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Completed

NCT Number: NCT07810647

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

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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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

An Nan Hospition-China Medical University

Tainan, Taiwan, 709204

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Diabetes self-efficacy scale

    Time frame: Pre-test (baseline)

    assesses the confidence of diabetes patients in their ability to manage their diet, blood sugar, and physical exercise

  2. Diabetes self-efficacy scale

    Time frame: 1 months after intervnetion

    assesses the confidence of diabetes patients in their ability to manage their diet, blood sugar, and physical exercise

  3. Diabetes self-efficacy scale

    Time frame: 3 months after intervnetion

    assesses the confidence of diabetes patients in their ability to manage their diet, blood sugar, and physical exercise

  4. Diabetes health literacy scale

    Time frame: Pre-test (baseline)

    A disease-specific scale to measure functional, communicative and critical health literacy in primary care

  5. Diabetes health literacy scale

    Time frame: 3 months after intervnetion

    A disease-specific scale to measure functional, communicative and critical health literacy in primary care

  6. Diabetes health promotion scale

    Time frame: Pre-test (baseline)

    A self-report study instrument that includes the health profile, and Diabetes Health Promotion Scale

  7. Diabetes health promotion scale

    Time frame: 1 months after intervnetion

    A self-report study instrument that includes the health profile, and Diabetes Health Promotion Scale

  8. Diabetes health promotion scale

    Time frame: 3 months after intervnetion

    A self-report study instrument that includes the health profile, and Diabetes Health Promotion Scale

  9. Hemoglobin A1C (HbA1c) Test

    Time frame: 3 months after intervnetion

    An HbA1c test shows what the average amount of glucose attached to hemoglobin has been over the past three months.

  10. Hemoglobin A1C (HbA1c) Test

    Time frame: Pre-test (baseline)

    An HbA1c test shows what the average amount of glucose attached to hemoglobin has been over the past three months

Sponsors and collaborators

Lead sponsor

Fooyin University

Other

Registry information

Acronym: SDM

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
Sep 9, 2026
Registry last updated
Sep 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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