Skip to content

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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04876274
Enrollment
181
Registered
2021-05-06
Start date
2020-07-14
Completion date
2020-12-29
Last updated
2022-03-18

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

Conditions

Type 2 Diabetes

Keywords

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

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. 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.

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.

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.

Sponsors

Taipei Medical University WanFang Hospital
CollaboratorOTHER
Taipei Medical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
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

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

Design outcomes

Primary

MeasureTime frameDescription
HbA1C12 weeksImprovement in glycemic control

Secondary

MeasureTime frameDescription
Score of Diabetes Care Profile-Attitudes Toward Diabetes Scales12 weeksThe 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.
Score of Summary of Diabetes Self-Care Activities12 weeksThe 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.
Score of Simplified True / False Version of Diabetes Knowledge Scale12 weeksThe 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.

Other

MeasureTime frameDescription
Score of Newest Vital Sign12 weeksThe 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.

Countries

Taiwan

Participant flow

Pre-assignment details

Before assignment, patients were excluded if they did not meet the inclusion criteria or declined to participate, or did not sign the informed consent.

Participants by arm

ArmCount
Intervention Group
Patients in the intervention group received the TMU line-oriented video education and care in addition to usual care TMU-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.
91
Control Group
Patients in the control group received usual care
90
Total181

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyLost to Follow-up912

Baseline characteristics

CharacteristicIntervention GroupControl GroupTotal
Age, Continuous59.0 years
STANDARD_DEVIATION 11.4
58.1 years
STANDARD_DEVIATION 11.9
58.6 years
STANDARD_DEVIATION 11.6
Alcohol Drinking36 Participants29 Participants65 Participants
Annual Income (in New Taiwan dollar)
>1,000,000
18 Participants14 Participants32 Participants
Annual Income (in New Taiwan dollar)
<500,000
18 Participants25 Participants43 Participants
Annual Income (in New Taiwan dollar)
500,000-1,000,000
27 Participants21 Participants48 Participants
Annual Income (in New Taiwan dollar)
Unwaged
28 Participants30 Participants58 Participants
Body Mass Index26.1 kg/m^2
STANDARD_DEVIATION 4.2
26.7 kg/m^2
STANDARD_DEVIATION 5
26.4 kg/m^2
STANDARD_DEVIATION 4.6
Diagnosis Time10.4 years
STANDARD_DEVIATION 9
10.3 years
STANDARD_DEVIATION 8.1
10.3 years
STANDARD_DEVIATION 8.5
Education Level
College or higher
51 Participants53 Participants104 Participants
Education Level
Junior high school or below
14 Participants13 Participants27 Participants
Education Level
Senior high school
26 Participants24 Participants50 Participants
HbA1C7.0 %
STANDARD_DEVIATION 0.8
6.7 %
STANDARD_DEVIATION 0.6
6.8 %
STANDARD_DEVIATION 0.7
Living alone3 Participants3 Participants6 Participants
Medication Type
Both
15 Participants17 Participants32 Participants
Medication Type
Insulin only
8 Participants1 Participants9 Participants
Medication Type
Oral medication only
68 Participants72 Participants140 Participants
Physical Exercise70 Participants63 Participants133 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
0 Participants0 Participants0 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
91 Participants90 Participants181 Participants
Race (NIH/OMB)
White
0 Participants0 Participants0 Participants
Self Monitoring Blood Glucose37 Participants42 Participants79 Participants
Sex: Female, Male
Female
24 Participants33 Participants57 Participants
Sex: Female, Male
Male
67 Participants57 Participants124 Participants
Smoking10 Participants15 Participants25 Participants
Unemployment36 Participants40 Participants76 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 00 / 0
other
Total, other adverse events
0 / 00 / 0
serious
Total, serious adverse events
0 / 00 / 0

Outcome results

Primary

HbA1C

Improvement in glycemic control

Time frame: 12 weeks

ArmMeasureValue (MEAN)Dispersion
Intervention GroupHbA1C7.0 % of HbA1CStandard Deviation 0.9
Control GroupHbA1C6.7 % of HbA1CStandard Deviation 0.7
Secondary

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

ArmMeasureValue (MEAN)Dispersion
Intervention GroupScore of Diabetes Care Profile-Attitudes Toward Diabetes Scales3.8 score on a scaleStandard Deviation 0.5
Control GroupScore of Diabetes Care Profile-Attitudes Toward Diabetes Scales3.7 score on a scaleStandard Deviation 0.5
Secondary

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

ArmMeasureValue (MEAN)Dispersion
Intervention GroupScore of Simplified True / False Version of Diabetes Knowledge Scale76.7 correctnessStandard Error 11.7
Control GroupScore of Simplified True / False Version of Diabetes Knowledge Scale73.2 correctnessStandard Error 12.6
Secondary

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

ArmMeasureValue (MEAN)Dispersion
Intervention GroupScore of Summary of Diabetes Self-Care Activities4.0 score on a scaleStandard Deviation 1.2
Control GroupScore of Summary of Diabetes Self-Care Activities3.9 score on a scaleStandard Deviation 1.5
Other Pre-specified

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

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026