Validating the Impact of Smell Testing on Health Outcomes and Provider Engagement.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Measuring depression symptoms using the PHQ-9 score
研究概览
简要总结
Smell dysfunction is frequent yet neglected. The sense of smell plays a crucial role in signaling disease, safety, and overall quality of life. However, the significance of a functional sense of smell in terms of health and well-being is often overlooked until one experiences a loss of smell due to injury or disease. Research demonstrates that individuals are often not self-aware of their smell dysfunction (i.e. they do not spontaneously report smell dysfunction as a symptom), especially if the changes are gradual, as in normal aging. Patients with smell dysfunction experience a marked reduction in quality of life, poor mental health, nutritional health, and brain health as well as increased 5- and 10-year mortality in older adults. This study explores whether or not enabling healthcare providers to offer resources and guidance on coping strategies for smell dysfunction improves health and wellbeing in those who experience it.
详细描述
The investigators will recruit participants in cycles for in person or remote participation. Each cycle is characterized by an initial assessment, intervention deployment (smell testing), post-intervention evaluation, 1-month and 6-month follow-ups via survey, text or phone to assess post-intervention psychological health and connection to care for smell dysfunction. The research team will assess odor detection, intensity, identification, pleasantness and discrimination. Based on the cut-offs determined prior to the beginning of data collection, the investigators will prospectively assign a participant to the smell dysfunction group or to the normosmia (no smell dysfunction) group. Based on this diagnostic intervention, participants with smell dysfunction will receive patient-centered information and education about i) community engagement with individuals with smell loss, ii) available counseling and iii) medical support. At the end of the 1-month and 6-month follow-up periods, the investigators will assess effectiveness of the intervention using pre-post comparisons to determine whether individuals taking a smell test felt improvements in their psychological health and whether they have contacted a provider and/or followed up with a visit.
Sessions may include multiple surveys/instruments depending on the session number. Specifically, emotional ratings and demographic information will be collected by means of either a paper - or computer-based questionnaire. A survey to measure psychological health and quality of life will be given to participants, as well as a questionnaire to measure depression, which is associated with smell dysfunction. Participants will answer questions about how they are feeling and how ready they are to contact a healthcare provider. The specific smell tests that will be given to participants will be either SCENTinel, NIH Toolbox, Arohma, or the B-SIT test. Other Follow-Up Questions include ones regarding access to care, contacting a provider, seeing a provider, and satisfaction with care.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 7 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •- Can read and understand English and have access to a reliable internet connection and a smart device or computer for the duration of the experimental sessions, unless they are part of community events in which smart devices are provided
排除标准
- •- Known intolerance or allergy to any of the odor stimuli used
研究组 & 干预措施
Normosmia
No intervention
Smell dysfunction detection and educational intervention
Participants will take smell tests and receive educational materials on smell dysfunction.
干预措施: Patient-centered information and education (Behavioral)
结局指标
主要结局
Measuring depression symptoms using the PHQ-9 score
时间窗: PHQ-9 is completed at baseline, during 1 month follow-up session, and during the 6 month follow-up.
The PHQ-9 is a screening measure of depressive symptoms.
次要结局
- Measuring health-related quality of life using the SF-12 survey.(SF-12 is completed at baseline, during 1 month follow-up session, and during the 6 month follow-up.)
- Measuring self-reported health perception using a "How do you feel?" 0-100 Visual Analogue Scale (VAS).(VAS is completed at baseline, during 1 month follow-up session, and during the 6 month follow-up.)
- Effectiveness of implementation (to contact a healthcare provider for smell dysfunction within up to 6 months from smell testing).(Evaluated during 1 month and 6 month follow ups)
研究者
Valentina Parma
Assistant Member and Senior Director of Multisector Engagements
Monell Chemical Senses Center