Dry Mouth in Patients With a Life-limiting Condition or Frailty: the Effect of a Nurse-led Patient Education Program
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Percentage responders at week 4, as compared to baseline in both groups
研究概览
简要总结
The goal of this cluster based intervention trial is to evaluate the effect of a nurse-led patient education program on dry mouth in patients with a life-limiting condition or frailty.
The Mouth Educational Program (MEP) is a nurse-led patient education program, in which trained nurses use current clinical, palliative dry mouth guidelines in a structured manner to discuss causes, consequences and interventions with the patients and to create an appropriate treatment plan. This intervention will be compared to a control group receiving care as usual.
Therefore, the main question it aims to answer is:
Does a nurse-led patient education program reduce dry mouth complaints in patients with a life-limiting condition or frailty?
Participants will be asked to answer questionnaires and, when part of the intervention group, partake in the Mouth Educational Program (MEP).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years or older;
- •life-limiting condition or frailty (definition from Kwaliteitskader Palliatieve Zorg Nederland (IKNL/Palliactief, 2017)),
- •experience the complaint dry mouth ≥ 5 on an 11 point numerical rating scale (ranging from 0=no dry mouth to 10=worst dry mouth ever);
- •fulfil the Surprise Question (SQ): 'Would I be surprised if my patient dies within the year? (no)
排除标准
- •life expectancy less than 4 weeks;
- •previous medical history of radiotherapy to the salivary glands or Sjogren's syndrome;
- •a cognitive inability to understand and participate in an educational program (assessed by a member of the regular care team, either doctor or nurse)
研究组 & 干预措施
Intervention
In the intervention group, the nurse and participant will be using the Mouth Education Program (MEP) to discuss causes, consequences and interventions for dry mouth in a structured manner, ultimately leading to an appropriate, individual treatment plan.
The MEP is based on current clinical, national palliative care guidelines on dry mouth care.
干预措施: Mouth Educational Program (Other)
Control
The control group will receive care as usual, provided by their trusted, treating clinicians and care teams. Questionnaires will be administered by researchers.
干预措施: Care as Usual (Other)
结局指标
主要结局
Percentage responders at week 4, as compared to baseline in both groups
时间窗: Baseline to Week 4
A responder is defined as a participant with a clinically relevant response, i.e. at least a 2-point reduction on the 11-point Numeric Rating Score (NRS) for dry mouth severity. The NRS ranges from 0=no dry mouth to 10=worst possible dry mouth.
次要结局
- Change in dry mouth symptoms upon MEP participation as compared to the control group(Baseline to week 2, 4, 8 and 12)
- Change in mean Numeric Rating Score (NRS) for dry mouth severity upon MEP participation, as compared to the control group(Baseline to week 2, 4, 8 and 12)
- Change in Global Perceived Effect by participants upon MEP participation, as compared to the control group(Baseline to week 2, 4, 8 and 12)
- Percentage responders at week 8 and 12, as compared to baseline in both groups(Baseline to Week 8 and 12)
- Change in Oral Health-Related Quality of Life (OHRQoL) upon MEP participation, as compared to the control group(Week 4 to Week 8 and 12)
- Change in Health Related Quality of Life (HRQoL) upon MEP participation, as compared to the control group(Baseline to week 2, 4, 8 and 12)
- Change in clinical functioning upon MEP participation, as compared to the control group(Baseline to week 2, 4, 8 and 12)
研究者
Yvette M. van der Linden
Prof. dr.
Leiden University Medical Center