UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022968 |
|---|---|
| Receipt number | R000026478 |
| Scientific Title | An evaluation of the effectiveness of a multi-disciplinary intervention in older type 2 diabetes patients with pre-frailty or frailty : study protocol for a randomized controlled trial |
| Date of disclosure of the study information | 2016/07/04 |
| Last modified on | 2016/07/01 15:12:34 |
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Basic information
Public title
An evaluation of the effectiveness of a multi-disciplinary intervention in older type 2
diabetes patients with pre-frailty or frailty : study protocol for a randomized controlled
trial
Acronym
An evaluation of the effectiveness of a multi-disciplinary intervention in older type 2
diabetes patients with pre-frailty or frailty : study protocol for a randomized controlled
trial
Scientific Title
An evaluation of the effectiveness of a multi-disciplinary intervention in older type 2
diabetes patients with pre-frailty or frailty : study protocol for a randomized controlled
trial
Scientific Title:Acronym
An evaluation of the effectiveness of a multi-disciplinary intervention in older type 2
diabetes patients with pre-frailty or frailty : study protocol for a randomized controlled
trial
Region
| Japan |
Condition
Condition
Type 2 diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism | Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
An evaluation of the effectiveness of a multi-disciplinary intervention in older type 2
diabetes patients with pre-frailty or frailty
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The primary outcomes measured are pre-frailty or frailty at 3 and 12 months. They
are assessed using the OSHPE (Obu Study Health Promotion for the Elderly)'s criteria.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
YES
Institution consideration
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Participants receive the monthly core curriculum for 3 months.
The core curriculum consists of 3 components:
lecture on self-management,
individual nutrition counseling
and exercise training.
Interventions/Control_2
Participants receive the monthly lecture on self-management for 3 months.
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The subject fulfils the OSHPE's criteria for frailty or pre-frailty.
Key exclusion criteria
Mini Mental State Examination (MMSE) score less than 18 points
Cancer bearing
Terminal illness (life expectancy <12 months)
Severe diabetes microvascular complications (skin ulcer, active fundal hemorrhage
or end-stage renal disease)
Target sample size
180
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Sayuri Sable-Morita |
Organization
National Center for Geriatrics and Gerontology
Division name
Nursing Department
Zip code
Address
7-430 Morioka, Obu, Aichi, Japan 474-8511
TEL
0562-46-2311
mme.sayu@ncgg.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takahisa Tanikawa |
Organization
National Center for Geriatrics and Gerontology
Division name
Endocrinology, Diabetes and Metabolism
Zip code
Address
7-430 Morioka, Obu, Aichi, Japan 474-8511
TEL
0562-46-2311
Homepage URL
hoisan@ncgg.go.jp
Sponsor or person
Institute
National Center for Geriatrics and Gerontology
Endocrinology, Diabetes and Metabolism
Institute
Department
Personal name
Funding Source
Organization
National Center for Geriatrics and Gerontology
Endocrinology, Diabetes and Metabolism
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
Address
Tel
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
国立長寿医療研究センター(愛知県) National Center for Geriatrics and Gerontology
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 07 | Month | 04 | 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
| 2016 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 04 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 07 | Month | 01 | Day |
Last modified on
| 2016 | Year | 07 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026478
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
