臨床研究等提出・公開システム

Date of registration	Oct. 22, 2024
Last modified on	Oct. 22, 2024
Trial ID	jRCT1030240425

Scientific Title	A pilot study of a care program for people with type 2 diabetes who Discontinue Consult a Doctor
Public Title	A pilot study of a care program for people with type 2 diabetes

Contact for Scientific Queries	Name	Akiko Yoneda
	Affiliation	Yamanashi Prefectural University
	Address	1-6-1 Ikeda Kofu-shi Yamanashi-prefecture 400 -0062
	Telephone	+81-9078113008
	E-mail	yonedaok@yamanashi-ken.ac.jp
Contact for Public Queries	Name	Akiko Yoneda
	Affiliation	Yamanashi Prefectural University
	Address	1-6-1 Ikeda Kofu-shi Yamanashi-prefecture 400-0062
	Telephone	+81-9078113008
	E-mail	yonedaok@yamanashi-ken.ac.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		Oct. 22, 2024
Actual date of first enrollment		April. 06, 2024
Target sample size		6
Study Type		Observational
Key inclusion & exclusion criteria	Inclusion Criteria	Men aged 30 to 70 years who have been diagnosed with type 2 diabetes and have had a treatment interruption period of 6 months or more, and who have agreed to participate in this study
	Exclusion Criteria	Patients who meet any of the following criteria will be excluded from the study: Receiving dialysis Receiving cancer treatment Diagnosed with dementia Residing in a nursing home Having difficulty communicating and responding to the questionnaire History of blindness or lower limb amputation (major amputation) (At the time of recruitment) Unemployed (At the time of recruitment) HbA1c (hemoglobin A1c: an index of blood glucose level) less than 6% (At the time of recruitment) HbA1c 10% or more and positive urine ketones (At the time of recruitment) Persistent urine ketones
	Age Minimum	30age old over
	Age Maximum	70age old not
	Gender	Male
Health Condition(s) or Problem(s) Studied		Type 2 diabetes
Health Condition(s) Keyword		Type 2 diabetes
Primary Outcome(s)		Care program completion rate (up to care 7)
Secondary Outcome(s)		HbA1c Blood glucose level Visiting situation Self-care ability QOL Blood pressure BMI Implementation status of care program Opinions and impressions regarding care program intervention

Primary Sponsor	Akiko Yoneda

Secondary Sponsor

Source of Monetary Support	Japan Society for The Promotion of Science Grants-in-Aid for Scientic Research
Secondary Sponsor	Applicable

Name of Certified Review Board	Yamanashi Prefectural University Faculty of Nursing Research Ethics Committee
Address	1-6-1 Ikeda, Kofu City, Yamanashi
Telephone	+81-552539445
E-Mail	yonedaok@yamanashi-ken.ac.jp
Approval Status	Approval
Date of approval	Feb. 09, 2024

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none