UMIN-CTR Clinical Trial

Public title

A study on the impact on efficiency/convenience of patient guidance and effectiveness of guidance by a food record application.

Acronym

Examination of meal recording applications and their convenience and usefulness

Scientific Title

A study on the impact on efficiency/convenience of patient guidance and effectiveness of guidance by a food record application.

Scientific Title:Acronym

Examination of meal recording applications and their convenience and usefulness

Region

Japan

Condition

Diabetes mellitus

Classification by specialty

Endocrinology and Metabolism

Not applicable

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The use of IT in healthcare has been remarkable. One of the most recent advances is the use of dietary intake apps for patients before the onset of disease from the perspective of preventive medicine. However, for nutritional treatment after the onset of disease, there have been few cases of using food intake apps because they are not covered by insurance. In recent years, due to reforms in work styles, healthcare professionals are required to shorten working hours and improve work efficiency, and we thought that utilizing a dietary intake app for patient education would not only improve patient education, but also reduce the burden on healthcare professionals. Therefore, this study will determine whether nutritional prescriptions in the app will improve the efficiency/convenience of patient education among professions (dietitians and pharmacists) and facilities (hospitals and family pharmacies).
We will also examine whether the combined use of a food intake app and nutritional guidance has an impact on patient understanding of nutritional therapy at the time of discharge and implementation of nutritional therapy after discharge.

Basic objectives2

Others

Basic objectives -Others

This study will examine the possibility of reducing the burden on healthcare professionals through the use of the application.

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

Improved business efficiency and convenience through application use for medical professionals after 1 month

Key secondary outcomes

Impact of app use on understanding of treatment for inpatients)
Impact of the app on adherence to indicated nutritional therapy for discharged patients
Effect of app utilization on weight and HbA1c for discharged patients
patient)

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -participants are blinded

Control

No treatment

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

No need to know

No. of arms

2

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Other

Interventions/Control_1

Intervention group
During the hospitalization period (about 10 days) and for 3 months after discharge, the patients will be divided into two groups: one group will use the food record application and the other group will not use the application. Normal nutritional counselling will be provided as is.
Questionnaires will be administered at the time of discharge, one month after discharge, and three months after discharge.

Interventions/Control_2

Control group
The control group will receive only regular ward nutritional guidance, be observed during hospitalization and three months after discharge, and be asked to complete a questionnaire.
Questionnaires will be administered at the time of discharge, one month after discharge, and three months after discharge.

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

75

years-old

>

Gender

Male and Female

Key inclusion criteria

(1) Diabetic patients admitted to the Department of Endocrinology/Metabolism/Diabetes at Fujita Medical University Hospital and attending their family physician after discharge
1) Patients who have given a full explanation of their participation in this study, and who have given written consent of their own free will based on a thorough understanding of the study.
2. patients who are between 20 and 75 years old at the time of consent
3. patients who have a cell phone model that can use the mobile application and who can download and operate the application
4. patients who are willing to receive nutritional counseling (and medication guidance if they receive their prescriptions at Sugi Pharmacy) by answering the questionnaire at Sugi Pharmacy in the first and third months after discharge from the hospital
5. those who are willing to provide Sugi Pharmacy with their contact information for communication purposes.
(The contact information will not be used for any other purpose than to contact the patient for this study.)
2. medical personnel (dietitian, pharmacist) who will deal with the patients

Key exclusion criteria

1. those who cannot use the application
2. for the purpose of preoperative blood glucose control for surgery
3. other patients deemed inappropriate by the principal investigator or principal study author

Target sample size

60

Name of lead principal investigator

1st name	katsumi
Middle name
Last name	Iizuka

Organization

Fujita Health University

Division name

The department of Clinical Nutrition

Zip code

470-1192

Address

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

TEL

0562-93-2329

Email

katsumi.iizuka@fujita-hu.ac.jp

Name of contact person

1st name	Katsumi
Middle name
Last name	Iizuka

Organization

Fujita Health University

Division name

The Department of Clinical Nutrition

Zip code

470-1192

Address

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

TEL

0562-93-2329

Homepage URL

Email

katsumi.iizuka@fujita-hu.ac.jp

Institute

Fujita health university

Institute

Department

Personal name

Organization

Fujita health university

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

fujita

Address

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

Tel

0562-93-2865

Email

f-irb@fujita-hu.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

藤田医科大学病院

Date of disclosure of the study information

2022

Year

07

Month

27

Day

URL releasing protocol

https://www.clin-nutr.med.fujita-hu.ac.jp

Publication of results

Unpublished

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

Recruitment status

Terminated

Date of protocol fixation

2022

Year

07

Month

22

Day

Date of IRB

2022

Year

07

Month

22

Day

Anticipated trial start date

2022

Year

09

Month

14

Day

Last follow-up date

2024

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2022

Year

07

Month

27

Day

Last modified on

2023

Year

10

Month

16

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055249