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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07810647
Acronym
SDM
Enrollment
70
Registered
2026-09-09
Start date
2020-05-12
Completion date
2021-06-30
Last updated
2026-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 2

Brief 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.

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.

Interventions

BEHAVIORALSDM

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

Sponsors

Fooyin University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Diabetes self-efficacy scalePre-test (baseline)assesses the confidence of diabetes patients in their ability to manage their diet, blood sugar, and physical exercise
Diabetes health literacy scalePre-test (baseline)A disease-specific scale to measure functional, communicative and critical health literacy in primary care
Diabetes health promotion scalePre-test (baseline)A self-report study instrument that includes the health profile, and Diabetes Health Promotion Scale
Hemoglobin A1C (HbA1c) Test3 months after intervnetionAn HbA1c test shows what the average amount of glucose attached to hemoglobin has been over the past three months.

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 10, 2026