Prospective, Multicenter Study to measure the impact of a speaking bOok on patient UNderstanDing of clinical research knowledge: The SOUND Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 205
- 试验地点
- 2
- 主要终点
- To evaluate the Improvement in clinical trial knowledge with the Speaking Book. At least a 25 percent improvement in willingness
研究概览
简要总结
Prospective, multicentre, qualitative research study to measure the impact of a Speaking Book on patient understanding of clinical trials.
A series of 3 questionnaires (see Annex 1) to assess baseline level knowledge of clinical trials including perception of common misunderstandings and the impact and ease of the Speaking Book on increasing the level of clinical trial knowledge.
This study also aims to highlight the patient groups needing most support and reinforcement of understanding.
As there is NO randomisation procedure for this study, the only way blinding to the Speaking Book can be achieved is by recruiting patients to two groups.
Assignment will be done at Sponsor level consecutively by site; the site will not know which group will be getting the Speaking Book (review group) Recruitment will continue until an even number of subjects have been recruited at the center resulting in the same number of patients in both Group A and Group B (1:1 randomisation) for an even comparison within the site. Patient numbering will be assigned at the trial level by the sponsor team.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Informed consent
- •Male and females
- •Minimum age 18 years
- •Minimal literacy levels as verified by Principle Investigator/Study Team
- •Disease of benign haemoglobinopathies
- •Patients who have never participated in a clinical trial previously.
排除标准
- •Patients who are unable to comprehend or are unwilling to sign an informed consent form (ICF)
- •Any medical condition that, in the opinion of the Investigator, would interfere with completion of the study such as psychiatric.
结局指标
主要结局
To evaluate the Improvement in clinical trial knowledge with the Speaking Book. At least a 25 percent improvement in willingness
时间窗: Visit 1: Baseline and Visit 2: Approx 4 wks (+/-) 2 wks
次要结局
- To assess the willingness to participate in a clinical trial after reviewing the Speaking Book. At least a 25 percent improvement in willingness to participate in a clinical trial(Visit 1 Baseline)
研究者
Dr Dipti Jain
Arihant Multispeciality Hospital