Clinical trial NCT06286982: The Oral Symptom Assessment Scale in Older Patients With Frailty
Official title: Oral Symptoms in Older Patients With Frailty: a Prospective Observational Study Using the Oral Symptom Assessment Scale
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Frailty
Older Adults
Keywords: Frailty
Mouth
Symptom assessment
Aged
Lead sponsor: Our Lady's Hospice and Care Services
Sponsor class: OTHER
First posted: 2024-02-29
Enrollment: 250
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be patients aged 65 years and older with a Clinical Frailty Score (CFS) ≥5 (as determined by the multi-disciplinary clinical team).

Brief summary: 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.

Detailed description: 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.

Eligibility 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

Primary outcomes:
measure: To determine the prevalence of oral symptoms in older patients with frailty
timeFrame: In the previous 1 week
measure: To determine the clinical features of these oral symptoms in this group (i.e. frequency, severity and level of distress)
timeFrame: In the previous 1 week
measure: To determine the relationship between oral symptoms and Clinical Frailty Score / Cumulative Illness Rating Scale for Geriatrics/Medications
timeFrame: In the previous 1 week
measure: To provide initial validation of OSAS in older patients with frailty
timeFrame: In the previous 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Dublin
country: Ireland
facility: St James's Hospital
city: Dublin
country: Ireland
facility: Our Lady's Hospice and Care Services
Study officials:
affiliation: Academic Department of Palliative Medicine, Our Lady's Hospice and Care Services, Dublin
name: Davies Andrew, MB MD FRCP
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lindroos EK, Saarela RKT, Suominen MH, Muurinen S, Soini H, Kautiainen H, Pitkala KH. Burden of Oral Symptoms and Its Associations With Nutrition, Well-Being, and Survival Among Nursing Home Residents. J Am Med Dir Assoc. 2019 May;20(5):537-543. doi: 10.1016/j.jamda.2018.10.025. Epub 2018 Dec 9.
citation: Saarela RKT, Savikko NM, Soini H, Muurinen S, Suominen MH, Kautiainen H, Pitkala KH. Burden of Oral Symptoms and Health-Related Quality of Life in Long-Term Care Settings in Helsinki, Finland. J Nutr Health Aging. 2019;23(10):1021-1025. doi: 10.1007/s12603-019-1268-9.
citation: Miller MD, Paradis CF, Houck PR, Mazumdar S, Stack JA, Rifai AH, Mulsant B, Reynolds CF 3rd. Rating chronic medical illness burden in geropsychiatric practice and research: application of the Cumulative Illness Rating Scale. Psychiatry Res. 1992 Mar;41(3):237-48. doi: 10.1016/0165-1781(92)90005-n.
citation: Locke T, Keat S, Tate M, Bown A, Hart A, Ghosh R. Assessing the performance of the four question abbreviated mental test in the acute geriatric setting. Acute Med. 2013;12(1):13-7.
citation: Davies A, Buchanan A, Todd J, Gregory A, Batsari KM. Oral symptoms in patients with advanced cancer: an observational study using a novel oral symptom assessment scale. Support Care Cancer. 2021 Aug;29(8):4357-4364. doi: 10.1007/s00520-020-05903-1. Epub 2021 Jan 8.
citation: Fried LP, Ferrucci L, Darer J, Williamson JD, Anderson G. Untangling the concepts of disability, frailty, and comorbidity: implications for improved targeting and care. J Gerontol A Biol Sci Med Sci. 2004 Mar;59(3):255-63. doi: 10.1093/gerona/59.3.m255.