The Oral Symptom Assessment Scale in Older Patients With Frailty

Oral Symptoms in Older Patients With Frailty: a Prospective Observational Study Using the Oral Symptom Assessment Scale

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.

Study Overview

• Status: Recruiting
• Conditions: Frailty; Older Adults
• Intervention / Treatment: Other: Oral Symptom Assessment Scale

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.

• Study Type: Observational
• Enrollment (Estimated): 250

Contacts and Locations

• Study Contact: Name: Niamh M Cleary, MB MICGP; Phone Number: +35387660366 (Ireland); Email: clearynm@tcd.ie

Study Locations

• Ireland
  • Dublin, Ireland, D8
    • Recruiting
    • St James's Hospital
    • Contact: Niamh Cleary, MB MICGP; Phone Number: +353876603466 (Ireland); Email: clearynm@tcd.ie
    • Sub-Investigator: Amanda Lavan, PhD MRCPI
    • Sub-Investigator: Roman Romero Ortuno, MSc PhD MRCP
  • Dublin, Ireland, Dublin 6W
    • Recruiting
    • Our Lady's Hospice and Care Services
    • Contact: Niamh M Cleary, MB MICGP; Phone Number: +353876603466 (Ireland); Email: clearynm@tcd.ie
    • Sub-Investigator: Norah Fagan, RGN MSc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

• 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).

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; The Oral Symptom Assessment Scale is a patient-rated oral (or mouth) symptom assessment tool

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 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 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

Collaborators and Investigators

• Sponsor: Our Lady's Hospice and Care Services
• Investigators: Principal Investigator: Davies Andrew, MB MD FRCP, Academic Department of Palliative Medicine, Our Lady's Hospice and Care Services, Dublin

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 6, 2023
• Primary Completion (Estimated): July 6, 2024
• Study Completion (Estimated): July 6, 2024

Study Registration Dates

• First Submitted: August 17, 2023
• First Submitted That Met QC Criteria: February 22, 2024
• First Posted (Actual): February 29, 2024

Study Record Updates

• Last Update Posted (Actual): March 7, 2024
• Last Update Submitted That Met QC Criteria: March 5, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Frailty; Aged; Symptom assessment; Mouth
• Additional Relevant MeSH Terms: Pathologic Processes; Frailty
• Other Study ID Numbers: OASIS III

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The approved study protocol excludes the sharing of individual participant data with other researchers

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No