跳至主要内容
临床试验/NCT03498690
NCT03498690已完成不适用

Protocol Lab for Online Trials-Delphi (PLOT-D)

ThinkWell2 个研究点 分布在 1 个国家目标入组 385 人开始时间: 2019年3月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
385
试验地点
2
主要终点
The top five disparities and similarities in ranking between interventions

研究概览

简要总结

The Protocol Lab for Online Trials-Delphi (PLOT-D) module will use an online three-round Delphi combined with Participatory action research to inform the development of a multi-use protocol template to use in writing protocols for self-recruited online trials of interventional self-management. The Delphi will include an embedded randomized controlled trial to test how and if stakeholders adapt their views based on the contributions of others inside or outside the groups with which they are familiar.

详细描述

The research aims to provide support for citizens to work alongside researchers to build participatory health trials online (any randomized trial that uses the internet for a health or wellness intervention). Tools to develop methods to run quality online trials protocols are needed. Also, help for adapting guidance to include the public and patients as partners in research for online trials is limited. The purpose of this work is to facilitate improved practice within protocol writing for participatory online trials.

Public and patient involvement (PPI), is one method used to conduct participatory research. PPI actively engages communities or individuals and moves beyond educating, engaging or doing interviews with research participants and does the research with them as partners. There is growing consensus that PPI is of value to researchers, industry, regulators, and members of the public.

There is an active discussion that is without substantial evidence for when the optimal time in the research process is to start PPI and whether patients and the public should join the research team, act as advisors, or have everyone contribute perspectives and work with their roles or peer groups.

The embedded study within the Delphi explores how working with stakeholder feedback in different ways may influence decision ranking as well choice similarities and differences

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

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

  • Protocol lab for online trials Delphi (PLOT-D) participants

排除标准

  • None if inclusion criteria are met

结局指标

主要结局

The top five disparities and similarities in ranking between interventions

时间窗: Up to 20 weeks or study completion

Prioritization of method preferences as decided by participants

次要结局

  • Differences and similarities between stakeholder groups(Up to 20 weeks or study completion)

研究者

发起方
ThinkWell
申办方类型
Other
责任方
Sponsor

研究点 (2)

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