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FrailtyNCT06286982

The Oral Symptom Assessment Scale in Older Patients With Frailty

An observational study of Frailty and Older Adults, run by Our Lady's Hospice and Care Services at 2 sites in Ireland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Frailty, Older Adults
What is being tested?
Oral Symptom Assessment Scale
Type of treatment
Pill or oral medicine
How many people
250 participants
Where
2 sitesIreland
Study dates
6 Jun 2023to 4 Jul 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

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).

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

Ireland2 sites

  • St James's Hospital

    Dublin, Dublin, D8

  • Our Lady's Hospice and Care Services

    Dublin, Dublin, Dublin 6W

Other trials in Ireland

About this study

Official title: 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.

Read the 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.

Being tested
Oral Symptom Assessment Scale
Keywords
Frailty, Mouth, Symptom assessment, Aged
Medical subject headings
Frailty

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Oral Symptom Assessment ScaleOther

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

Study groups in NCT06286982
Study groupRoleWhat they receive
People aged 65 years and older with a Clinical Frailty Score (CFS) ≥5The Oral Symptom Assessment Scale will be administered to participants. A feedback questionnaire will also be administered.
Receives: Other: Oral Symptom Assessment Scale

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: In the previous 1 week

  2. 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.

    Measured: In the previous 1 week

  3. 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.

    Measured: In the previous 1 week

  4. 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.

    Measured: In the previous 1 week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Feb 2024
  2. Study start6 Jun 2023
  3. Primary completion4 Jul 2025
  4. Study completion4 Jul 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
250 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06286982
Sponsor's protocol ID
OASIS III
Status last verified
Jun 2025
First submitted
17 Aug 2023
Last updated
11 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The approved study protocol excludes the sharing of individual participant data with other researchers

Publications

  • 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.

    PubMed 30541688

  • 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.

    PubMed 31781733

  • 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.

    PubMed 1594710

  • 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.

    PubMed 23539371

  • 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.

    PubMed 33416995

  • 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.

    PubMed 15031310

Questions about this trial

What is this clinical trial studying?

An observational study of Frailty and Older Adults, run by Our Lady's Hospice and Care Services at 2 sites in Ireland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To determine the prevalence of oral symptoms in older patients with frailty (time frame: In the previous 1 week). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06286982, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2025.

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