UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000051476
Receipt number R000058720
Scientific Title Needs assessment of inpatients in rehabilitation wards
Date of disclosure of the study information 2023/06/28
Last modified on 2023/06/28 23:49:24

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Basic information

Public title

Needs assessment of inpatients in rehabilitation wards

Acronym

Needs assessment of inpatients in rehabilitation wards

Scientific Title

Needs assessment of inpatients in rehabilitation wards

Scientific Title:Acronym

Needs assessment of inpatients in rehabilitation wards

Region

Japan


Condition

Condition

cerebrovascular disease, musculoskeletal disease, etc.
The diseases eligible for admission to the convalescent rehabilitation wards.

Classification by specialty

Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To determine the nature of the needs and the degree of agreement between patients, their families, and health care providers during their stay in the rehabilitation unit using a structured questionnaire based on items from the International Classification of Functioning, Disability and Health (ICF), an international model of functioning in life.

Basic objectives2

Others

Basic objectives -Others

To identify what patients, their families, and health care providers consider to be the needs of patients in rehabilitation units and the degree of concordance between these needs.

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

(Examination 1)
Results of the interview survey
(Examination 2)
The agreement rate of each item between patient-family, patient-provider, and family-provider.

Key secondary outcomes



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

16 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

(Examination 1)
Patients (16 years of age or older) admitted to the Rehabilitation Ward of Fujita Medical University Hospital who have no judgment problems in answering the questionnaire and who are able to understand the text and who can give informed consent for this study, and therapists (physical therapists, occupational therapists) enrolled in the Rehabilitation Ward of Fujita Medical University Hospital will be included in the study. The study will be conducted in the rehabilitation ward of Fujita Medical University Hospital.

(Examination 2)
Patients (16 years of age or older) admitted to the Rehabilitation Ward of Fujita Medical University Hospital who have no judgmental problems in answering the questionnaire and who are able to understand the text and who can give informed consent for this study, their family members, and physical and occupational therapists in charge of the patients who are the subjects of the study will be included in the study. The target population is physical therapists and occupational therapists in charge of the patients who are the subjects of the study.

Key exclusion criteria

(Examination 1)
Patients whose responses to the interview were judged by the therapist in charge to be mentally burdensome

(Examination 2)
Patients whose responses to the questionnaire were judged to be mentally burdensome by the study's investigator.
Patients whose family members were not present at the time of admission

Target sample size

421


Research contact person

Name of lead principal investigator

1st name Yohei
Middle name
Last name Otaka

Organization

Fujita Health University

Division name

Department of Rehabilitation Medicine I

Zip code

4701192

Address

1-98 Dengakugakubo, Kutsukake, Toyoake, Aichi 470-1192, Japan

TEL

0562-93-2167

Email

rehab@fujita-hu.ac.jp


Public contact

Name of contact person

1st name Yohei
Middle name
Last name Otaka

Organization

Fujita Health University School of Medicine

Division name

Department of Rehabilitation Medicine I

Zip code

4701192

Address

1-98, Dengakugakubo, Kutsukake-cho, Toyoake, Aichi

TEL

0562-93-2167

Homepage URL


Email

rehab@fujita-hu.ac.jp


Sponsor or person

Institute

Fujita Health University

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Ethics Review Committee of Fujita Health University

Address

1-98 Dengakugakubo, Kutukake-cho, Toyoake, Aichi

Tel

0562-93-2865

Email

f-irb@fujita-hu.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

藤田医科大学病院(愛知県)


Other administrative information

Date of disclosure of the study information

2023 Year 06 Month 28 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

2023 Year 02 Month 07 Day

Date of IRB

2023 Year 04 Month 20 Day

Anticipated trial start date

2023 Year 06 Month 28 Day

Last follow-up date

2026 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

To investigate, using qualitative methods, the perceived needs of patients admitted to the rehabilitation unit, their families and the medical staff in charge.


Management information

Registered date

2023 Year 06 Month 28 Day

Last modified on

2023 Year 06 Month 28 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058720


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name