UMIN-CTR Clinical Trial

Basic information
Public title	The survey for the usefulness and problems of telephone-based outpatient clinic for orthopedic disease
Acronym	The survey for the usefulness of telephone-based outpatient clinic for orthopedic disease
Scientific Title	The survey for the usefulness of telephone-based outpatient clinic for orthopedic disease
Scientific Title:Acronym	The survey for the usefulness of telephone-based outpatient clinic for orthopedic disease
Region	Japan

Condition
Condition	Orthopedic disease (especially for spinal disease)
Classification by specialty	Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine the improvement of patient clinical symptoms, patient satisfaction and any problems for telephone-based outpatient clinic when compared with face-to-face treatment
Basic objectives2	Others
Basic objectives -Others	To examine medical staff satisfaction and any kinds of difficulty
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Patients' clinical outcome and patient satisfaction
Key secondary outcomes	medical staff satisfaction, any kinds of problem related telemedicine

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	20 years-old <=
Age-upper limit	99 years-old >=
Gender	Male and Female
Key inclusion criteria	The patients with orthopedic diseases who received telephone-based outpatient clinic
Key exclusion criteria	The patients who do not agree with the prescribed opt-out The patients who are in postoperative acute phase and hard to receive telephone-based medicine
Target sample size	400

Research contact person
Name of lead principal investigator	1st name Toru Middle name Last name Tanaka
Organization	Osaka City Juso Hospital
Division name	Department of orthopedic surgery
Zip code	5320034
Address	2-12-27, Nonakakita, Yodogawa-ku, Osaka
TEL	0661508000
Email	kh_ocg@yahoo.co.jp

Public contact
Name of contact person	1st name Kazunori Middle name Last name Hayashi
Organization	Osaka City Juso Hospital
Division name	Department of orthopedic surgery
Zip code	5320034
Address	2-12-27, Nonakakita, Yodogawa-ku, Osaka
TEL	0661508000
Homepage URL
Email	kh_ocg@yahoo.co.jp

Sponsor
Institute	Osaka City Juso Hospital
Institute
Department

Funding Source
Organization	self funding
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	109

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Osaka City Juso Hospital
Address	2-12-27, Nonakakita, Yodogawa-ku, Osaka
Tel	0661508000
Email	close to public

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	2020 Year 06 Month 15 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	Enrolling by invitation
Date of protocol fixation	2020 Year 05 Month 15 Day
Date of IRB	2020 Year 06 Month 15 Day
Anticipated trial start date	2020 Year 05 Month 15 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	Primary outcome: Clinical outcome measured by VAS and HRQoL and patients satisfaction Secondary outcome: Medical staff satisfaction, any kinds of problem related telemedicine

Management information
Registered date	2020 Year 06 Month 15 Day
Last modified on	2022 Year 02 Month 21 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046557