Effectiveness of Web-based Teaching to Traditional Patient Education in the Use of Injectable Fertility Medications
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.
調査の概要
詳細な説明
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:
- 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.
- 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.
- 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.
- 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.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
North Carolina
-
Charlotte、North Carolina、アメリカ、28204
- Carolinas Medical Center - Women's Institute
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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.
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:他の
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
他の:Nurse instruction
Traditional injection teaching method.
No video instruction
|
Nurse directed instruction
|
|
他の:Video instruction
Video instruction that can be paused/repeated by subject
|
Patient Directed Video Instruction
|
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Tthe level of knowledge after the intervention measured by a multiple choice post-test
時間枠:approximately 1 hour
|
multiple choice post-test regarding their knowledge of injectable medication use
|
approximately 1 hour
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
Satisfaction with education measured by the Likert scale survey
時間枠:post intervention
|
post intervention
|
協力者と研究者
捜査官
- 主任研究者:Michelle Matthews, MD、Wake Forest University Health Sciences
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
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