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
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:
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.
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 →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.
Exclusion Criteria:
Patients in the intervention group received Taipei Medical University (TMU) line-oriented video education and care in addition to usual care
Behavioral: TMU-LOVE
Patients in the control group received usual care
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.
HbA1C
Improvement in glycemic control
Time frame: 12 weeks
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
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
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
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
| Milestone | Intervention Group | Control Group |
|---|---|---|
| Started | 91 | 90 |
| Completed | 82 | 78 |
| Not completed | 9 | 12 |
| Withdrew: Lost to follow-up | 9 | 12 |
Improvement in glycemic control
| % of HbA1C | Intervention Group | Control Group |
|---|---|---|
| HbA1C | 7.0 ± 0.9 | 6.7 ± 0.7 |
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.
| score on a scale | Intervention Group | Control Group |
|---|---|---|
| Score of Diabetes Care Profile-Attitudes Toward Diabetes Scales | 3.8 ± 0.5 | 3.7 ± 0.5 |
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.
| score on a scale | Intervention Group | Control Group |
|---|---|---|
| Score of Summary of Diabetes Self-Care Activities | 4.0 ± 1.2 | 3.9 ± 1.5 |
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.
| correctness | Intervention Group | Control Group |
|---|---|---|
| Score of Simplified True / False Version of Diabetes Knowledge Scale | 76.7 ± 11.7 | 73.2 ± 12.6 |
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.
Results for this outcome have not been posted.
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Intervention | — | — | — |
| Control | — | — | — |
| Age, Continuous(years) | Intervention Group | Control Group | Total |
|---|---|---|---|
| Mean | 59.0 ± 11.4 | 58.1 ± 11.9 | 58.6 ± 11.6 |
| Sex: Female, Male(Participants) | Intervention Group | Control Group | Total |
|---|---|---|---|
| Female | 24 | 33 | 57 |
| Male | 67 | 57 | 124 |
| Race (NIH/OMB)(Participants) | Intervention Group | Control Group | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 0 | 0 | 0 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 91 | 90 | 181 |
| Education Level(Participants) | Intervention Group | Control Group | Total |
|---|---|---|---|
| Junior high school or below | 14 | 13 | 27 |
| Senior high school | 26 | 24 | 50 |
| College or higher | 51 | 53 | 104 |
| Body Mass Index(kg/m^2) | Intervention Group | Control Group | Total |
|---|---|---|---|
| Mean | 26.1 ± 4.2 | 26.7 ± 5.0 | 26.4 ± 4.6 |
| Unemployment(Participants) | Intervention Group | Control Group | Total |
|---|---|---|---|
| Count of participants | 36 | 40 | 76 |
| Living alone(Participants) | Intervention Group | Control Group | Total |
|---|---|---|---|
| Count of participants | 3 | 3 | 6 |
| Annual Income (in New Taiwan dollar)(Participants) | Intervention Group | Control Group | Total |
|---|---|---|---|
| Unwaged | 28 | 30 | 58 |
| <500,000 | 18 | 25 | 43 |
| 500,000-1,000,000 | 27 | 21 | 48 |
| >1,000,000 | 18 | 14 | 32 |
7 further baseline measures are reported on the registry.
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Taipei Medical University