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Japanese

Nov. 27, 2021

Sept. 30, 2023

jRCT1060210053

Examination of the usefulness of a health guidance purogram for diabetic patients with obesity:Pirot study

SACCT-DM

Sept. 30, 2023

10

Subjects are type 2 diabetes patients aged 20 or over with HbA1c: 6.5% or more and less than 10%, and BMI: 25 or more and less than 35. The subjects were 7 males and 3 females, with an average age of 59.4 years, an average disease history of 19.5 years, and an average BMI of 28.8.

This study was proceeded without any problems.

Nothing to mention

Of the 10 patients who underwent the program, the primary endpoint, Patient Satisfaction Factor 1 (higher scores indicate higher satisfaction), increased in 6 patients and decreased in 4 patients. On the stress scale, which is a secondary endpoint (higher scores indicate a stronger tendency to avoid experiences and are said to interfere with desired behavior), the score increased in 5 patients, decreased in 4 patients, and remained unchanged in 1 patient.

The hypothesis that both patient satisfaction factor 1 and stress scale improved after intervention did not hold. On the other hand, an average of 80% of action goals were put into practice, which was useful in this respect. In addition, both patients and supporters commented that it was useful for self-management, increased communication, and built a relationship of trust. This suggested the usefulness of the non-numerical part.

No

https://jrct.mhlw.go.jp/latest-detail/jRCT1060210053

Shikata Kenichi

Okayama University Hospital

2-5-1 Shikata-cho,Kita-ku,okayama,Japan

+81-86-235-6508

shikata@md.okayama-u.ac.jp

Takatori Sachiko

Okayama University Hospital

2-5-1 Shikata-cho,Kita-ku,okayama,Japan

+81-86-235-7209

takato-s@okayama-u.ac.jp

Complete

Nov. 27, 2021

Jan. 05, 2022
12

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

health services research

The patient meets all three criteria.
1) Patients with diabetes over 20 years old, HbA1c 6.5% or more, less than 10%, BMI 25 or more, less than 35
2) Patients who have been briefed, understood, and given written consent to participate in the study
3) Outpatient

Patients who fall under any of the four are excluded.
1) Patients who are restricted from exercising by a doctor or who have neuropathy that interferes with exercising
2) Patients with a history of myocardial infarction or cerebral infarction
3) Patients with a history of hospital visits or treatment for psychiatric disorders such as depression and schizophrenia
4) In addition, patients who are judged to be inappropriate as research subjects by the principal investigator or the research coordinator

20age old over
No limit

Both

Type 2 diabetes

Patients self learn using the Health Guidance Program(SACCT Diabetes). Medical staff guide and encourage patients in multiple occupations on the occasion of consultation. In addition, when the patient sees a doctor,
the medical staff gives guidance on Acceptant Commit Therapy(ACT).

Type 2 diabetes

Before and after the program, a questionnaire to measure patient satisfaction will be conducted and scored for evaluation. The patient satisfaction survey uses the Diabetes Treatment Satisfaction Questionnaire (DTSQ) verified by Ishii et al.

(1) Conduct a questionnaire to measure stress coping ability (psychological flexibility) before and after the program, and evaluate it by scoring it. To evaluate stress coping ability (psychological flexibility), we use a scale (Japanese version of Acceptance and Action Questionnaire-II (7 item version)) that measures avoidance of experiences verified by Shima et al.
(2) Measure the weight of at each visit and the abdominal circumference at the start and end of the program. These are indexes for evaluating the therapeutic effect in clinical practice.
(3) As a blood biochemical test, check HbA1c, triglyceride, HDL cholesterol, LDL cholesterol, and total cholesterol. These utilize test data performed in clinical practice.

Kenichi Shikata
Okayama University Clinical Research Committee
2-5-1 Shikata-cho,Kita-ku,Okayama,Japan, Okayama

+81-86-235-7133

ouh-crrb@adm.okayama-u.ac.jp
Approval

Oct. 26, 2021

none

History of Changes

No Publication date
4 Sept. 30, 2023 (this page) Changes
3 June. 17, 2022 Detail Changes
2 Jan. 22, 2022 Detail Changes
1 Nov. 27, 2021 Detail