NCT04876274

Brief Summary

The current study was to develop a software "Line@" based health education program, providing video-based health information and communication between diabetes patients and health-care professionals. This study also evaluated its effectiveness on improving glycemic control, attitude towards diabetes, knowledge about diabetes and self-care for type 2 diabetes patients in Taiwan. The followings were the hypotheses of the study:

  1. 1.Compared to the control group, intervention group receiving "Line" based video education has a greater improvement on glycosylated hemoglobin (A1C).
  2. 2.Compared to the control group, intervention group receiving "Line" based video education has a greater positive effect on attitude towards diabetes.
  3. 3.Compared to the control group, intervention group receiving "Line" based video education has a better understanding on diabetic knowledge.
  4. 4.Compared to the control group, intervention group receiving "Line" based video education has a greater positive effect on self-care activity.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
181

participants targeted

Target at P75+ for not_applicable type-2-diabetes

Timeline
Completed

Started Jul 2020

Shorter than P25 for not_applicable type-2-diabetes

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 14, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 29, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 29, 2020

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 5, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 6, 2021

Completed
7 months until next milestone

Results Posted

Study results publicly available

December 13, 2021

Completed
Last Updated

March 18, 2022

Status Verified

March 1, 2022

Enrollment Period

6 months

First QC Date

May 5, 2021

Results QC Date

October 5, 2021

Last Update Submit

March 16, 2022

Conditions

Keywords

Type 2 diabetesSelf-managementHealth educationAttitudes towards diabetesmHealthVideo education

Outcome Measures

Primary Outcomes (1)

  • HbA1C

    Improvement in glycemic control

    12 weeks

Secondary Outcomes (3)

  • Score of Diabetes Care Profile-Attitudes Toward Diabetes Scales

    12 weeks

  • Score of Summary of Diabetes Self-Care Activities

    12 weeks

  • Score of Simplified True / False Version of Diabetes Knowledge Scale

    12 weeks

Other Outcomes (1)

  • Score of Newest Vital Sign

    12 weeks

Study Arms (2)

Intervention group

EXPERIMENTAL

Patients in the intervention group received Taipei Medical University (TMU) line-oriented video education and care in addition to usual care

Behavioral: TMU-LOVE

Control group

NO INTERVENTION

Patients in the control group received usual care

Interventions

TMU-LOVEBEHAVIORAL

Patients in intervention group could attend diabetes-related health educational video through the TMU-LOVE platform. Researcher would also send 2-3 videos per week with care massage every 2 weeks to the patients.

Intervention group

Eligibility Criteria

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

You may qualify if:

  • Type 2 Diabetes mellitus (T2DM)
  • Age 20 or older
  • Had at least 1 A1C data in the past 6 months
  • Possessed a smart-cellphone
  • A1C ≥ 6%

You may not qualify if:

  • Gestational diabetes
  • Cognitive impairment
  • No medication treatment but dietary control alone

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Pharmacy, Taipei Medical University

Taipei, Taiwan

Location

Related Publications (1)

  • Leong CM, Lee TI, Chien YM, Kuo LN, Kuo YF, Chen HY. Social Media-Delivered Patient Education to Enhance Self-management and Attitudes of Patients with Type 2 Diabetes During the COVID-19 Pandemic: Randomized Controlled Trial. J Med Internet Res. 2022 Mar 23;24(3):e31449. doi: 10.2196/31449.

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Health Education

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAdherence InterventionsMedication AdherencePatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Limitations and Caveats

Limitations include the small sample size with a homogenous population in this study, which created population bias and limited the generalizability of the current study. The result in this study could only predict the short-term effect of TMU-LOVE due to a time restriction of 12 weeks, the long-term effect was not feasible.

Results Point of Contact

Title
Professor Hsiang-Yin Chen
Organization
School of Pharmacy, Taipei Medical University

Study Officials

  • Chen Hsiang-Yin, Pharm.D.

    Professor and Associate Dean, College of Pharmacy, Taipei Medical University

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Master student, School of Pharmacy, Taipei Medical University

Study Record Dates

First Submitted

May 5, 2021

First Posted

May 6, 2021

Study Start

July 14, 2020

Primary Completion

December 29, 2020

Study Completion

December 29, 2020

Last Updated

March 18, 2022

Results First Posted

December 13, 2021

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations