Evaluation of an Interactive E-learning Environment to Enhance Digital Health Literacy in Cancer Patients

Официальное название

Development and Effectiveness Evaluation of an Interactive E-learning Environment to Enhance Digital Health Literacy in Cancer Patients: Study Protocol for a Randomized Controlled Trial

Обзор

This study aims to create and test an online learning tool to help people with cancer improve their skills in finding and understanding health information online. The main question it aims to answer is: • Do people with cancer who use the online learning tool improve their skills more than those who don't use the tool? The investigators will test this idea in a study. The investigators will put people into different groups by chance and compare the results. 660 people with cancer will participate. These people will be chosen to represent different types of cancer. * Group 1: Uses the online learning too (3 versions) * Group 2: Uses a PDF with the same information * Control Group: Receives no intervention What Participants Will Do: Use the online tool or PDF to learn how to find reliable cancer information online. Answer questions about their digital health skills before starting, after 2 weeks, and after 8 weeks. Development: Before the start of the main study the online tool will be developed and tested. The investigators will first show a prototype of the tool to two discussion groups and use their feedback to improve it. Then, experts and people with cancer will test the final version

Подробное описание

Background: The Internet allows cancer patients to access information about their disease at any time. However, the quality of online information varies widely. Information is often inaccurate or does not provide all the details patients need to make informed decisions. Patients' often inadequate ability to find and critically evaluate cancer-related information online can lead to misinformation.

Objective: An interactive e-learning environment to promote digital health literacy will be developed and evaluated for effectiveness. The primary hypothesis is: Cancer patients who use the e-learning environment (IG1.1-IG1.3) or the content of the environment as a non-interactive PDF file (IG2) will show greater improvement in their digital health literacy from baseline to eight weeks after baseline compared to patients who do not receive such an intervention.

Methods: The hypothesis will be tested in a randomized controlled trial (RCT). In the e-learning environment, patients will learn strategies (e.g., checking information on different websites) to use when searching for reliable cancer-related online information. During the development, a prototype will be presented to two focus groups. The results of the focus groups will be implemented in a final prototype. The usability of this prototype will then be tested by usability experts and patients. 660 cancer patients will be recruited and randomly assigned in a 3:1:1 ratio to IG1.1-IG1.3 (three variants of the environment), IG2 (a PDF containing the same content as the environment), or the control group. Two thirds of the 660 participants will be recruited through the German Cancer Information Service (CIS) and one third will be recruited through non-CIS routes. A proportionally stratified sample will be drawn according to the cancer incidence. The primary outcome, digital health literacy, will be measured at baseline, two weeks, and eight weeks after baseline.

Вмешательства

• Поведенческое intervention group 1.1 - e-learning
  The e-learning environment will include text, images, and short videos created using Articulate Rise 360, an easy-to-use e-learning authoring tool, with the following content to improve the different skills of digital health literacy: 1. Evaluating reliability skills: Participants will get to know criteria and indicators for evaluating the content of the information they find and for assessing the trustworthiness of website providers. 2. Improving information skills: Participants will learn sim
• Поведенческое intervention-group 1.2 - e-learning
  Participants are also given access to the e-learning environment. However, they will not be taken step-by-step through the content (tunneling). They can choose the order of the content.
• Поведенческое intervention-group 1.3 - e-learning
  Participants are also given access to the e-learning environment, but all rehearsal elements such as quizzes will be removed from the e-learning environment.
• Поведенческое intervention-group 2 - PDF
  Participants in IG2 will receive the same content as participants in the IG1.1, but not within the interactive learning environment, but in a non-interactive PDF format.

Первичные конечные точки

• Change from baseline in the patient-reported digital health literacy measured by the Digital health literacy Instrument (DHLI) at 8 weeks [Срок оценки: The questionnaire will be administered at baseline (TO), follow-up at 2 weeks (T1), and follow-up at 8 weeks (T8).]

Вторичные конечные точки (5)

• Digital health literacy measured with the performance-based items of the DHLI [Срок оценки: The questionnaire will be administered at baseline (TO), follow-up at 2 weeks (T1), and follow-up at 8 weeks (T8).]
• Participants' motivation to use the e-learning environment measured with the Reduced Instructional Materials Motivation (RIMMS) [Срок оценки: The questionnaire will be administered at follow-up at 2 weeks (T1).]
• Acceptability of the e-learning environment as measured by the Acceptability of Intervention Measure (AIM) questionnaire. [Срок оценки: The questionnaire will be administered at follow-up at 2 weeks (T1).]
• Appropriateness of the e-learning environment as measured by the Intervention Appropriateness Measure (IAM) questionnaire. [Срок оценки: The questionnaire will be administered at follow-up at 2 weeks (T1).]
• Feasibility of the e-learning environment as measured by the Feasibility of Intervention Measure (FIM) questionnaire. [Срок оценки: The questionnaire will be administered at follow-up at 2 weeks (T1).]

Критерии участия

Критерии включения

• cancer diagnosis
• sufficient knowledge of the German language as all study content and questionnaires will be in German only
• Participants must also have and be able to use a digital device (smartphone, tablet, PC, laptop, etc.) with an internet connection
• Confirm consent to participate in the study

Критерии исключения

• Patients who are severely cognitively impaired due to their cancer or other illness
• Patients who are unable to operate a digital device

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Организация здравоохранения

Центры проведения

Германия · 1 центр

• University Medical Center Hamburg-Eppendorf — Hamburg

Идентификаторы

NCT: NCT07200453 · S-158/2024

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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