Behaviorally Enhanced Messages to Increase Medical Check-ups
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 266
- 试验地点
- 1
- 主要终点
- Self-reported seeking of further medical attention.
研究概览
简要总结
The study had two stages. Stage 1 involved an opportunistic screening for hypertension conducted at the 2018 Beirut Marathon. During stage 1, participants whose measurements indicated hypertension were invited to take part in a RCT (randomized controlled trial). Stage 2 involved a RCT to evaluate the effectiveness of a behavioural intervention to increase the proportion of participants who sought further medical attention. The research team hypothesised that the intervention would increase the proportion of participants who sought further medical attention compared to a control group that did not receive the intervention.
This is a retrospective registration specifically focused on the RCT component of this study. The study was conducted by Nudge Lebanon in partnership with B4- development (formerly known as QBIU) and SmartScience. The RCT was not pre-registered because the collaborators were unaware that pre-registration would be necessary. The collaborators asked the University of Warwick to re-analyse and write the project up for publication after the study was complete. The University of Warwick is now seeking to retrospectively register the trial before submitting to an academic journal. The fact that this trial is retrospectively registered will be plainly stated in the manuscript and all analyses will be presented as exploratory.
详细描述
This study had two stages. Stage 1 involved an opportunistic screening and Stage 2 involved in RCT. This registration focuses on the RCT but both stages are described here.
Stage 1. The opportunistic screening for hypertension was conducted around the 2018 Beirut Marathon. Screening tents were set up at the marathon village during the four days leading up to the marathon (7-10 November), where runners collected necessary materials for the run and could take up the screening. An additional two tents were set up during the marathon day were spectators could take part. Participants indicated their consent for the screening before taking part. During their participation they completed surveys about their demographics and health information (including whether they were hypertensive). After they completed the survey, nurses and trained team members measured their blood pressure using calibrated equipment. Those participants whose measurements indicated hypertension were invited to participate in the RCT.
Stage 2. For the RCT participants were randomly assigned to either a intervention or control group in a 1:1 fashion. Participants in the intervention group were sent a WhatsApp message 25 days after the marathon reminding them to seek help for their hypertensive condition. Participants in the control group were not sent this message. Then one month later the researchers called all these participants to ask wither they sought further medical attention. The main outcome was whether participants self-reported seeking further medical attention.
The research objectives were as follows:
Stage 1 screening: Evaluate if the opportunistic screening increased people's awareness of their hypertensive condition.
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
- Single (Outcomes Assessor)
盲法说明
The researchers who called participants to ask if they sought further medical attention was not made aware of the participants' conditions.
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
- •objectively taken measurements at opportunistic screening indicated hypertension,
- •provided informed consented to participate in the trial, and
- •provided valid contact details for a smart phone with WhatsApp messenger
排除标准
- 未提供
结局指标
主要结局
Self-reported seeking of further medical attention.
时间窗: Response taken 56 days after the opportunistic screening (1 = Yes-sought further medical attention, 0 = No)
If participants tell the researcher that they sought further medical attention via a phone call they received approximately 1 month after the WhatsApp messages were sent to participants.
次要结局
- Self-reported Diabetes(A survey response taken at the opportunistic screening.(1 = Yes-experiencing diabetes, 0 = No))
- Self-reported High Cholesterol(A survey response taken at the opportunistic screening.(1 = Yes-experiencing high cholesterol, 0 = No))
- Diastolic blood pressure (DBP)(An objective measure taken at the opportunistic screening using an Omron 5 Series BP742N blood pressure monitor)
- Self-reported Hypertension(A survey response taken at the opportunistic screening.(1 = Yes-experiencing hypertension, 0 = No))
- Systolic blood pressure (SBP)(An objective measure taken at the opportunistic screening using an Omron 5 Series BP742N blood pressure monitor)
研究者
Kelly Ann Schmidtke
Assistant Professor
University of Warwick