Assessing mouth symptoms in older patients with frailty
Oral Symptoms in Older Patients With Frailty: a Prospective Observational Study Using the Oral Symptom Assessment Scale
This study is testing a new questionnaire to see if it can help identify mouth problems in older adults who are frail.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 250 (estimated) |
| Ages | 65 Years and up |
| Sex | All |
| Sponsor | Our Lady's Hospice and Care Services Academic / other |
| Locations | 2 sites (Dublin and 1 other locations) |
| Trial ID | NCT06286982 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the suitability of the Oral Symptom Assessment Scale (OSAS) for identifying mouth symptoms in older adults living with frailty. Participants aged 65 and older will be asked about the presence, severity, and bothersomeness of various oral symptoms over the past week. The study will also gather feedback on the questionnaire itself to ensure its effectiveness. Conducted over six months at Our Lady's Hospice & Care Services and St James' Hospital, the study focuses on understanding the oral health challenges faced by frail older patients.
Who should consider this trial
Good fit: Ideal candidates for this study are older adults aged 65 and above with a clinical frailty score of 5 or higher.
Not a fit: Patients with a history of dementia or those unable to provide informed consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the assessment and management of oral symptoms in frail older adults, enhancing their overall quality of life.
How similar studies have performed: While the OSAS has been used in advanced cancer patients, this application in frail older adults is relatively novel and untested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria * Age ≥ 65 years old * Clinical Frailty Score ≥ 5 * No known history of dementia * The attending clinician should have no concerns about a participant's capacity to consent for this research Exclusion Criteria: * Inability to provide informed consent * Inability to complete the questionnaire * Abbreviated Mental Test Score -4 (AMT4) \<4
Where this trial is running
Dublin and 1 other locations
- St James's Hospital — Dublin, Ireland (Recruiting)
- Our Lady's Hospice and Care Services — Dublin, Ireland (Recruiting)
Study contacts
- Principal investigator: Davies Andrew, MB MD FRCP — Academic Department of Palliative Medicine, Our Lady's Hospice and Care Services, Dublin
- Study coordinator: Niamh M Cleary, MB MICGP
- Email: clearynm@tcd.ie
- Phone: +35387660366 (Ireland)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.