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临床试验/NCT03021863
NCT03021863已完成不适用

How Frequently and in What Format Are Research Trial Results Disseminated to Participants? A Survey of Trialists and Response Questionnaire Trial

ThinkWell1 个研究点 分布在 1 个国家目标入组 1,198 人开始时间: 2017年1月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
1,198
试验地点
1
主要终点
Recruitment

研究概览

简要总结

Questionnaires are frequently used in online research, however recruiting, and completion rates of online participants from a variety of cultures and demographic backgrounds can be challenging. The challenge is greater in an online cohort because there is no way to observe the participant beyond what is contributed online. Poor recruiting and completion can result in underpowered research that may not be representative of the sample population. This can trigger an increase in costs as the recruitment period may have to be extended until sample size is reached. When recruiting and completion rates are inadequate studies may have to be terminated and the answer to the research question can remain unknown.

To mitigate these challenges, reminder emails are sent to questionnaire respondents. There is uncertainty about how the tone of the email reminder affects the proportion of recruitment rates.

A nested randomized trial will be used to test the intervention of tone delivery in survey email reminders to establish an evidence base. This study (ResponseQT) proposes to link with the anticipated 20,000 person international cohort study, (How Frequently and in What Format are Research Trial Results Disseminated to Participants: A Survey of Trialists (ResponseQT) to explore the evidence of effect for the research question, "Does the tone of a survey email reminder affect the proportion of survey participants recruited. The population will consist of researchers who have published a clinical trial indexed in Pub Med in 2014-15.The intervention is the tone of questionnaire email reminders and the outcomes will be the proportion of participants recruited after invitation (partial plus complete responses) following reminder 1 and 2.

详细描述

RATIONALE

Dissemination is the planned process by which results of studies are communicated to the stakeholders of that research. Stakeholders can include health policy makers, academics, practicing clinicians and other health service workers, patients, the general public, and research funders. There are multiple ways to disseminate research findings and it is often considered a shared responsibility between funders and research investigators. Traditionally, the focus has targeted healthcare professionals, policy makers, and academics through journal publications and conference presentations. However, optimal knowledge translation depends on disseminating results to all stakeholders in a way that enables them to consider the implications of the results.

Effective communication and active dissemination of research results to patients and the lay public is essential for making informed decisions and choices, but it is sometimes considered as an afterthought. Furthermore, there is no consensus on what dissemination to patients or members of the lay public means, what is the most effective dissemination process and whether research results should be disseminated to relevant patient groups and the wider public as well as the patients who took part in the studies.

Only clinical trials indexed in PubMed 2014-15 where participants were enrolled into the study will be included. We will include screening questions at the start of the survey to exclude authors of non-randomised controlled trials, preclinical, and first-in-human trials and trials where there were no study participants.

AIM

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)

入排标准

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

入选标准

  • •reports of clinical trials with human participants indexed in PubMed 2014-15

排除标准

  • •reports of laboratory or animal studies,
  • •reports of preclinical trials,
  • •reports of trials where there were no study participants

研究组 & 干预措施

Group D Reminder

Active Comparator

Tone of reminder email (duty 14 days followed by encouragement for non-responders 28 days)

干预措施: Group D Reminder (Behavioral)

Group A Reminder

Active Comparator

Tone of reminder email (duty 14 days followed by duty for non-responders 28 days)

干预措施: Group A Reminder (Behavioral)

Group B Reminder

Active Comparator

Tone of reminder email (encouragement 14 days followed by encouragement for non-responders 28 days)

干预措施: Group B Reminder (Behavioral)

Group C Reminder

Active Comparator

Tone of reminder email (encouragement 14 days followed by duty for non-responders 28 days)

干预措施: Group C Reminder (Behavioral)

Group E Reminder

Active Comparator

Tone of reminder email (generic reminders at 14 days followed by generic for non-responders 28 days)

干预措施: Group E Reminder (Behavioral)

Group F Reminder

Active Comparator

Tone of reminder email (generic 14 days followed by duty for non-responders 28 days)

干预措施: Group F Reminder (Behavioral)

Group G Reminder

Active Comparator

Tone of reminder email (generic 14 days followed by encouragement for non-responders 28 days)

干预措施: Group G Reminder (Behavioral)

Group H Reminder

Active Comparator

Tone of reminder email (duty 14 days followed by generic for non-responders 28 days)

干预措施: Group H Reminder (Behavioral)

Group I Reminder

Active Comparator

Tone of reminder email (encouragement 14 days followed by generic for non-responders 28 days)

干预措施: Group I Reminder (Behavioral)

结局指标

主要结局

Recruitment

时间窗: Duration of study up to 60 days

Proportion of sample recruited

次要结局

未报告次要终点

研究者

发起方
ThinkWell
申办方类型
Other
责任方
Sponsor

研究点 (1)

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