patients with locked-in syndrome:
a scoping review
Acronym
Understanding the psychological QoL of patients with locked-in syndrome:
a scoping review
Scientific Title
Understanding the psychological QoL of patients with locked-in syndrome:
a scoping review
Scientific Title:Acronym
Understanding the psychological QoL of patients with locked-in syndrome:
a scoping review
Region
| Japan |
Condition
Condition
Locked-in syndrome caused by neurological disease, such as ALS
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This review aims to understand the actual psychological well-being of LIS patients and also identify the gaps in knowledge regarding this state.
Basic objectives2
Others
Basic objectives -Others
Psychological status-QoL
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
the actual psychological well-being of LIS patients
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 10 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
We will search the following database, MEDLINE, PubMed, Cochrane and Embase related to the psychological well-being of Locked-in syndrome published within the last 30 years. Search terms will include ("Locked-in syndrome" OR "Locked-in state") AND ("Quality of life" OR "well-being" OR "psychological"). The search includes any kind of articles with human subjects, and written in the English languages. Consequently, we will include articles with the following characteristics. 1) Population: patients with Locked-in syndrome; 2) Concept: evaluation of psychological well-being for patients with Locked-in syndrome and explore the elements influencing it, such as country of origin; 3) Context: psychological well-being, such as mental wellness, anxiety, depression, autonomy, isolation or suicidal ideation must be included in the outcome of articles
Key exclusion criteria
experimental intervention studies, such as brain-computer interface are excluded because it might make it difficult to interpret the QoL in general LIS patients.
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Yoshiki |
Organization
St Luke's International University
Division name
Graduate school of public health
Zip code
1040044
Address
10-1, Akashi-cgo, Chuo-ku, Tokyo 104-0044, Japan
TEL
03-3543-6391
hiroshiyoshiki141@gmail.com
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | Yoshiki |
Organization
St Luke's International University
Division name
Graduate school of public health
Zip code
1040044
Address
10-1, Akashi-cgo, Chuo-ku, Tokyo 104-0044, Japan
TEL
03-3545-6391
Homepage URL
hiroshiyoshiki141@gmail.com
Sponsor or person
Institute
St Luke's International University
Institute
Department
Personal name
Funding Source
Organization
self funding
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
St Luke's International University
Address
10-1, Akashi-cgo, Chuo-ku, Tokyo 104-0044, Japan
Tel
03-3543-6391
hiroshiyoshiki141@gmail.com
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
| 2022 | Year | 04 | Month | 30 | 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
| 2022 | Year | 04 | Month | 17 | Day |
Date of IRB
| 2022 | Year | 04 | Month | 17 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 17 | Day |
Last follow-up date
| 2022 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 05 | Month | 31 | Day |
Date trial data considered complete
| 2022 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2022 | Year | 08 | Month | 31 | Day |
Other
Other related information
This study aims to understand the actual psychological QoL of Locked-in syndrome patients based on a comprehensive evaluation of the available evidence produced on this topic to date. It will identify the gaps in knowledge and inform which areas may required further research or development. This scoping review may serve as a precursor to a more targeted systematic review in the future and offer us a general understanding of the correct perception regarding the Locked-in syndrome state to caregivers and relatives. In addition, the findings could improve the LIS patient's situation by accelerating the development of communication device for patients with LIS.
Management information
Registered date
| 2022 | Year | 04 | Month | 30 | Day |
Last modified on
| 2023 | Year | 04 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054178
