The Oral Symptom Assessment Scale in Older Patients With Frailty

NCT06286982 | Completed

• 1 other identifier: OASIS III
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 2

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.

Conditions

Frailty; Older Adults

Keywords

Frailty; Mouth; Symptom assessment; Aged

Outcome Measures

Primary Outcomes (4)

• 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).

  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.

  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.

  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.

  In the previous 1 week

Study Arms (1)

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.

Other: Oral Symptom Assessment Scale

Interventions

Oral Symptom Assessment Scale OTHER

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

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

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• 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).

You may qualify if:

• 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

You may not qualify if:

• Inability to provide informed consent
• Inability to complete the questionnaire
• Abbreviated Mental Test Score -4 (AMT4) \<4

Sponsors & Collaborators

• Our Lady's Hospice and Care Services: lead

Study Sites (2)

St James's Hospital

Dublin, Dublin, D8, Ireland

Location

Our Lady's Hospice and Care Services

Dublin, Dublin, Dublin 6W, Ireland

Location

Related Publications (6)

• 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.

  PMID: 30541688 BACKGROUND

• 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.

  PMID: 31781733 BACKGROUND

• 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.

  PMID: 1594710 BACKGROUND

• 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.

  PMID: 23539371 BACKGROUND

• 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.

  PMID: 33416995 BACKGROUND

• 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.

  PMID: 15031310 BACKGROUND

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Davies Andrew, MB MD FRCP

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 17, 2023
• First Posted: February 29, 2024
• Study Start: June 6, 2023
• Primary Completion: July 4, 2025
• Study Completion: July 4, 2025
• Last Updated: August 11, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

IE (2)