UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000028643
Receipt number R000030254
Scientific Title Self-care support intervention focusing on living environments.
Date of disclosure of the study information 2017/09/01
Last modified on 2018/09/18 15:47:16

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Basic information

Public title

Self-care support intervention focusing on living environments.

Acronym

Self-care support intervention focusing on living environments.

Scientific Title

Self-care support intervention focusing on living environments.

Scientific Title:Acronym

Self-care support intervention focusing on living environments.

Region

Japan


Condition

Condition

Diabetes

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate efficacy of self-care support intervention focusing on living environments.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Score of the Summary of Diabetes Self-Care Activities Measure

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


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Behavior,custom

Interventions/Control_1

Self-care support intervention suggesting what to buy or what to order based on the information of the shops or restaurants easily available for each patient.

Interventions/Control_2

conventional self-care support

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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients with poor control (HbA1c>=8% for more than 3 months)

Key exclusion criteria

Patients treated less than 1 year
Patients hard to answer self-reported questionnaire

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kaori Ikeda

Organization

Kyoto University Hospital

Division name

Diabetes, Endocrinology and Clinical Nutrition

Zip code


Address

54 Kawaharacho, Shogoin, Sakyo-ku Kyoto

TEL

075-751-3560

Email

krikeda@kuhp.kyoto-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Kaori Ikeda

Organization

Kyoto University Hospital

Division name

Diabetes, Endocrinology and Clinical Nutrition

Zip code


Address

54 Kawaharacho, Shogoin, Sakyo-ku Kyoto

TEL

075-751-3560

Homepage URL


Email

krikeda@kuhp.kyoto-u.ac.jp


Sponsor or person

Institute

Kyoto University

Institute

Department

Personal name



Funding Source

Organization

Japan Society for the Promotion of Science

Organization

Division

Category of Funding Organization

Japanese Governmental office

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



Other administrative information

Date of disclosure of the study information

2017 Year 09 Month 01 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

Terminated

Date of protocol fixation

2017 Year 08 Month 11 Day

Date of IRB


Anticipated trial start date

2017 Year 09 Month 11 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

2017 Year 08 Month 11 Day

Last modified on

2018 Year 09 Month 18 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030254


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name