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临床试验/NCT04693780
NCT04693780已完成不适用

Randomized Controlled Trial of Citizen-targeted Evidence-based Resources for Patients, Family Members and Caregivers Seeking Health Information

McMaster University2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2021年4月19日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
200
试验地点
2
主要终点
Website logins

研究概览

简要总结

The purpose of this study is to determine whether an online resource developed to aid health consumers in making health decisions and better support them to seek quality evidence before other evidence is effective in the context of inflammatory bowel disease and irritable bowel syndrome

详细描述

Participants who consent to participate in the study will be randomly allocated to either the intervention or control group.

Once logged into the website, participants in the intervention group will navigate health information through an annotated structured guide to health evidence (see Appendix 2) which is designed to inform participants where to find specific health information but it will also provide information to understand why such content is more valuable than other content. This structured annotated guide to evidence will also outline the value of pre-appraisal and will help them navigate to products produced for them. These products have been produced by the research team and include a collection of web resource ratings, evidence summaries and blog posts modelled after those developed and presented on the McMaster Optimal Aging Portal.

Once logged into the website, participants in the control group will navigate health information through a structured one-page guide (see Appendix 1) that does not include pre-appraisal information. Instead it will list the main organizations in the field that produce citizen content with descriptions of the type of content they produce with links to their individual websites. This will be presented to participants when they login to the platform. None of the citizen content produced specifically for the study will be provided to them prior to crossing-over.

All participants will receive periodic reminders to access the content in the form of an email sent every two weeks.

Both the intervention and control groups will continue for three months. After three months, the control group will be sent a message highlighting some additions to the content provided to them. From his point forward when they login to the system they will be presented with the same content that was previously only available to the intervention group. Providing those in the control group access to the same material as the intervention group for a period of the study will allow for direct within- group comparison as well as a direct comparison between groups. Both groups will continue in this manner for an additional three months.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Health Services Research
盲法
Triple (Participant, Investigator, Outcomes Assessor)

盲法说明

Once randomized, each participant will be allocated to their respective group by the website programmers who will allocate based on identification number and will not be privy to personal information regarding the participants.

入排标准

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

入选标准

  • Patients, caregivers or family members
  • Aged 18 and above
  • Have lived experience with, and are seeking information about, any of inflammatory bowel disease (i.e. Crohn's disease and ulcerative colitis), or irritable bowel syndrome
  • The study may also include, but will not initial target/recruit, patients, caregivers or family members, aged 18 and above, who have lived experience with, and are seeking information about all other gastrointestinal conditions and their symptoms (including abdominal pain, bloating, constipation, cramping, diarrhea, fatigue, gas, loss of appetite, nausea, and stools with mucus), microbiome and metabolomics, and celiac disease.

排除标准

  • 未提供

结局指标

主要结局

Website logins

时间窗: Three months

The primary outcome of the study is number of logins to the website that contains the health information (each log-in will be tracked using Google Analytics)

次要结局

  • Self-reported change in information usage(Baseline, 3 months, and 6 months)
  • Clicks on resources(Three months before cross-over and three months after cross-over)
  • Time on website(Three months before cross-over and three months after cross-over)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

John Lavis

Professor

McMaster University

研究点 (2)

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