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临床试验/NCT04876274
NCT04876274已完成不适用

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

Taipei Medical University1 个研究点 分布在 1 个国家目标入组 181 人开始时间: 2020年7月14日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
181
试验地点
1
主要终点
HbA1C

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Type 2 Diabetes mellitus (T2DM)
  • Age 20 or older
  • Had at least 1 A1C data in the past 6 months
  • Possessed a smart-cellphone

排除标准

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

结局指标

主要结局

HbA1C

时间窗: 12 weeks

Improvement in glycemic control

次要结局

  • Score of Diabetes Care Profile-Attitudes Toward Diabetes Scales(12 weeks)
  • Score of Summary of Diabetes Self-Care Activities(12 weeks)
  • Score of Simplified True / False Version of Diabetes Knowledge Scale(12 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

LEONG CHENG MAN

Master student, School of Pharmacy, Taipei Medical University

Taipei Medical University

研究点 (1)

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