UMIN-ICDS Clinical Trial

Unique ID issued by UMIN UMIN000052751
Receipt number R000060166
Scientific Title Usability evaluation of learning apps for people with chronic kidney disease
Date of disclosure of the study information 2023/11/10
Last modified on 2023/11/09 20:49:57

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Basic information

Public title

Usability evaluation of learning apps for people with chronic kidney disease

Acronym

Usability evaluation of learning apps for people with chronic kidney disease

Scientific Title

Usability evaluation of learning apps for people with chronic kidney disease

Scientific Title:Acronym

Usability evaluation of learning apps for people with chronic kidney disease

Region

Japan


Condition

Condition

Chronic kidney disease

Classification by specialty

Nephrology Nursing

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study was to conduct a usability evaluation by people with chronic kidney disease in order to obtain suggestions necessary for improving the learning app "Kidney App Three Choice Quiz" for people with chronic kidney disease.

Basic objectives2

Others

Basic objectives -Others

Usability

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Knowledge test before and after learning using the learning app "Kidney App Three Choice Quiz" for people with chronic kidney disease

Key secondary outcomes

Operation status of "Kidney App Three Choice Quiz", time required, and impressions after learning


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Self control

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Other

Interventions/Control_1

Learning using the learning app "Kidney App Three Choice Quiz" for people with chronic kidney disease

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

18 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

People over 18 years old who meet the following 1) and 2)
1) People with chronic kidney disease who were outpatients at the Department of Nephrology and Rheumatology, Gunma University Hospital, and who had not yet received renal replacement therapy.
2) Must have sufficient mobility in the upper limbs and fingers and visual acuity to operate a smartphone by tapping.

Key exclusion criteria

1) People with dementia or mental disorders.
2) People who have used this app.

Target sample size

38


Research contact person

Name of lead principal investigator

1st name Satsuki
Middle name
Last name Takahashi

Organization

Gunma University, Graduate School of Health Sciences

Division name

Department of Nursing

Zip code

371-8514

Address

3-39-22 Showa, Maebashi, Gunma

TEL

027-220-8819

Email

satsukit@gunma-u.ac.jp


Public contact

Name of contact person

1st name Sattsuki
Middle name
Last name Takahashi

Organization

Gunma University, Graduate School of Health Sciences

Division name

Department of Nursing

Zip code

371-8514

Address

3-39-22 Showa, Maebashi, Gunma

TEL

027-220-8819

Homepage URL


Email

satsukit@gunma-u.ac.jp


Sponsor or person

Institute

Gunma University, Graduate School of Health Sciences

Institute

Department

Personal name

Satsuki Takahashi


Funding Source

Organization

JSPS KAKENHI

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

Gunma University Ethical Review Board for Medical Research Involving Human Subjects

Address

3-39-15 Showa, Maebashi, Gunma

Tel

027-220-8740

Email

hitotaisho-ciru@ml.gunma-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

2023 Year 11 Month 10 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 11 Month 01 Day

Date of IRB

2023 Year 11 Month 01 Day

Anticipated trial start date

2024 Year 01 Month 15 Day

Last follow-up date

2028 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

2023 Year 11 Month 09 Day

Last modified on

2023 Year 11 Month 09 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060166


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name