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临床试验/NCT07195188
NCT07195188已完成不适用

The Effect of Game-based Education on Adherence to Treatment and Anxiety Level in Type 2 Diabetics Started on Insulin Therapy

Izmir Tinaztepe University1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2024年4月5日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
72
试验地点
1
主要终点
Treatment Compliance Levels

研究概览

简要总结

The goal of this clinical trial is to learn if an education program can help lower anxiety and improve treatment follow-up in adults with type 2 diabetes. The main questions it aims to answer are:

Does attending the education program lower anxiety levels?

Does it help people better follow their diabetes treatment plan?

Researchers will compare two groups:

Education group: Participants who attend the program.

Control group: Participants who do not attend the program.

Participants will:

Be randomly assigned to either the education group or the control group.

Attend four weekly sessions, each lasting two hours, over one month (education group only).

Complete surveys before and after the program, including the Beck Anxiety Scale (to measure anxiety) and the Patient Compliance Scale for Type 2 Diabetes Mellitus Treatment (to measure treatment follow-up).

详细描述

Study Type: This is a clinical trial that tests a diabetes education program. Number of Participants: A total of 72 people participated in the study

Group Assignment: Participants were randomly assigned to one of two groups:

Game-Based Education Group Traditional Education Group Study Model: Both groups were given diabetes education simultaneously, but through different methods Blinding: This was an open-label study in which both the researchers and the participants were aware of the type of education they received

Main Goal: To test whether a game-based education program can:

Improve how well people follow their diabetes treatment plan Lower anxiety levels in people recently starting insulin therapy Groups and Interventions

研究设计

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

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •nclusion Criteria:
  • •Age at diagnosis of diabetes is at least 1 year.
  • •The maximum duration of insulin treatment initiation is 3 months.
  • •Not having any mental problems.
  • •Between the ages of 40 and 65 years.
  • •Volunteering to participate in the study.

排除标准

  • •Age at diagnosis of diabetes is recent or less than 1 year.
  • •Being on insulin therapy for more than three months.
  • •Mental or psychological comorbidity.
  • •Not within the target age range, under 40 years or over 65 years.
  • •Refusing to participate in the research.
  • •Not attending one or more of the four training sessions during the research process.

研究组 & 干预措施

Game-Based Education

Experimental

Arm Description:

Participants in this group will receive diabetes education using the "Let's Learn Diabetes" board game. The program consists of four weekly sessions, each lasting two hours, conducted over one month. The sessions aim to improve diabetes knowledge, reduce anxiety, and increase adherence to insulin therapy.

干预措施: "Let's Learn Diabetes" Game-Based Education (Behavioral)

Traditional Diabetes Education

Active Comparator

Participants in the control group will receive standard diabetes education through traditional lecture-based presentations. The education schedule matches the experimental group with four weekly sessions, each lasting two hours, over one month.

干预措施: Traditional Diabetes Education (Behavioral)

结局指标

主要结局

Treatment Compliance Levels

时间窗: Pre-intervention and Post-intervention (After 1 Month of Training)

For Treatment Compliance: The level of compliance among individuals undergoing diabetes-to-diabetes treatment was determined using the Patient Compliance Scale for Type 2 Diabetes Treatment, a 30-item, five-point Likert-type scale. A low total score indicates high patient compliance. For Anxiety: "Anxiety levels of individuals with diabetes were determined using the Beck Anxiety Scale (BAS), a 21-item, four-point Likert-type self-report scale. Higher scores indicate more severe anxiety.

次要结局

未报告次要终点

研究者

发起方
Izmir Tinaztepe University
申办方类型
Other
责任方
Principal Investigator
主要研究者

gönül düzgün

assistant profesor

Izmir Tinaztepe University

研究点 (1)

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