UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058818 |
|---|---|
| Receipt number | R000067261 |
| Scientific Title | Understanding the Effects of a Management Tool for Daily Life Performance using Mixed Methods |
| Date of disclosure of the study information | 2025/08/17 |
| Last modified on | 2025/08/17 14:51:01 |
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Basic information
Public title
Understanding the Effects of a Management Tool for Daily Life Performance using Mixed Methods
Acronym
Understanding the Effects of a Management Tool for Daily Life Performance using Mixed Methods
Scientific Title
Understanding the Effects of a Management Tool for Daily Life Performance using Mixed Methods
Scientific Title:Acronym
Understanding the Effects of a MTDLP using Mixed Methods
Region
| Japan |
Condition
Condition
Participants receiving occupational therapy who have had, are having, or will have interventions using Management Tool for Daily Life Performance (MTDLP).
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to clarify what medical support is necessary for continuing a preferred life by using a mixed research method by quantitative analysis of practice record data of individualized team medical treatment and qualitative analysis by interview after practice.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Interview content based on semi-structured interviews
Key secondary outcomes
(1) MTDLP Sheet ((1) General Information Sheet (2) Daily Life Performance Interview Sheet (3) Management Tool for Daily Life Performance Sheet (4) Daily Life Performance Analysis Sheet (5) Social Resources Information Sheet)
(2) Performance level, Degree of satisfaction
(3) Functional independence at the start of intervention and at the re-evaluation approximately three months later
Functional Independence Measure (FIM) or Barthel Index (BI)
(4) Assessment of physical and mental functions tailored to each disease characteristic at the start of intervention and at the three-month follow-up evaluation.
Examples for orthopedic diseases: Joint range of motion measurement, sensory function (Semmes-Weinstein Monofilaments test: SWME), grip strength, pinch strength, patient-reported outcomes (Quick The Disability of the Arm, Shoulder, and Hand: Q-DASH).
Examples for cerebrovascular disorders: Degree of motor paralysis (Fugl-Meyer Assessment: FMA), upper limb function assessment (Box and Block Test: BBT or Action Research Arm Test: ARAT), evaluation of the use of the paralyzed hand (Motor Activity Log: MAL), sensory function (SWME)
In addition to the examples listed above, this includes physical and mental function assessments that are typically conducted as part of occupational therapy evaluations and interventions for other diseases, and is not limited to the diseases and assessment items illustrated above.
(5) At the time of re-evaluation, the Global Rating of Change Scale (GROC) is used to assess the degree of improvement, no change, or deterioration on a 5-point scale.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Management Tool for Daily Life Performance Sheet (MTDLP)
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
| 1 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Participants receiving occupational therapy who have had, are having, or will have interventions using Management Tool for Daily Life Performance (MTDLP).
Key exclusion criteria
Participants with a clear lack of decision-making skills (Cognitive decline, impaired consciousness) that makes it difficult to understand and agree with the study description.
Participants with acute deterioration at the start of the study (unless the attending physician individually determined that occupational therapy and the study were acceptable).
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | YUINE |
Organization
Ibaraki Prefectural University of Health Sciences
Division name
Department of Occupational Therapy
Zip code
300-0394
Address
4669-2 Ami, Ami-machi, Inashiki-gun, Ibaraki
TEL
0298402220
yuinehi@ipu.ac.jp
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | YUINE |
Organization
Ibaraki Prefectural University of Health Sciences
Division name
Department of Occupational Therapy
Zip code
300-0394
Address
4669-2 Ami, Ami-machi, Inashiki-gun, Ibaraki
TEL
0298402220
Homepage URL
yuinehi@ipu.ac.jp
Sponsor or person
Institute
Ibaraki Prefectural University of Health Sciences
Institute
Department
Personal name
Funding Source
Organization
Ibaraki Prefectural University of Health Sciences
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ibaraki Prefectural University of Health Sciences Institutional Review Board
Address
4669-2 Ami, Ami-machi, Inashiki-gun, Ibaraki
Tel
029-840-4000
yuinehi@ipu.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
| 2025 | Year | 08 | Month | 17 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 06 | Month | 18 | Day |
Date of IRB
| 2025 | Year | 06 | Month | 20 | Day |
Anticipated trial start date
| 2025 | Year | 08 | Month | 19 | Day |
Last follow-up date
| 2031 | 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
| 2025 | Year | 08 | Month | 17 | Day |
Last modified on
| 2025 | Year | 08 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067261
