Trial Outcomes & Findings for Social Media-Delivered Patient Education in Enhancing Type 2 Diabetics Self-Management and Attitudes During the COVID-19 Pandemic (NCT NCT04876274)
NCT ID: NCT04876274
Last Updated: 2022-03-18
Results Overview
Improvement in glycemic control
COMPLETED
NA
181 participants
12 weeks
2022-03-18
Participant Flow
Before assignment, patients were excluded if they did not meet the inclusion criteria or declined to participate, or did not sign the informed consent.
Participant milestones
| Measure |
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.
|
Control Group
Patients in the control group received usual care
|
|---|---|---|
|
Overall Study
STARTED
|
91
|
90
|
|
Overall Study
COMPLETED
|
82
|
78
|
|
Overall Study
NOT COMPLETED
|
9
|
12
|
Reasons for withdrawal
| Measure |
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.
|
Control Group
Patients in the control group received usual care
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
9
|
12
|
Baseline Characteristics
Social Media-Delivered Patient Education in Enhancing Type 2 Diabetics Self-Management and Attitudes During the COVID-19 Pandemic
Baseline characteristics by cohort
| Measure |
Intervention Group
n=91 Participants
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.
|
Control Group
n=90 Participants
Patients in the control group received usual care
|
Total
n=181 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59.0 years
STANDARD_DEVIATION 11.4 • n=5 Participants
|
58.1 years
STANDARD_DEVIATION 11.9 • n=7 Participants
|
58.6 years
STANDARD_DEVIATION 11.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
67 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
124 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
91 Participants
n=5 Participants
|
90 Participants
n=7 Participants
|
181 Participants
n=5 Participants
|
|
Education Level
Junior high school or below
|
14 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Education Level
Senior high school
|
26 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Education Level
College or higher
|
51 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
104 Participants
n=5 Participants
|
|
Body Mass Index
|
26.1 kg/m^2
STANDARD_DEVIATION 4.2 • n=5 Participants
|
26.7 kg/m^2
STANDARD_DEVIATION 5.0 • n=7 Participants
|
26.4 kg/m^2
STANDARD_DEVIATION 4.6 • n=5 Participants
|
|
Unemployment
|
36 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
76 Participants
n=5 Participants
|
|
Living alone
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Annual Income (in New Taiwan dollar)
Unwaged
|
28 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
|
Annual Income (in New Taiwan dollar)
<500,000
|
18 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Annual Income (in New Taiwan dollar)
500,000-1,000,000
|
27 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Annual Income (in New Taiwan dollar)
>1,000,000
|
18 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Medication Type
Oral medication only
|
68 Participants
n=5 Participants
|
72 Participants
n=7 Participants
|
140 Participants
n=5 Participants
|
|
Medication Type
Insulin only
|
8 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Medication Type
Both
|
15 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Diagnosis Time
|
10.4 years
STANDARD_DEVIATION 9.0 • n=5 Participants
|
10.3 years
STANDARD_DEVIATION 8.1 • n=7 Participants
|
10.3 years
STANDARD_DEVIATION 8.5 • n=5 Participants
|
|
HbA1C
|
7.0 %
STANDARD_DEVIATION 0.8 • n=5 Participants
|
6.7 %
STANDARD_DEVIATION 0.6 • n=7 Participants
|
6.8 %
STANDARD_DEVIATION 0.7 • n=5 Participants
|
|
Smoking
|
10 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Alcohol Drinking
|
36 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
|
Self Monitoring Blood Glucose
|
37 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
79 Participants
n=5 Participants
|
|
Physical Exercise
|
70 Participants
n=5 Participants
|
63 Participants
n=7 Participants
|
133 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeksImprovement in glycemic control
Outcome measures
| Measure |
Intervention Group
n=91 Participants
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.
|
Control Group
n=90 Participants
Patients in the control group received usual care
|
|---|---|---|
|
HbA1C
|
7.0 % of HbA1C
Standard Deviation 0.9
|
6.7 % of HbA1C
Standard Deviation 0.7
|
SECONDARY outcome
Timeframe: 12 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.
Outcome measures
| Measure |
Intervention Group
n=91 Participants
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.
|
Control Group
n=90 Participants
Patients in the control group received usual care
|
|---|---|---|
|
Score of Diabetes Care Profile-Attitudes Toward Diabetes Scales
|
3.8 score on a scale
Standard Deviation 0.5
|
3.7 score on a scale
Standard Deviation 0.5
|
SECONDARY outcome
Timeframe: 12 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.
Outcome measures
| Measure |
Intervention Group
n=91 Participants
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.
|
Control Group
n=90 Participants
Patients in the control group received usual care
|
|---|---|---|
|
Score of Summary of Diabetes Self-Care Activities
|
4.0 score on a scale
Standard Deviation 1.2
|
3.9 score on a scale
Standard Deviation 1.5
|
SECONDARY outcome
Timeframe: 12 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.
Outcome measures
| Measure |
Intervention Group
n=91 Participants
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.
|
Control Group
n=90 Participants
Patients in the control group received usual care
|
|---|---|---|
|
Score of Simplified True / False Version of Diabetes Knowledge Scale
|
76.7 correctness
Standard Error 11.7
|
73.2 correctness
Standard Error 12.6
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 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.
Outcome measures
Outcome data not reported
Adverse Events
Intervention
Control
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Professor Hsiang-Yin Chen
School of Pharmacy, Taipei Medical University
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place