Effectiveness of Shared Decision Making（SDM）on Patients With Poor Control Type 2 Diabetes

NCT07810647 — Not applicable, Completed, 70 participants, Fooyin University

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Registry	NCT07810647, acronym SDM
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: single, prevention
Enrollment	70 (Actual)
Sponsor	Fooyin University (Other)
Conditions	Diabetes Mellitus, Type 2
Interventions	SDM (Behavioral)
Dates	start 2020-05-12, primary completion 2020-10-30, completion 2021-06-30, first posted 2026-09-09, last updated 2026-09-09
Locations	1 site in Taiwan

-Summary

The study is a pilot study, using a convenient sampling method, targeting at outpatient patients with type 2 diabetes who participate in the diabetes co-care program and poor blood sugar control as the research subjects, and randomly assigned. The number of samples is expected to receive 30 patients in each group. The attrition rate estimates about 20%, so there should be 76 people in total, and 38 people in each group. The experimental group was involved in SDM health education; the control group was involved in routine health education. After the implementation of the measures, the self-efficacy and health promotion behavior changes of the two groups and the effectiveness of disease control (glycated hemoglobin, body mass index, waist circumference) were tracked.

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+Detailed description

Background Diabetes and hyperglycemia not only increase the risk of complications of cardiovascular disease and lead to a situation involving exposure to danger of death. Meanwhile, the patient's self-management is one of the key factors affecting the quality control of blood sugar. Thereby, Shared Decision Making (SDM) is a patient-centered medical implementation method that healthcare professionals and patients jointly participate in treatment decision-making to reach a consensus, which can stimulate the health care ability of participants to achieve treatment goals.

Purpose： This research aims to implement the SDM model based on self-efficacy theory through individualized decision-making to strengthen the behavioral motivation of diabetic patients and finally, to improve the patient's health promotion behavior and the effectiveness of blood sugar control.

Method： Study Type: Interventional Actual Enrollment:76 participants Allocation:Randomized Intervention Model:Parallel Assignment Masking:Single(Participant)

Expected results:

It is hoped that the implementation of SDM model will be used to strengthen the behavioral motivation of diabetic patients through individualized decision-making, and to confirm whether it can effectively improve the patient's health behavior and the effectiveness of disease control.

+Arms and interventions

Arm	Type	Interventions	Description
Control group:as usual care	No intervention		The control group received as usual care.
Experimental group:The intervention of SDM	Experimental	Behavioral: SDM	The experimental group received the intervention of SDM 3 times for 3 months,

SDM (Behavioral): The experimental group received the intervention of SDM 3times/month for 3months, then follow the health promotion behavior compliance by phone once a month.

+Outcome measures

Primary outcomes

Diabetes self-efficacy scale [Pre-test (baseline)]: assesses the confidence of diabetes patients in their ability to manage their diet, blood sugar, and physical exercise
Diabetes self-efficacy scale [1 months after intervnetion]: assesses the confidence of diabetes patients in their ability to manage their diet, blood sugar, and physical exercise
Diabetes self-efficacy scale [3 months after intervnetion]: assesses the confidence of diabetes patients in their ability to manage their diet, blood sugar, and physical exercise
Diabetes health literacy scale [Pre-test (baseline)]: A disease-specific scale to measure functional, communicative and critical health literacy in primary care
Diabetes health literacy scale [3 months after intervnetion]: A disease-specific scale to measure functional, communicative and critical health literacy in primary care
Diabetes health promotion scale [Pre-test (baseline)]: A self-report study instrument that includes the health profile, and Diabetes Health Promotion Scale
Diabetes health promotion scale [1 months after intervnetion]: A self-report study instrument that includes the health profile, and Diabetes Health Promotion Scale
Diabetes health promotion scale [3 months after intervnetion]: A self-report study instrument that includes the health profile, and Diabetes Health Promotion Scale
Hemoglobin A1C (HbA1c) Test [3 months after intervnetion]: An HbA1c test shows what the average amount of glucose attached to hemoglobin has been over the past three months.
Hemoglobin A1C (HbA1c) Test [Pre-test (baseline)]: An HbA1c test shows what the average amount of glucose attached to hemoglobin has been over the past three months

+Eligibility

Sex: All, ages: 20 Years to any

Inclusion Criteria:

* Aged>20y/o
* Diagnosed by a physician as type 2 diabetes
* The Diabetes Participated in the Diabetes Shared Care Network
* Glycosylated hemoglobin (A1C)> 7.5%
* Can communicate in Chinese or Taiwanese.

Exclusion Criteria:

* People with mental or cognitive impairment who cannot communicate
* Health Literacy score lower than 6 points

+Locations (1)

Facility	City	Country	Status
An Nan Hospition-China Medical University	Tainan, Taiwan	Taiwan