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CompletedNCT04876274Updated Mar 18, 2022Results posted

Social Media-Delivered Patient Education in Enhancing Type 2 Diabetics Self-Management and Attitudes During the COVID-19 Pandemic

An interventional study of TMU-LOVE in Type 2 Diabetes, sponsored by Taipei Medical University. Completed at 1 site in Taiwan. Open to participants aged 20 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-03-18.

Sponsored by Taipei Medical University · Not applicable, Interventional, and Other

From the registry’s dates

  • Registered 9 months after the study started (first participant enrolled Jul 2020, registered May 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
181
Allocation
Randomized
Ages
20 Years and older
Sex
All
01

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

The study was conducted in the Endocrinology and Metabolism Clinic in Taipei Medical University Wang-Fang Hospital. Patients were referred from physicians if they met the inclusion criteria and consent to join. Written consent and questionnaires were then provided to the participants after researcher had clearly explained the study purpose.

Based on the seven key points in managing diabetes developed by the association of diabetes care and education specialist (ADCES), including healthy coping, healthy eating, being active, monitoring, taking medication, problem solving and reducing risks, the research team had developed 51 diabetes related health educational videos (available at website of School of Pharmacy, Taipei Medical University http://pharmschool.tmu.edu.tw/activity/index.php?type=20). Each video lasted for about 2-3 minutes. According to the content of the videos, it was categorized into 5 domains, including understanding diabetes, daily care, nutrition care, diabetes drug and diabetes knowledge related quizzes.

Patients in intervention group could attend the video through the line platform. Researcher would also send 2-3 videos per week with care massage every 2 weeks to the patients. The general schedule of video was shown in table x. According to various condition, researcher developed specific video schedule for each patients. For example, patient who was prescribed with A drug, we would only send the video regarding A drug to this patient but not all of the video regarding drugs. Schedule for the part of understanding diabetes, daily care, nutrition care and quizzes was the same among all participants. Due to the quizzes that were put in week 3, 6, 9 and 12, videos related to general knowledge about diabetes would be send to patients first to make sure all the quizzes related content had already taught to patients before the quizzes. Moreover, patients could communicate with the research team and ask questions through the platform, researcher would provide answers verified by pharmacists or physicians in one or two days after.

The sample size of this study was estimated using G-power (version 3.1). Assuming a power of 80% with two-sided alpha level for detecting the difference between the intervention group and the control group, at least 64 patients were needed for each group. Considering 20% dropout rate, the study was designed to have at least 80 patients for each group, 160 patients in total.

Patients were randomized in a 1:1 ratio according to the random allocation sequence generated prior to the study. Patients with odd number were allocated into control group while even numbers were allocated into intervention group. The trial was non-blinded because of its feasibility.

Researcher would not provide any inductive explanation to the patient during filling the questionnaire. If patient had questions about the items, a detailed explanation and health education were provided only after finishing the post-test. The returned questionnaires were collected by the researcher and kept in the Department of Clinical Pharmacy, School of Pharmacy, Taipei Medical University for three years.

All the data were analyzed using SPSS (SPSS Inc. Released 2009. Predictive Analytics Suite Workstation (PASW) Statistics for Windows, Version 18.0. Chicago: SPSS Inc.). A two-tailed p value of 0.05 was considered to be statistically significant in the analysis. For personal characteristics, descriptive analysis was performed. According to the characteristic of data, Chi-square test and t-test was used for detecting the differences between groups. a Wilcoxon signed rank test or paired t-tests was performed for the differences in A1C and the scores between pre and post-test about knowledge, self-care activity and attitude towards diabetes. A Mann-Whitney test or unpaired t-tests was performed for the mean differences between control and intervention group. Logistics regression was performed for the correlation between variables.

Patients who had finished both pre- and post-assessment would be included for analysis, those without post-test would be excluded. Missing values were processed by multiple imputation.

02

Conditions studied

  • Type 2 Diabetes

Keywords

  • Type 2 diabetes
  • Self-management
  • Health education
  • Attitudes towards diabetes
  • mHealth
  • Video education
03

In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's enrollment of 181 is above the median of 100 across 4,099 interventional studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

Taipei Medical University is the lead sponsor of 245 studies on the registry; 56 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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%

Exclusion criteria

Exclusion Criteria:

  • Gestational diabetes
  • Cognitive impairment
  • No medication treatment but dietary control alone
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
181 participants (actual)

Study arms

  • Experimental
    Intervention group

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

    Behavioral: TMU-LOVE

  • No intervention
    Control group

    Patients in the control group received usual care

Interventions

  • BehavioralTMU-LOVE

    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.

06

What researchers measure

Primary outcomes

  1. HbA1C

    Improvement in glycemic control

    Time frame: 12 weeks

Secondary outcomes

  1. Score of Diabetes Care Profile-Attitudes Toward Diabetes Scales

    The Chinese version of Diabetes Care Profile-Attitudes Toward Diabetes Scales (DCP-ATDS) was used for measuring patients' attitude towards diabetes at baseline and 12 weeks. Each item was rated on a five-point Likert scale, the total score was in the range of 23-115, in which higher scores mean patient had better attitudes towards diabetes.

    Time frame: 12 weeks

  2. Score of Summary of Diabetes Self-Care Activities

    The Chinese version of Summary of Diabetes Self-Care Activities (SDSCA) was used for measuring patients' self-care activities at baseline and 12 weeks. Each item was rated from 0 to 7. For patients who were prescribed with either oral medication or insulin injection, the total score ranged from 0 to 63. The total score for patients who were taking both oral and insulin medications ranged from 0 to 70. The mean scores were calculated separately according to the total score ranges. A higher scores mean better self-care behavior.

    Time frame: 12 weeks

  3. Score of Simplified True / False Version of Diabetes Knowledge Scale

    The Chinese version of Simplified true/false version of revised Diabetes Knowledge Scale (SDKS) was used for measuring patients' knowledge about diabetes at baseline and 12 weeks. A score of "1" was given if the patient responded with the correct answer and "0" was given for incorrect answer or answered with "Don't know". For patients who were prescribed with insulin treatment, the total score ranged from 0 to 24, for those without insulin treatment, the total score ranged from 0 to 22. The mean scores were calculated separately according to the total score ranges. A higher score indicated higher level of knowledge about diabetes.

    Time frame: 12 weeks

Other outcomes

  1. Score of Newest Vital Sign

    The Chinese version of Newest Vital Sign (NVS) was used for measuring patients' health literacy level. A score of "1" was given if the patient responded with the correct answer and "0" was given for incorrect answer. The total score ranged from 0 to 6, with higher scores mean better health literacy level.

    Time frame: 12 weeks

07

Results

Posted Dec 13, 2021
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.

Participant flow

Participant flow — Overall Study
MilestoneIntervention GroupControl Group
Started9190
Completed8278
Not completed912
Withdrew: Lost to follow-up912

Outcome measures

PrimaryHbA1C

Improvement in glycemic control

Time frame:
12 weeks
Reported as:
Mean · % of HbA1C
HbA1C
% of HbA1CIntervention GroupControl Group
HbA1C7.0 ± 0.96.7 ± 0.7
SecondaryScore of Diabetes Care Profile-Attitudes Toward Diabetes Scales

The Chinese version of Diabetes Care Profile-Attitudes Toward Diabetes Scales (DCP-ATDS) was used for measuring patients' attitude towards diabetes at baseline and 12 weeks. Each item was rated on a five-point Likert scale, the total score was in the range of 23-115, in which higher scores mean patient had better attitudes towards diabetes.

Time frame:
12 weeks
Reported as:
Mean · score on a scale
Score of Diabetes Care Profile-Attitudes Toward Diabetes Scales
score on a scaleIntervention GroupControl Group
Score of Diabetes Care Profile-Attitudes Toward Diabetes Scales3.8 ± 0.53.7 ± 0.5
SecondaryScore of Summary of Diabetes Self-Care Activities

The Chinese version of Summary of Diabetes Self-Care Activities (SDSCA) was used for measuring patients' self-care activities at baseline and 12 weeks. Each item was rated from 0 to 7. For patients who were prescribed with either oral medication or insulin injection, the total score ranged from 0 to 63. The total score for patients who were taking both oral and insulin medications ranged from 0 to 70. The mean scores were calculated separately according to the total score ranges. A higher scores mean better self-care behavior.

Time frame:
12 weeks
Reported as:
Mean · score on a scale
Score of Summary of Diabetes Self-Care Activities
score on a scaleIntervention GroupControl Group
Score of Summary of Diabetes Self-Care Activities4.0 ± 1.23.9 ± 1.5
SecondaryScore of Simplified True / False Version of Diabetes Knowledge Scale

The Chinese version of Simplified true/false version of revised Diabetes Knowledge Scale (SDKS) was used for measuring patients' knowledge about diabetes at baseline and 12 weeks. A score of "1" was given if the patient responded with the correct answer and "0" was given for incorrect answer or answered with "Don't know". For patients who were prescribed with insulin treatment, the total score ranged from 0 to 24, for those without insulin treatment, the total score ranged from 0 to 22. The mean scores were calculated separately according to the total score ranges. A higher score indicated higher level of knowledge about diabetes.

Time frame:
12 weeks
Reported as:
Mean · correctness
Score of Simplified True / False Version of Diabetes Knowledge Scale
correctnessIntervention GroupControl Group
Score of Simplified True / False Version of Diabetes Knowledge Scale76.7 ± 11.773.2 ± 12.6
Other pre-specifiedScore of Newest Vital Sign

The Chinese version of Newest Vital Sign (NVS) was used for measuring patients' health literacy level. A score of "1" was given if the patient responded with the correct answer and "0" was given for incorrect answer. The total score ranged from 0 to 6, with higher scores mean better health literacy level.

Time frame:
12 weeks

Results for this outcome have not been posted.

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Intervention———
Control———

Baseline characteristics

Age, Continuous
Age, Continuous(years)Intervention GroupControl GroupTotal
Mean59.0 ± 11.458.1 ± 11.958.6 ± 11.6
Sex: Female, Male
Sex: Female, Male(Participants)Intervention GroupControl GroupTotal
Female243357
Male6757124
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Intervention GroupControl GroupTotal
American Indian or Alaska Native000
Asian000
Native Hawaiian or Other Pacific Islander000
Black or African American000
White000
More than one race000
Unknown or Not Reported9190181
Education Level
Education Level(Participants)Intervention GroupControl GroupTotal
Junior high school or below141327
Senior high school262450
College or higher5153104
Body Mass Index
Body Mass Index(kg/m^2)Intervention GroupControl GroupTotal
Mean26.1 ± 4.226.7 ± 5.026.4 ± 4.6
Unemployment
Unemployment(Participants)Intervention GroupControl GroupTotal
Count of participants364076
Living alone
Living alone(Participants)Intervention GroupControl GroupTotal
Count of participants336
Annual Income (in New Taiwan dollar)
Annual Income (in New Taiwan dollar)(Participants)Intervention GroupControl GroupTotal
Unwaged283058
<500,000182543
500,000-1,000,000272148
>1,000,000181432

7 further baseline measures are reported on the registry.

08

Study locations

1 site
  • School of Pharmacy, Taipei Medical University
    Taipei, Taiwan
09

References and documents

Publications

  • 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. PubMed 35319478 ↗

Study documents

  • Protocol and statistical analysis plan · Feb 10, 2022

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 18, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04876274
Lead sponsor
Taipei Medical University
Collaborators
Taipei Medical University WanFang Hospital
Responsible party
LEONG CHENG MAN (Master student, School of Pharmacy, Taipei Medical University, Taipei Medical University) — Principal investigator
First posted
May 6, 2021
Start date
Jul 14, 2020
Primary completion
Dec 29, 2020
Completion
Dec 29, 2020
Results posted
Dec 13, 2021
Last update
Mar 18, 2022

Study contacts

Chen Hsiang-Yin, Pharm.D.
study director · Professor and Associate Dean, College of Pharmacy, Taipei Medical University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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