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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000022968
Receipt No. 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

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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
Email 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
Email hoisan@ncgg.go.jp

Sponsor
Institute National Center for Geriatrics and Gerontology
Endocrinology, Diabetes and Metabolism
Institute
Department

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
Email

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
URL(English) https://upload.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


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