Clinical trial NCT06331338: Effects of Using Decision Cycle for Person-Centered Glycemic Management in Type 2 Diabetes
Official title: Research on the Effectiveness of Using Decision Cycle for Person-Centered Glycemic Management on Self-Care Behaviors in Outpatients With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Type 2 Diabetes
Keywords: Decision Cycle for Person-Centered Glycemic Management
Self-Care Behaviors
Type 2 Diabetes
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2024-03-26
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Decision cycle for person-centered glycemic management is a new diabetes decision making .It is defined as a purposefully designed holistic care intervention .The goal is to improve the self-care behavior of patients with type 2 diabetes, thereby improving glycated hemoglobin levels and delaying the occurrence of complications.

Detailed description: The "Decision Cycle for Person-Centered Glycemic management" jointly proposed by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD) in 2018 , which develops treatment goals and plans based on the patient's personal preferences, values, and goals.

Participants will be divided into two groups(treatment group 、control group).Treatment group will accept the "Decision Cycle for Person-Centered Glycemic Management " .It is a person-centered diabetes decision making. Control group will accept the traditional diabetes self-management education. It content focuses more on teaching relevant knowledge and some skills.It is a educator-centered approach.

Baseline / pre-intervention test (after signing informed consent form) post-intervention test (after finishing intervention) Researchers will compare treatment group and control group to see if treatment group has better performance on self-care Behaviors and glycated hemoglobin levels .

Eligibility criteria: Inclusion Criteria:

1. Patients diagnosed with type 2 diabetes by a physician.
2. Age: 18 years or above.
3. Glycated hemoglobin (HbA1c ) test value: 7.5-9.0 %
4. No diabetic oral medications, insulin and glucagon-like peptide-1 were replaced in the outpatient when the case was admitted.
5. No pregnancy during the study period.
6. After the researcher explains the purpose of the research, the research subjects agree to join this researcher.
7. Those who are conscious and able to take care of themselves.
8. There is no diagnostic certificate from the American Psychiatric Association's Diagnostic Manual of Mental Disorders, Fourth Edition (DSM-IV)of all mental illnesses.
9. Those who can communicate in Mandarin and Taiwanese.

Exclusion Criteria:

1. Patients diagnosed with type 1 diabetes by a physician.
2. Age: Under 18 years old.
3. Glycated hemoglobin test value: less than 7.5 % and greater than 9.0 %
4. Those who replaced oral diabetes medications, insulin and glucagon-like peptide- 1 at the outpatient at the time of admission.
5. Pregnancy during the study period.
6. Those who are unable to take care of themselves and express themselves.

Primary outcomes:
measure: glycemic control (HbA1c)
timeFrame: Before the task and 3 months post intervention
Secondary outcomes:
measure: Diabetes Self-Care Behavior Scale
timeFrame: Before the task and 3 months post intervention
Other outcomes:
Locations:
city: Hsinchu
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University
name: Kang-Chih Fan
role: PRINCIPAL_INVESTIGATOR
References: