SACCT-DM

JRCT ID: jRCT1060210053

Registered date:27/11/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Type 2 diabetes
• Date of first enrollment: 05/01/2022
• Target sample size: 12
• Study type: Interventional

Intervention(s)

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).

Outcome(s)

• Primary Outcome: 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.

Secondary Outcome

(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.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

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

Exclude criteria

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

Related Information

• Primary Sponsor: Shikata Kenichi