UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055512 |
|---|---|
| Receipt number | R000063434 |
| Scientific Title | A Systematic Review and Meta-Analysis of the Effectiveness of Occupational Therapy for Patients with Early Stage Rheumatoid Arthritis |
| Date of disclosure of the study information | 2024/09/16 |
| Last modified on | 2024/09/16 16:05:21 |
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Basic information
Public title
A Systematic Review and Meta-Analysis of the Effectiveness of Occupational Therapy for Patients with Early Stage Rheumatoid Arthritis
Acronym
A Literature Review of the Effectiveness of Occupational Therapy for Patients with Early Stage Rheumatoid Arthritis
Scientific Title
A Systematic Review and Meta-Analysis of the Effectiveness of Occupational Therapy for Patients with Early Stage Rheumatoid Arthritis
Scientific Title:Acronym
A Systematic Review and Meta-Analysis of the Effectiveness of Occupational Therapy for Patients with Early Stage Rheumatoid Arthritis
Region
| Japan |
Condition
Condition
Rheumatoid arthritis
Classification by specialty
| Clinical immunology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the effectiveness of occupational therapy for patients with early-stage rheumatoid arthritis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Health Assesment Questionnaire (HAQ)
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Studies in which occupational therapy is provided to people within 2 years of being diagnosed with rheumatoid arthritis
Key exclusion criteria
Studies involving people who have been diagnosed with rheumatoid arthritis for at least 2 years
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Shogo |
| Middle name | |
| Last name | Maeda |
Organization
Miyazaki University Hospital
Division name
Department of Rehabilitation
Zip code
8891692
Address
5200 Kihara, Kiyotake-cho, Miyazaki City, Miyazaki Prefecture
TEL
0985851510
shougo_maeda@med.miyazaki-u.ac.jp
Public contact
Name of contact person
| 1st name | shogo |
| Middle name | |
| Last name | maeda |
Organization
Miyazaki University Hospital
Division name
Department of Rehabilitation
Zip code
889-1692
Address
5200 Kihara, Kiyotake-cho, Miyazaki City, Miyazaki Prefecture
TEL
0985851510
Homepage URL
shougo_maeda@med.miyazaki-u.ac.jp
Sponsor or person
Institute
Miyazaki University Hospital,Department of Rehabilitation,Shogo Maeda
Institute
Department
Personal name
Funding Source
Organization
Miyazaki University Hospital,Department of Rehabilitation,Shogo Maeda
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
Miyazaki University Hospital
Address
5200 Kihara, Kiyotake-cho, Miyazaki City, Miyazaki Prefecture
Tel
0985851510
shougo_maeda@med.miyazaki-u.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
| 2024 | Year | 09 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 09 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 09 | Month | 16 | Day |
Last follow-up date
| 2028 | Year | 09 | Month | 16 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
In accordance with the PRISMA statement, the search formula was Patient: early rheumatoid arthritis, Intervention: Occupational Therapy, using the search sites of Medical Journal, PubMed, MEDLINE, CINAHL, and Cochrane Library. Occupational Therapy) (Control and Outcome were not set because of the expected low number of searches), and articles were screened. Screening was conducted by two persons: one certified occupational therapist and registered rheumatology therapist and one rheumatologist.
The primary outcome was the Health Assessment Questionnaire (AQ), and secondary outcomes were grip strength and Visual Analog Scale (VAS).
Statistical analyses were conducted using Review Manager 5 to calculate estimates of standardized mean differences (95% confidence intervals) and P values for effect sizes in a variable effects model for each outcome (significance levels were less than 5%). Statistical heterogeneity of each outcome was also evaluated. Subsequently, in a subgroup analysis, we calculated the estimated standardized mean difference (95% confidence interval) and P value of the effect size for each outcome in a variable effects model, separately for each intervention (significance level was less than 5%).
Management information
Registered date
| 2024 | Year | 09 | Month | 16 | Day |
Last modified on
| 2024 | Year | 09 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063434
