UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046795 |
|---|---|
| Receipt number | R000053389 |
| Scientific Title | Verification of the effectiveness of the web-based education program for Japanese people with knee osteoarthritis |
| Date of disclosure of the study information | 2022/02/01 |
| Last modified on | 2022/08/04 08:32:11 |
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Basic information
Public title
Verification of the effectiveness of the web-based education program for Japanese people with knee osteoarthritis
Acronym
The effectiveness of the web-based education program for people with knee osteoarthritis
Scientific Title
Verification of the effectiveness of the web-based education program for Japanese people with knee osteoarthritis
Scientific Title:Acronym
The effectiveness of the web-based education program for people with knee osteoarthritis
Region
| Japan |
Condition
Condition
Osteoarthritis of the knee
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the short-term and long-term effects of a web-based 3-month patient education program on improving knee pain and physical activity in Japanese people with osteoarthritis of the knee .
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pain at posttest (after 3 month-intervention) and 6 month after posttest
Key secondary outcomes
Amount of Physical activity(average number of steps per day, pain at posttest and 6 month after posttest)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Web-based 3-month training program, information on knee osteoarthritis and education on physical activity, and regular remind message texts to encourage training and physical activity
Interventions/Control_2
Web-based information on knee osteoarthritis
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
| 45 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
if the individual
- is 45 years old or over and,
- has activity-related knee pain and,
- has no morning joint-related stiffness or has morning stiffness that lasts 30 minutes or less and,
- has had knee joint pain for more than 3 months.
- individual who has a smartphone, tablet, or computer that can receive text messages or emails.
- individual who has an internet environment in their home and can use the above devices.
Key exclusion criteria
if the Individual
- has undergone TKA/UKA or is waiting for TKA/UKA
- has rheumatoid arthritis or other inflammatory joint disease
- has diseases or disorders that affect knee pain or lower limb function other than knee osteoarthritis
- has participated in similar regular face-to-face or non-face-to-face exercise programs (including regular use of the training gym)
- does not have the permission of a doctor to participate in an unsupervised home exercise program
Target sample size
128
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
6350832
Address
4-2-2 Umaminaka Koryocho Kitakatsuragigun Nara
TEL
0745541601
d.uritani@kio.ac.jp
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Uritani |
Organization
Kio University
Division name
Faculty of Health Science
Zip code
6350832
Address
4-2-2 Umaminaka Koryocho Kitakatsuragigun Nara
TEL
0745541601
Homepage URL
d.uritani@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
| 2022 | Year | 02 | Month | 01 | 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
Open public recruiting
Date of protocol fixation
| 2022 | Year | 03 | Month | 31 | Day |
Date of IRB
| 2022 | Year | 04 | Month | 28 | Day |
Anticipated trial start date
| 2022 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2025 | 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 | 02 | Month | 01 | Day |
Last modified on
| 2022 | Year | 08 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053389
