UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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
Title of the study (Brief 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
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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Sayuri Sable-Morita
Organization	National Center for Geriatrics and Gerontology
Division name	Nursing Department
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	Takahisa Tanikawa
Organization	National Center for Geriatrics and Gerontology
Division name	Endocrinology, Diabetes and Metabolism
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

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2016 Year 03 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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