UMIN-CTR Clinical Trial

Public title

Development of Care Program to Support Live along with my Diabetes Mildly for patients with Type2 Diabetes who have not been visiting for treatment of Diabetes.

Acronym

Development of Care Program to Support Live along with my Diabetes Mildly for patients with Type2 Diabetes who have not been visiting for treatment of Diabetes.

Scientific Title

Development of Care Program to Support Live along with my Diabetes Mildly for patients with Type2 Diabetes who have not been visiting for treatment of Diabetes.

Scientific Title:Acronym

Development of Care Program to Support Live along with my Diabetes Mildly for patients with Type2 Diabetes who have not been visiting for treatment of Diabetes.

Region

Japan

Condition

2type diabetes melitus

Classification by specialty

Endocrinology and Metabolism

Nursing

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Consider the effect of intervention by a care program that helps Live along with My Diabetes Mildly to those who are diagnosed with type 2 diabetes that has a period when you are not seeking treatment for diabetes.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Primary outcomes

The assessment indicators of well beeing,selfcare ability is defined as a primary outcome and Shimizu and colleagues 2011 developed 40 elements of IDSCA,instrument of diabetes selfcare agency,developed by Orem theory based on the selfcare ability scale of diabetic patients we measure the selfcare ability with 5 elements of supportutilization power,application coordination power,the driving force of selfmanagement,the ability to selfmanage selfishly,body selfcognitive ability.

Key secondary outcomes

Secondary outcome is comprehensive health-related QOL scale standard version (SF-8) (Fukuhara, Suzukamo, 2004) and symptoms of chronic complications, Consultation symptom of hyperglycemia.

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

NO

Dynamic allocation

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Pseudo-randomization

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Maneuver

Other

Interventions/Control_1

Provide a care program to help prepare Live along with My Diabetes Mildly created by integrating the results of preliminary research aimed at interviews with people who have experienced discontinuation of diabetes treatment and previous studies.The care program includes seven care (care that respects the previous medical treatment method, interpretation of your diabetes myself, care to help you understand the appropriate medical regimen for yourself, care to help you acquire life skills to make your blood sugar harder to raise, Care to ease the recognition of excessive self management, care to help you to be able to borrow the power of others, care to help maintain relationships with people), in order to care gide Data are collected before intervention, twice during intervention, and one month after completion of intervention.

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

30

years-old

<=

Age-upper limit

70

years-old

>

Gender

Male

Key inclusion criteria

Having a period when the outpatient examination for the purpose of treating diabetes at the intervals required by medical institutions after diagnosis of type 2 diabetes is not performed for more than 6 months on the basis of some sort of circumstances or judgment.
Whether or not there is current work, the period during which no consultation was done does not matter.
The examination status at the time of recruitment does not matter.

Key exclusion criteria

Weight loss is over 10kg in 3 months.
Difficult to communicate in Japanese, read and write in Japanese.
Difficult to walk by walking alone.
Receiving maintenance dialysis therapy.
Undergoing cancer treatment.
There is cloudiness of consciousness.
There is a ketone smell.
Blood glucose of over 500mg.
Have a serious foot ulcer.
Fever is seen.
There is painful inflammation.

Target sample size

16

Name of lead principal investigator

1st name	Akiko
Middle name
Last name	Yoneda

Organization

Yamanashi Prefectural University

Division name

Nursing

Zip code

4000062

Address

1-6-1 Ikeda Kofu city Yamanashi prefecture

TEL

+81-055-253-9445

Email

yonedaok@yamanashi-ken.ac.jp

Name of contact person

1st name	Akiko
Middle name
Last name	Yoneda

Organization

Yamanashi Prefectural University

Division name

Nursing

Zip code

4000062

Address

1-6-1 Ikeda Kofu city Yamanashi prefecture

TEL

+81-055-253-9445

Homepage URL

Email

yonedaok@yamanashi-ken.ac.jp

Institute

St.Luke's International University

Institute

Department

Personal name

Organization

Yamanashi Prefectural University

Organization

Division

Category of Funding Organization

Local Government

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Yamanashi Prefectural Univercity Faculty of Nursing

Address

1-6-1 Ikeda Kofu city Yamanashi prefecuture

Tel

0552539445

Email

yonedaok@yamanashi-ken.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2019

Year

03

Month

22

Day

URL releasing protocol

This study protocol is not available to the public.

Publication of results

Unpublished

URL related to results and publications

This study protocol is not available to the public.

Number of participants that the trial has enrolled

12

Results

Ten individuals who completed the care program (completion rate 83.3%) were tested. There was no significant difference in <ability to self-manage according to oneself> before program intervention (T0) and after care 7 (T3) (P = .310). (T0) and after Care 3 (T1), <Ability to self-manage in a self-respecting manner> (P = .011); = 0.028), and a significant difference was observed in <ability to manage oneself in a way that is oneself> (P = .017).
17)

Results date posted

2022

Year

08

Month

24

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

The median age for each attribute was 49years, 10 years of diabetes history, and 5 years of discontinuation of diabetes treatment. 8 (66.7%) of the subjects remembered 　the blood glucose level at the time of 　　diagnosis, and 7(58.3%) remembered the
HbA1c. The most recent glycemic control status was a median blood glucose level of　 170 mg/dl and HbA1c of 9.0%. As for 　　　　physique, median weight was 77.0 kg, BMI 　was 26.0, body fat was 27.0%, and waist 　circumference was 92.0 cm. 7 patients (58.3%) had a BMI of 25 or more, an indicator of obesity, and 8 patients (66.7%) had a waist circumference of 85 cm or more.
At the time of recruitment, all patients had resumed outpatient visits for diabetes treatment, and all patients received drug therapy, including insulin therapy in 3 patients (25%). As a symptom of hyperglycemia, 4 patients (33.3%) had increased thirst, and 2 had increased urination frequency.
All of them had jobs, and there
occupations were diverse, such as sales,
civil servants, and construction workers.

Participant flow

13 people were recruited in 4 fields where permission for research cooperation was 　　obtained, and consent was obtained from 12 people. There were 12 patients from before intervention (T0) to after care 3 (T1), 10 after care 6 (T2) (withdrawal rate 16.73%), and 10 after care 7 (T3).

Adverse events

There were no adverse events.

Outcome measures

The IDSCA (instrument of diabetes self-care agency) created by Shimizu et al. (2011) was used.
In particular, a significant increase in the score after the completion of Care 7 (T3) compared to before the intervention (T0) in [the ability to self-manage] was set as the primary outcome as an effect of this care program.

Mental and physical well-being: Measured by SF-8 (Standard Comprehensive Health-Related Quality of Life Scale) (Appendix 2).

Symptoms of chronic complications: Catch symptoms with a self-made questionnaire "Symptoms of Chronic Complications" consisting of foot symptoms, questions about how you see things, visual acuity tests, and blood pressure and pulse measurements.

The absence of exacerbation of hyperglycemia symptoms was determined by self-made questionnaire "Hyperglycemia symptoms" consisting of questions on thirst, oral sensation, frequency of urination, dry skin, weight, body fat, waist circumference, and occasional blood sugar level. I caught it with

Behavior when receiving medical care when needed was captured using a self-made questionnaire, ``Behavior when receiving medical care when needed,'' which consisted of questions about the situation at the time of consultation, the reason, the clinical department, and how to communicate to the doctor.

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2019

Year

03

Month

21

Day

Date of IRB

2019

Year

07

Month

06

Day

Anticipated trial start date

2019

Year

03

Month

21

Day

Last follow-up date

2021

Year

04

Month

30

Day

Date of closure to data entry

2021

Year

05

Month

31

Day

Date trial data considered complete

2021

Year

05

Month

31

Day

Date analysis concluded

2021

Year

06

Month

30

Day

Other related information

Registered date

2019

Year

02

Month

20

Day

Last modified on

2024

Year

02

Month

25

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040954