NCT07810647

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started May 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 12, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2020

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

March 14, 2022

Completed
4.5 years until next milestone

First Posted

Study publicly available on registry

September 9, 2026

Completed
Last Updated

September 9, 2026

Status Verified

September 1, 2021

Enrollment Period

6 months

First QC Date

March 14, 2022

Last Update Submit

September 4, 2026

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (10)

  • Diabetes self-efficacy scale

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

    Pre-test (baseline)

  • Diabetes self-efficacy scale

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

    1 months after intervnetion

  • Diabetes self-efficacy scale

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

    3 months after intervnetion

  • Diabetes health literacy scale

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

    Pre-test (baseline)

  • Diabetes health literacy scale

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

    3 months after intervnetion

  • Diabetes health promotion scale

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

    Pre-test (baseline)

  • Diabetes health promotion scale

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

    1 months after intervnetion

  • Diabetes health promotion scale

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

    3 months after intervnetion

  • Hemoglobin A1C (HbA1c) Test

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

    3 months after intervnetion

  • Hemoglobin A1C (HbA1c) Test

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

    Pre-test (baseline)

Study Arms (2)

Control group:as usual care

NO INTERVENTION

The control group received as usual care.

Experimental group:The intervention of SDM

EXPERIMENTAL

The experimental group received the intervention of SDM 3 times for 3 months,

Behavioral: SDM

Interventions

SDMBEHAVIORAL

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

Experimental group:The intervention of SDM

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

An Nan Hospition-China Medical University

Tainan, Taiwan, 709204, Taiwan

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

SDM

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 14, 2022

First Posted

September 9, 2026

Study Start

May 12, 2020

Primary Completion

October 30, 2020

Study Completion

June 30, 2021

Last Updated

September 9, 2026

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)