Edinburgh and Lothians Viral Intervention Study (ELVIS). A Pilot Randomised Control Trial of Hypertonic Saline Nasal Irrigation and Gargling on Individuals With the Common Cold to Assess Recruitment, Retention, Side Effects & Effectiveness
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- NHS Lothian
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- What is the recruitment rate?
研究概览
简要总结
Viral upper respiratory tract infections (URTI), one of the commonest infection faced by humans, have a significant impact on individuals, families, health service and economy. Though rhinoviruses are called the "common cold virus", numerous viruses can cause URTI. Hence virus specific remedy for URTI is impractical. There are currently no evidence-based interventions that reduce the severity, symptom duration or viral shedding. Preliminary evidence suggests that hypertonic saline nasal irrigation and gargling (HSNIG) may reduce the duration of symptoms.
With this pilot randomised controlled trial (RCT), the investigators aim to assess the feasibility of undertaking a definitive RCT of HSNIG in adults with URTI. This pilot focuses on recruitment rate, willingness to be randomised, acceptability, compliance and likely effect size of the intervention.
This pilot RCT compares HSNIG vs. usual care in 60 adults. Serial self-collected mid-turbinate swabs will help assess change in viral shedding. Symptomatic relief is measured by a validated symptom score. A questionnaire based participant feedback will help assess intervention and trial procedures.
This mixed-methods pilot trial will help inform plans for a definitive RCT of this low-cost intervention that has the potential of substantial health and societal benefits.
详细描述
- Aims:
To assess the feasibility of undertaking a RCT of HSNIG in adults with URTI focusing on recruitment rate, willingness to be randomised, acceptability, compliance and likely effect size of the intervention.
1.1. Research questions:
- What is the likely rate of recruitment and loss to follow-up?
- Are the study procedures acceptable to participants?
- Is there a likely reduction in duration of symptoms and viral shedding?
- What effect size is estimated for the definitive trial in relation to duration of symptoms and improvement in quality-of-life?
- Subjects:
2.1 Sample size: This is a pilot trial so no formal sample size calculations are indicated. However, with a sample size of 27 per group the investigators would be able to express the proportion of those who return the symptom score diary and samples within that group to within ±19% based on a two-sided 95% confidence interval around an expected proportion of 0.5. With the two groups combined [i.e. a sample size of 54] the investigators would be able to express a proportion to within ±13%. To allow for 10% dropouts the sample size has been increased to 30 per group.
2.2 Recruitment: The investigators propose to enrol a total of 60 participants (30/arm) for this pilot. The investigators plan to recruit by advertising the study in the community by the following routes.
- Sending flyers to parents through schools run by Edinburgh and Midlothian councils.
- Study website (www.elvisstudy.com), National Health Service (NHS) Lothian, University of Edinburgh websites.
- Local media coverage by way of interviews.
- Flyers in workplaces with large numbers of staff (e.g. banks, supermarkets, councils).
- Posters in pharmacies and General practitioner (GP) surgeries.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of upper respiratory tract infection (URTI)
- •Within 48 hours of onset
排除标准
- •Onset of URTI >48 hours
- •On antibiotics
- •Pregnancy
- •History of chronic illness or immunosuppression
- •Allergic rhinitis
- •Unable to perform nasal irrigation and gargling
- •Taking part in another medical trial
研究组 & 干预措施
Nasal Irrigation & Gargling
Videos on how to collect nasal swabs, prepare and perform hypertonic saline nasal irrigation and gargling (HSNIG) are shown. A nasal swab is collected. Participant chooses the highest concentration of hypertonic saline he/she is comfortable with (from 1.5, 2.0, 2.5 and 3.0%) and performs HSNIG under observation. Nasal swabs are to be collected first thing in the morning on 4 consecutive days and posted using the Royal Mail Safebox. Daily diaries are to be completed (online / paper form) until they document "not unwell" for two consecutive days; or a maximum of 14 days or if they need medical attention for the URTI. Swabs are tested in parallel to detect change in viral shedding.
干预措施: Nasal Irrigation & Gargling (Other)
Control
The control group are advised to manage the URTI as they normally do. A video on how to collect nasal swabs is shown. A nasal swab is collected. Nasal swabs are to be collected first thing in the morning on 4 consecutive days and posted using the Royal Mail Safebox. Daily diaries are to be completed (online / paper form) until they document "not unwell" for two consecutive days; or a maximum of 14 days or if they need medical attention for the URTI. Swabs are tested in parallel to detect change in viral shedding.
结局指标
主要结局
What is the recruitment rate?
时间窗: 6 months
A standard accrual plot will be produced, a plot of number of participants recruited in each week and the recruitment rate will be expressed as the average number of participants recruited per week over the duration of the study period. A table showing number of participants recruited by site will also be produced.
次要结局
- Is there a difference between arms in the duration of symptoms or viral shedding?(6 months)
- What is the rate of diary completion within the two arms?(6 months)
- Do the participants comply with the intervention regime?(6 months)
- What are the participant views on acceptability?(6 months)
- What is the rate of sample return within the two arms?(6 months)
- Is there a difference between arms in their quality-of-life?(6 months)
研究者
Dr. Sandeep Ramalingam
Consultant Virologist
NHS Lothian