UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027074 |
|---|---|
| Receipt number | R000031036 |
| Scientific Title | Effect of program for promotion of self-management practice based on instructional design for patients with knee osteoarthritis |
| Date of disclosure of the study information | 2017/05/08 |
| Last modified on | 2021/07/25 14:47:49 |
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Basic information
Public title
Effect of program for promotion of self-management practice based on instructional design for patients with knee osteoarthritis
Acronym
Effect of program for promotion of self-management practice based on instructional design for patients with knee osteoarthritis
Scientific Title
Effect of program for promotion of self-management practice based on instructional design for patients with knee osteoarthritis
Scientific Title:Acronym
Effect of program for promotion of self-management practice based on instructional design for patients with knee osteoarthritis
Region
| Japan |
Condition
Condition
Knee osteoarthritis
Classification by specialty
| Orthopedics | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this research is to identify a short term and long term effect of an intervention program for promotion of self-management practice based on instructional design for patients with knee osteoarthritis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
pain
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
workshop besed on instructional design
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Over 50 years of age at time of consent
2.Diagnosed with knee osteoarthritis and visiting a clinic
3.with 1-3 of Kellgren-Lawrence
4.with knee pain and difficulties on daily life
Key exclusion criteria
1.Comorbidities and complications such as severe myocardial infarction or stroke, and gangrene requiring hospitalization, with difficulty in completing surveys or participating during measurements
2.The person who will schedule an operation in the future
3.The person having the knee on in the past
4.Dementia or mental illness, with difficulty in completing surveys or participating during measurements
5.Pregnancy, or with incurable diseases of the musculoskeletal system, who have difficulty participating in measurements or cannot exercise
6.Others deemed inappropriate as participants for the study by the responsible physician
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Chika |
| Middle name | |
| Last name | Tanimura |
Organization
Tottori university
Division name
faculty of medicine
Zip code
683-8503
Address
86 Nishimachi, Yonago, Tottori,Japan
TEL
0859-38-6315
chika01@med.tottori-u.ac.jp
Public contact
Name of contact person
| 1st name | Chika |
| Middle name | |
| Last name | Tanimura |
Organization
Tottori university
Division name
faculty of medicine
Zip code
683-8503
Address
86 Nishimachi, Yonago, Tottori,Japan
TEL
0859-38-6315
Homepage URL
chika01@med.tottori-u.ac.jp
Sponsor or person
Institute
Tottori university
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
Tottori University
Address
86 Nishimachi, Yonago, Tottori,Japan
Tel
0859331111
chika01@tottori-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
| 2017 | Year | 05 | Month | 08 | 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
45
Results
Immediately after the intervention, self-confidence in self-management and self-management ability were improved, and the effect lasted until 3 months after the intervention. Immediately after the intervention, the difficulty in life was reduced immediately after the intervention, and the effect lasted until 3 months later. In addition, physical function and pain were improved.
Results date posted
| 2020 | Year | 04 | Month | 22 | Day |
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
No longer recruiting
Date of protocol fixation
| 2016 | Year | 08 | Month | 16 | Day |
Date of IRB
| 2016 | Year | 10 | Month | 04 | Day |
Anticipated trial start date
| 2017 | Year | 05 | Month | 13 | Day |
Last follow-up date
| 2021 | 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
| 2017 | Year | 04 | Month | 20 | Day |
Last modified on
| 2021 | Year | 07 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031036
