UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051788 |
|---|---|
| Receipt number | R000058829 |
| Scientific Title | The Effect of Online App Connections on Physical Activity. |
| Date of disclosure of the study information | 2023/08/02 |
| Last modified on | 2023/08/02 01:38:56 |
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Basic information
Public title
The Effect of Online App Connections on Physical Activity.
Acronym
The Effect of Online App Connections on Physical Activity.
Scientific Title
The Effect of Online App Connections on Physical Activity.
Scientific Title:Acronym
The Effect of Online App Connections on Physical Activity.
Region
| Japan |
Condition
Condition
Type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the effects of an online application that groups medical staff and patients with type 2 diabetes on physical activity.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Average number of steps per day at 12 and 24 weeks from the time of consent to participate in this study
Social capital at the time of consent to participate in this study and after 12 and 24 weeks
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Use of group-based applications on smartphones capable of measuring steps
Interventions/Control_2
Use of applications on smartphones capable of measuring steps
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Type 2 diabetic patients visiting Toyooka Public Hospital for diabetes outpatient
2. Use a smartphone on a daily basis.
Key exclusion criteria
1. Patients with orthopedic conditions that make walking difficult or diabetic complications that are not amenable to exercise
2. Have other serious medical conditions that limit walking and exercise
3. Patients who cannot carry a smartphone for work or other reasons
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | SHOHEI |
| Middle name | |
| Last name | NISHIDA |
Organization
Toyooka Public Hospital
Division name
Department of Rehabilitation
Zip code
668-8501
Address
1094, Tobera, Toyooka-shi, HYOGO
TEL
0796-22-6111
s314nsds@gmail.com
Public contact
Name of contact person
| 1st name | SHOHEI |
| Middle name | |
| Last name | NISHIDA |
Organization
Toyooka public Hospital
Division name
Department of Rehabilitation
Zip code
668-8501
Address
1094, Tobera, Toyooka-shi, HYOGO
TEL
0796-22-6111
Homepage URL
s314nsds@gmail.com
Sponsor or person
Institute
Toyooka Public Hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Toyooka Public Hospital
Address
1094, Tobera, Toyooka-shi, HYOGO
Tel
0796-22-6111
s314nsds@gmail.com
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 | 08 | Month | 02 | 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
| 2022 | Year | 06 | Month | 05 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 10 | Day |
Anticipated trial start date
| 2023 | Year | 08 | Month | 03 | Day |
Last follow-up date
| 2024 | Year | 06 | Month | 01 | 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 | 08 | Month | 02 | Day |
Last modified on
| 2023 | Year | 08 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058829
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
