Oral Symptoms in Older Patients With Frailty: a Prospective Observational Study Using the Oral Symptom Assessment Scale
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 250
- 试验地点
- 2
- 主要终点
- To determine the clinical features of these oral symptoms in this group (i.e. frequency, severity and level of distress)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Inability to provide informed consent
- •Inability to complete the questionnaire
- •Abbreviated Mental Test Score -4 (AMT4) <4
结局指标
主要结局
To determine the clinical features of these oral symptoms in this group (i.e. frequency, severity and level of distress)
时间窗: In the previous 1 week
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.
To provide initial validation of OSAS in older patients with frailty
时间窗: In the previous 1 week
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.
To determine the relationship between oral symptoms and Clinical Frailty Score / Cumulative Illness Rating Scale for Geriatrics/Medications
时间窗: In the previous 1 week
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.
To determine the prevalence of oral symptoms in older patients with frailty
时间窗: In the previous 1 week
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).
次要结局
未报告次要终点
研究者
Prof Andrew Davies
Professor
Our Lady's Hospice and Care Services