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Type 2 DiabetesNCT04876274

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

A study testing TMU-LOVE in people with Type 2 Diabetes, run by Taipei Medical University at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 years and olderHealthy volunteers can take part
Conditions the study is for
Type 2 Diabetes
What is being tested?
TMU-LOVE
Could I receive a placebo?
No, everyone receives an active treatment
How many people
181 participants
Where
1 siteTaiwan
Study dates
14 Jul 2020to 29 Dec 2020
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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%

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Taiwan1 site
  • School of Pharmacy, Taipei Medical University

    Taipei

Other trials in Taiwan

About this study

Official title: Social Media-Delivered Patient Education in Enhancing Type 2 Diabetics Self-Management and Attitudes During the COVID-19 Pandemic: a Randomized Controlled Trial in Taiwan

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.

Conditions
Type 2 Diabetes
Being tested
TMU-LOVE
Keywords
Type 2 diabetes, Self-management, Health education, Attitudes towards diabetes, mHealth, Video education
Medical subject headings
Diabetes Mellitus, Type 2, Health Education

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TMU-LOVEBehavioural

    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.

Study groups in NCT04876274
Study groupRoleWhat they receive
Intervention groupExperimentalPatients in the intervention group received Taipei Medical University (TMU) line-oriented video education and care in addition to usual care
Receives: Behavioral: TMU-LOVE
Control groupNo interventionPatients in the control group received usual care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. HbA1C

    Improvement in glycemic control

    Measured: 12 weeks

Secondary outcomes (3)
  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.

    Measured: 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.

    Measured: 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.

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 May 2021
  2. Study start14 Jul 2020
  3. Primary completion29 Dec 2020
  4. Study completion29 Dec 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
181 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04876274
Sponsor's protocol ID
TMU-LOVE
Status last verified
Mar 2022
First submitted
5 May 2021
Last updated
18 Mar 2022
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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

Questions about this trial

What is this clinical trial studying?

A study testing TMU-LOVE in people with Type 2 Diabetes, run by Taipei Medical University at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Dec 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

HbA1C (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04876274, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2022.

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