CompletedNot Applicable

The Oral Symptom Assessment Scale in Older Patients With Frailty

Ireland250 participantsStarted 2023-06-06

Plain-language 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.

Who can participate

Age range

65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

To determine the prevalence of oral symptoms in older patients with frailty

Timeframe: 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)

Timeframe: In the previous 1 week

To determine the relationship between oral symptoms and Clinical Frailty Score / Cumulative Illness Rating Scale for Geriatrics/Medications

Timeframe: In the previous 1 week

To provide initial validation of OSAS in older patients with frailty

Timeframe: In the previous 1 week

Trial details

NCT IDNCT06286982

SponsorOur Lady's Hospice and Care Services

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-07-04

View on ClinicalTrials.gov More Frailty trials

Plain-language summary

Who can participate

Age range

65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

To determine the prevalence of oral symptoms in older patients with frailty

Timeframe: 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)

Timeframe: In the previous 1 week

To determine the relationship between oral symptoms and Clinical Frailty Score / Cumulative Illness Rating Scale for Geriatrics/Medications

Timeframe: In the previous 1 week

To provide initial validation of OSAS in older patients with frailty

Timeframe: In the previous 1 week