NCT Number: NCT07222891
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.
Trial opening soon.
Get Notified7 year and older
All sexes
Interventional
Phase 2
Philadelphia, Pennsylvania, 19104, United States
Danielle Reed
PRINCIPAL_INVESTIGATOR
Pamela Dalton
PRINCIPAL_INVESTIGATOR
Ryann Kolb
CONTACT
Valentina Parma
CONTACT
Valentina Parma
PRINCIPAL_INVESTIGATOR
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 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.
Time frame: SF-12 is completed at baseline, during 1 month follow-up session, and during the 6 month follow-up.
The SF-12 is a screening measure of health-related quality of life.
Time frame: VAS is completed at baseline, during 1 month follow-up session, and during the 6 month follow-up.
"How do you feel?" VAS is a self-reported measure of health perception.
Time frame: Evaluated during 1 month and 6 month follow ups
Participants are asked a Yes or No question about whether they contacted a healthcare provider. The investigators will examine the proportion of participants connecting with a healthcare provider for smell dysfunction.
Contact information is provided by the study sponsor or research team.
Pamela Dalton
CONTACT
Valentina Parma
CONTACT
Monell Chemical Senses Center
Other
Validating the Impact of Smell Testing on Health Outcomes and Provider Engagement.
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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