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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 660
- 试验地点
- 1
- 主要终点
- Change from baseline in the patient-reported digital health literacy measured by the Digital health literacy Instrument (DHLI) at 8 weeks
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Blinding will be maintained throughout the duration of the study to increase the objectivity of the results and to minimize the influence of participants' expectations on the study results. Participants in the control group will not receive any intervention and will be referred to the CIS brochure "Your journey through cancer", which will not include any information on how to search for cancer-related information online. In the dataset and in REDCap, the 5 randomization groups are referred to as groups A, B, C, D and E, so that it is not clear to the research staff evaluating the data which intervention the patients received.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Patients who are severely cognitively impaired due to their cancer or other illness
- •Patients who are unable to operate a digital device
研究组 & 干预措施
e-learning - intervention group 1.1
Participants in intervention group 1.1 will be given access to an e-learning environment with all the persuasive primary task support elements (reduction, tunneling, rehearsal). Participants can complete the e-learning within 2 weeks. The e-learning program takes approximately 20-45 minutes to complete.
干预措施: intervention group 1.1 - e-learning (Behavioral)
e-learning - intervention-group 1.2
Participants in intervention group 1.2 are given access to the same e-learning environment without the persuasive primary task support element, tunneling. Tunneling means that the educational content is organized step by step in separate chapters of the program. Participants can complete the e-learning within 2 weeks. The e-learning program takes approximately 20-45 minutes to complete.
干预措施: intervention-group 1.2 - e-learning (Behavioral)
e-learning - intervention-group 1.3
Participants in intervention group 1.3 are given access to the same e-learning environment without the persuasive primary task support element, rehearsal. All rehearsal elements such as quizzes will be removed from the e-learning environment. Participants can complete the e-learning within 2 weeks. The e-learning program takes approximately 20-45 minutes to complete.
干预措施: intervention-group 1.3 - e-learning (Behavioral)
PDF document - intervention-group 2
This intervention group is given access to a PDF document with the same content as in the e-learning environment. Participants can complete the website content within 2 weeks. The PDF document takes approximately 20-45 minutes to complete.
干预措施: intervention-group 2 - PDF (Behavioral)
No Intervention/ treatment as usual
The last group (treatment as usual) receives no intervention. However, they are sent a brochure that has nothing to do with digital health literacy.
结局指标
主要结局
Change from baseline in the patient-reported digital health literacy measured by the Digital health literacy Instrument (DHLI) at 8 weeks
时间窗: The questionnaire will be administered at baseline (TO), follow-up at 2 weeks (T1), and follow-up at 8 weeks (T8).
The primary outcome is the patient-reported digital health literacy based on the German version of the Digital health literacy Instrument (DHLI), resulting from the mean of the 21 items included. All 21 items are answered on a four-point scale (1="very difficult" to 4="very easy" and from 1="never" to 4="often"). A higher mean score indicates higher digital health literacy.
次要结局
- Digital health literacy measured with the performance-based items of the DHLI(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)(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.(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.(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.(The questionnaire will be administered at follow-up at 2 weeks (T1).)