UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000040773
Receipt number R000046557
Scientific Title The survey for the usefulness of telephone-based outpatient clinic for orthopedic disease
Date of disclosure of the study information 2020/06/15
Last modified on 2022/02/21 20:52:23

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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 or person

Institute

Osaka City Juso Hospital

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046557


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name