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Effectiveness of Web-based Teaching to Traditional Patient Education in the Use of Injectable Fertility Medications

2022年4月19日 更新者:Wake Forest University Health Sciences

The study will be a prospective randomized trial involving human subjects. The study population will consist of all infertility patients presenting to the Carolinas Medical Center Women's Institute who will require injectable use.

Exclusion criteria: Any patient with prior history of IVF injectable use will be excluded from the study.

Independent Variables: The independent variable is the random assignment of each participant to receive either web-based or one on one teaching.

Outcome Variables: The primary outcome variable is the level of knowledge after the intervention. Secondary outcome variables include level of satisfaction with education, preference of educational method, and time required to teach.

Confounding Variables: Potentially confounding variables include age, race, and prior experience with web-based teaching.

研究概览

详细说明

Study Design:

The study will be a prospective randomized trial involving human subjects. The study population will consist of all infertility patients presenting to the Carolinas Medical Center Women's Institute who will require injectable use.

Exclusion criteria: Any patient with prior history of IVF injectable use will be excluded from the study.

Independent Variables: The independent variable is the random assignment of each participant to receive either web-based or one on one teaching.

Outcome Variables: The primary outcome variable is the level of knowledge after the intervention. Secondary outcome variables include level of satisfaction with education, preference of educational method, and time required to teach.

Confounding Variables: Potentially confounding variables include age, race, and prior experience with web-based teaching.

Methods:

  1. A responsible clinician who has acquainted himself/herself with the research protocol will explain the study to each patient. Patients who agree to participate will sign a form documenting informed consent. The patient will then be handed an envelope that determines whether they will receive web-based teaching or one-on-one teaching.
  2. The patients receiving web-based teaching will be taken to a private room to watch a video on injectable medication use. The amount of time required to view the video will be recorded. The video can be paused, rewound and watched as many times as the patient desires.
  3. The patients randomized to one-on-one teaching will be taken to a separate room where they will be taught injectable medication use by one of two training healthcare providers with experience teaching injectable medications. The time spent in the teaching session will be recorded.
  4. After the teaching session, each patient in the study will complete a multiple choice post-test regarding their knowledge of injectable medication use. They will also complete a satisfaction survey which will use a Likert scale to assess the patients' responses. The instructors teaching the one-on-one sessions will not have access to the post-test.

Statistics:

The categorical variables will be summarized with frequencies and percentages while the continuous variables will be evaluated with means and standard deviations. A difference in proportion will be tested based on the data collected between the web-based group and didactic group. Non-inferiority testing will be conducted based on these differences with a 5% significance level. Data analysis will be conducted using SAS statistical software (9.2,Cary,NC,USA) .

Sample Size Estimate:

To predict that the web-based testing group is not inferior to the Didactic testing group about 40 people in each group would be needed to achieve 80% power with a 5% significance level. The sample size needed was calculated using the Z-test. Here it is assumed that the didactic group would get 80% of their answers correct and the web-based group would actually have 90% of their answers correct.

研究类型

介入性

注册 (实际的)

80

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • North Carolina
      • Charlotte、North Carolina、美国、28204
        • Carolinas Medical Center - Women's Institute

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 45年 (成人)

接受健康志愿者

有资格学习的性别

女性

描述

Inclusion Criteria:

  • Patient undergoing ART Therapy and ovulation induction via gonadotropins injection.

Exclusion Criteria:

  • Any patient with prior history of IVF injectable use will be excluded from the study.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:其他
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
其他:Nurse instruction
Traditional injection teaching method. No video instruction
Nurse directed instruction
其他:Video instruction
Video instruction that can be paused/repeated by subject
Patient Directed Video Instruction

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Tthe level of knowledge after the intervention measured by a multiple choice post-test
大体时间:approximately 1 hour
multiple choice post-test regarding their knowledge of injectable medication use
approximately 1 hour

次要结果测量

结果测量
大体时间
Satisfaction with education measured by the Likert scale survey
大体时间:post intervention
post intervention

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Michelle Matthews, MD、Wake Forest University Health Sciences

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2012年6月1日

初级完成 (实际的)

2014年4月1日

研究完成 (实际的)

2015年4月1日

研究注册日期

首次提交

2015年4月13日

首先提交符合 QC 标准的

2015年4月17日

首次发布 (估计)

2015年4月20日

研究记录更新

最后更新发布 (实际的)

2022年4月25日

上次提交的符合 QC 标准的更新

2022年4月19日

最后验证

2015年4月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • 06-12-10E

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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