UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048681 |
|---|---|
| Receipt number | R000055433 |
| Scientific Title | Feasibility study of a post-stroke fatigue self-management program: examination of effects on patients with early fatigue |
| Date of disclosure of the study information | 2022/08/16 |
| Last modified on | 2023/08/16 09:46:55 |
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Basic information
Public title
Feasibility study of a post-stroke fatigue self-management program: examination of effects on patients with early fatigue
Acronym
Feasibility study of a post-stroke fatigue self-management program
Scientific Title
Feasibility study of a post-stroke fatigue self-management program: examination of effects on patients with early fatigue
Scientific Title:Acronym
Feasibility study of a post-stroke fatigue self-management program
Region
| Japan |
Condition
Condition
cerebral infarction, cerebral hemorrhage
Classification by specialty
| Neurology | Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
A post-stroke fatigue self-management program will be implemented for hospitalized patients with post-stroke fatigue (early fatigue). This study aims to clarify changes in fatigue, motivation and self-management of post-stroke fatigue post-intervention compared with pre-intervention and the feasibility of the program.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Multidimensional Fatigue Inventory-20: MFI-20
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
A researcher with a nursing license will administer a post-stroke fatigue self-management program, comprising 6 sessions over 2 weeks (14 days) to the participating patients, based on an intervention protocol.
The program is composed of three elements: education, support for self-monitoring and support for facilitating the problem-solving process.
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
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients who meet all nine of the following criteria will be eligible
1. A person who has had a stroke more than one week ago and has been determined by their attending physician to have completed acute stroke treatment
2. A person who has had a stroke within the preceding 3 months
3. A person who has been hospitalized in a convalescent rehabilitation ward or general ward for more than 3 days
4. A person who has suffered either cerebral infarction or cerebral hemorrhage
5. A person with a modified Rankin Scale score of 0 to 3
6. 20 years ole or older
7. A person with an expected hospitalization period of about 3 weeks
8. A person with post-stroke fatigue (early fatigue)
9. A person capable of voluntarily deciding whether to participate in the study
Key exclusion criteria
Patients who meet any of the following 4 criteria will be excluded
1. A person with recurrent stroke
2. A person with a diagnosis of depression
3. A person with cognitive impairment
4. A person with severe aphasia unable to communicate verbally or with severely impaired ability to read or write
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Mikiko |
| Middle name | |
| Last name | Sato |
Organization
The University of Shimane
Division name
Faculty of Nursing and Nutrition
Zip code
693-8550
Address
151 Nishihayashigi, Izumo-City, Shimane 693-8550, Japan
TEL
0853-20-0200
m-sato@u-shimane.ac.jp
Public contact
Name of contact person
| 1st name | Mikiko |
| Middle name | |
| Last name | Sato |
Organization
The University of Shimane
Division name
Faculty of Nursing and Nutrition
Zip code
693-8550
Address
151 Nishihayashigi, Izumo-City, Shimane 693-8550, Japan
TEL
0853-20-0200
Homepage URL
m-sato@u-shimane.ac.jp
Sponsor or person
Institute
The University of Shimane
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The University of Shimane
Address
151 Nishihayashigi, Izumo-City, Shimane 693-8550, Japan
Tel
0853200200
m-sato@u-shimane.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
| 2022 | Year | 08 | Month | 16 | 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 | 07 | Month | 19 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 19 | Day |
Anticipated trial start date
| 2022 | Year | 08 | Month | 22 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 08 | Month | 16 | Day |
Last modified on
| 2023 | Year | 08 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055433
