UMIN-CTR Clinical Trial

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
Email	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
Email	chika01@med.tottori-u.ac.jp

Sponsor
Institute	Tottori university
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000031036