Type 2 Diabetes
Conditions
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
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
Study design
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| HbA1C | 12 weeks | Improvement in glycemic control |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Score of Diabetes Care Profile-Attitudes Toward Diabetes Scales | 12 weeks | 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 of Summary of Diabetes Self-Care Activities | 12 weeks | 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 of Simplified True / False Version of Diabetes Knowledge Scale | 12 weeks | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Score of Newest Vital Sign | 12 weeks | 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. |
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
| Arm | Count |
|---|---|
| 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 |
| Total | 181 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 9 | 12 |
Baseline characteristics
| Characteristic | Intervention Group | Control Group | Total |
|---|---|---|---|
| Age, Continuous | 59.0 years STANDARD_DEVIATION 11.4 | 58.1 years STANDARD_DEVIATION 11.9 | 58.6 years STANDARD_DEVIATION 11.6 |
| Alcohol Drinking | 36 Participants | 29 Participants | 65 Participants |
| Annual Income (in New Taiwan dollar) >1,000,000 | 18 Participants | 14 Participants | 32 Participants |
| Annual Income (in New Taiwan dollar) <500,000 | 18 Participants | 25 Participants | 43 Participants |
| Annual Income (in New Taiwan dollar) 500,000-1,000,000 | 27 Participants | 21 Participants | 48 Participants |
| Annual Income (in New Taiwan dollar) Unwaged | 28 Participants | 30 Participants | 58 Participants |
| Body Mass Index | 26.1 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 Time | 10.4 years STANDARD_DEVIATION 9 | 10.3 years STANDARD_DEVIATION 8.1 | 10.3 years STANDARD_DEVIATION 8.5 |
| Education Level College or higher | 51 Participants | 53 Participants | 104 Participants |
| Education Level Junior high school or below | 14 Participants | 13 Participants | 27 Participants |
| Education Level Senior high school | 26 Participants | 24 Participants | 50 Participants |
| HbA1C | 7.0 % STANDARD_DEVIATION 0.8 | 6.7 % STANDARD_DEVIATION 0.6 | 6.8 % STANDARD_DEVIATION 0.7 |
| Living alone | 3 Participants | 3 Participants | 6 Participants |
| Medication Type Both | 15 Participants | 17 Participants | 32 Participants |
| Medication Type Insulin only | 8 Participants | 1 Participants | 9 Participants |
| Medication Type Oral medication only | 68 Participants | 72 Participants | 140 Participants |
| Physical Exercise | 70 Participants | 63 Participants | 133 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 91 Participants | 90 Participants | 181 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Self Monitoring Blood Glucose | 37 Participants | 42 Participants | 79 Participants |
| Sex: Female, Male Female | 24 Participants | 33 Participants | 57 Participants |
| Sex: Female, Male Male | 67 Participants | 57 Participants | 124 Participants |
| Smoking | 10 Participants | 15 Participants | 25 Participants |
| Unemployment | 36 Participants | 40 Participants | 76 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
HbA1C
Improvement in glycemic control
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group | HbA1C | 7.0 % of HbA1C | Standard Deviation 0.9 |
| Control Group | HbA1C | 6.7 % of HbA1C | Standard Deviation 0.7 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group | Score of Diabetes Care Profile-Attitudes Toward Diabetes Scales | 3.8 score on a scale | Standard Deviation 0.5 |
| Control Group | Score of Diabetes Care Profile-Attitudes Toward Diabetes Scales | 3.7 score on a scale | Standard Deviation 0.5 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group | Score of Simplified True / False Version of Diabetes Knowledge Scale | 76.7 correctness | Standard Error 11.7 |
| Control Group | Score of Simplified True / False Version of Diabetes Knowledge Scale | 73.2 correctness | Standard Error 12.6 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group | Score of Summary of Diabetes Self-Care Activities | 4.0 score on a scale | Standard Deviation 1.2 |
| Control Group | Score of Summary of Diabetes Self-Care Activities | 3.9 score on a scale | Standard Deviation 1.5 |
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