An observational study in Frailty and Older Adults, sponsored by Our Lady's Hospice and Care Services. Completed at 2 sites in Ireland. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2025-08-11.
Sponsored by Our Lady's Hospice and Care Services · Observational
Oral (or mouth) symptoms are common in older patients who live with frailty. It is known that frailty describes someone's overall resilience and how this relates to the chances of recovery following a health problem. A questionnaire called the Oral Symptom Assessment Scale (or OSAS) was designed to look at mouth symptoms in patients who had an advanced cancer. These symptoms may overlap with patients who have frailty.
This research study is taking place to find out if the OSAS will be a suitable questionnaire that can be used in older patients with frailty.
This study will take place in Our Lady's Hospice \& Care Services, Harold's Cross and St James' Hospital over six months.
Participants will be asked by one of our researchers about the presence or absence of 21 mouth symptoms in the last week. If present, the participant will be asked about how bothersome each symptom is as well as the severity and frequency. Up to three additional mouth symptoms that are not listed in the OSAS can be reported and rated in the same way by the participant. Participants will be asked about the questionnaire itself to provide feedback. This will take approximately 10-15 minutes to complete both.
1,199 studies on the registry are indexed under Frailty; 430 are open to participants now.
This study's enrollment of 250 is above the median of 223 across 496 observational studies indexed under Frailty.
Browse Frailty studies →Our Lady's Hospice and Care Services is the lead sponsor of 8 studies on the registry; 5 are open to participants now.
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Participants will be patients aged 65 years and older with a Clinical Frailty Score (CFS) ≥5 (as determined by the multi-disciplinary clinical team).
Exclusion Criteria:
The Oral Symptom Assessment Scale will be administered to participants. A feedback questionnaire will also be administered.
Other: Oral Symptom Assessment Scale
The Oral Symptom Assessment Scale is a patient-rated oral (or mouth) symptom assessment tool
To determine the prevalence of oral symptoms in older patients with frailty
This will be determined by participants indicating the presence ( or absence) of any one of twenty-one oral symptoms on the oral symptom assessment scale.(OSAS).
Time frame: In the previous 1 week
To determine the clinical features of these oral symptoms in this group (i.e. frequency, severity and level of distress)
If a participant indicates the presence of an oral symptom, they are asked to rate the frequency (rated : rarely (1), occasionally (2), frequently (3), almost constantly) (4), severity (rated: slight (1), moderate (2), severe (3), very severe (4)) and level of distress (rated: not at all (0.8), a little bit (1.6), somewhat (2.4), quite a bit (3.2), very much (4)) caused by each symptom. The higher the rating, the higher the frequency, severity or distress.
Time frame: In the previous 1 week
To determine the relationship between oral symptoms and Clinical Frailty Score / Cumulative Illness Rating Scale for Geriatrics/Medications
The Clinical Frailty Score (CFS) is a clinician-rated single-item written and visual chart with nine graded illustrations. The baseline of the participant in the two weeks prior to presentation should form the basis of the score as opposed to the current, immediate presentation findings. The frailty cut-off point is ≥ 5. It involves the evaluation of domains including cognition, function, and co-morbidity to produce the score. The Cumulative Illness Rating Scale for Geriatrics (CIR-G)is a scale designed to rate both the presence and severity of a disease in older persons. It encompasses information about both the long-term course and as well as current severity of a disease. It is acquired from patient medical records, interviews with patients as well as contemporaneous examination and test findings. A medication list (both regular and as needed medications) will be recorded.
Time frame: In the previous 1 week
To provide initial validation of OSAS in older patients with frailty
OSAS refers to the Oral Symptom Assessment Scale - this a twenty item patient-rated oral symptom assessment instrument which was designed and has been validated in patients with advanced cancer. The symptom of 'drooling' will be added based on investigator experience. The rating system has been outlined above.
Time frame: In the previous 1 week
Plan to share: No — The approved study protocol excludes the sharing of individual participant data with other researchers
This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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Our Lady's Hospice and Care Services