The Oral Symptom Assessment Scale in Older Patients With Frailty

NCT ID: NCT06286982

Last Updated: 2025-08-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-06-06

Study Completion Date

2025-07-04

Brief Summary

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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

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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.

Conditions

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Frailty Older Adults

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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People aged 65 years and older with a Clinical Frailty Score (CFS) ≥5

The Oral Symptom Assessment Scale will be administered to participants. A feedback questionnaire will also be administered.

Oral Symptom Assessment Scale

Intervention Type OTHER

The Oral Symptom Assessment Scale is a patient-rated oral (or mouth) symptom assessment tool

Interventions

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Oral Symptom Assessment Scale

The Oral Symptom Assessment Scale is a patient-rated oral (or mouth) symptom assessment tool

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Our Lady's Hospice and Care Services

OTHER

Sponsor Role lead

Responsible Party

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Prof Andrew Davies

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Davies Andrew, MB MD FRCP

Role: PRINCIPAL_INVESTIGATOR

Academic Department of Palliative Medicine, Our Lady's Hospice and Care Services, Dublin

Locations

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St James's Hospital

Dublin, Dublin, Ireland

Site Status

Our Lady's Hospice and Care Services

Dublin, Dublin, Ireland

Site Status

Countries

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Ireland

References

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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.

Reference Type BACKGROUND
PMID: 30541688 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31781733 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 1594710 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23539371 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33416995 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15031310 (View on PubMed)

Other Identifiers

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OASIS III

Identifier Type: -

Identifier Source: org_study_id

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