UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035203 |
|---|---|
| Receipt number | R000040124 |
| Scientific Title | Exploring the meaning of symptom and dysfunction to patients with osteoarthritis of the knee: a qualitative study |
| Date of disclosure of the study information | 2018/12/11 |
| Last modified on | 2024/01/11 16:37:38 |
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Basic information
Public title
Exploring the meaning of symptom and dysfunction to patients with osteoarthritis of the knee: a qualitative study
Acronym
Exploring the meaning of symptom and dysfunction to patients with osteoarthritis of the knee
Scientific Title
Exploring the meaning of symptom and dysfunction to patients with osteoarthritis of the knee: a qualitative study
Scientific Title:Acronym
Exploring the meaning of symptom and dysfunction to patients with osteoarthritis of the knee
Region
| Japan |
Condition
Condition
Osteoarthritis of the knee
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to investigate how patients with osteoarthritis of the knee think about their symptoms and dysfunctions and how they deal with them.
Basic objectives2
Others
Basic objectives -Others
Exploratory
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Data from interview
Key secondary outcomes
Base
Study type
Observational
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
| 50 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with osteoarthritis of the knee
Key exclusion criteria
People those who is difficult to communicate by conversation
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Daisuke |
| Middle name | |
| Last name | Uritani |
Organization
Kio University
Division name
Faculty of Health Science
Zip code
6580832
Address
4-2-2 Umaminaka Koryocho Kitakatsuragigun Nara
TEL
0745541601
d.uritani@kio.ac.jp
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | Nakayama |
Organization
Kio University
Division name
the general affairs department
Zip code
6350832
Address
4-2-2 Umaminaka Koryocho Kitakatsuragigun Nara
TEL
0745541601
Homepage URL
h.nakayama@kio.ac.jp
Sponsor or person
Institute
Kio University
Institute
Department
Personal name
Funding Source
Organization
Kio University
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
Kio University
Address
4-2-2 Umaminaka Koryocho Kitakatsuragigun Nara
Tel
0745541601
soumu@kio.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
| 2018 | Year | 12 | Month | 11 | Day |
Related information
URL releasing protocol
https://bmcmusculoskeletdisord.biomedcentral.com/articles/10.1186/s12891-021-04641-7
Publication of results
Published
Result
URL related to results and publications
https://bmcmusculoskeletdisord.biomedcentral.com/articles/10.1186/s12891-021-04641-7
Number of participants that the trial has enrolled
9
Results
Two core categories were extracted from the interview data 'Negative experiences' and 'Coping with difficulties'. Japanese patients with knee osteoarthritis (OA) desired evidence-based information and to connect with other people in the same situation to solve problems related to their condition.
Results date posted
| 2024 | Year | 01 | Month | 11 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Nine patients (2 men and 7 women; mean age, 74.3 years) with knee OA.
Participant flow
Study participants comprised patients with knee OA from different regions in Japan.
Purposive sampling according to the inclusion criteria determined by the research purpose was performed to obtain rich, relevant, and diverse data pertinent to the research question.
Adverse events
None
Outcome measures
None
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 12 | Month | 10 | Day |
Date of IRB
| 2018 | Year | 12 | Month | 13 | Day |
Anticipated trial start date
| 2018 | Year | 12 | Month | 20 | Day |
Last follow-up date
| 2021 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Interview survey from participants
Management information
Registered date
| 2018 | Year | 12 | Month | 10 | Day |
Last modified on
| 2024 | Year | 01 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040124
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
