A Mouth Education Program for Dry Mouth
- Conditions
- FrailtyDry MouthEnd of LifeXerostomia
- Interventions
- Other: Care as UsualOther: Mouth Educational Program
- Registration Number
- NCT05964959
- Lead Sponsor
- Leiden University Medical Center
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 228
- 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)
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control Care as Usual The control group will receive care as usual, provided by their trusted, treating clinicians and care teams. Questionnaires will be administered by researchers. Intervention Mouth Educational Program 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.
- Primary Outcome Measures
Name Time Method Percentage responders at week 4, as compared to baseline in both groups 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.
- Secondary Outcome Measures
Name Time Method Change in dry mouth symptoms upon MEP participation as compared to the control group Baseline to week 2, 4, 8 and 12 Dry mouth symptoms are measured by the summated Xerostomia Inventory-Dutch Version (sXI-D). The sXI-D contains 5 items adressing dry mouth in general, dry mouth during eating, difficulty eating, difficulty swallowing and dry lips. Here, three items have been added: oral pain, difficulty speaking and change in taste. The sXI-D scale ranges from 0=never, 1=occassionally to 2=often.
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 mean NRS dry mouth scores in the MEP group at all time-points when compared to the control group. The NRS ranges from 0=no dry mouth to 10=worst possible dry mouth.
Change in Global Perceived Effect by participants upon MEP participation, as compared to the control group Baseline to week 2, 4, 8 and 12 GPE by participants is determined using a 7-point GPE scale. The GPE addresses perceived improvement of their condition, ranging from 1=very good, 2=good, 3=fairly good, 4=same as before, 5=fairly bad, 6=bad, 7=very bad.
Percentage responders at week 8 and 12, as compared to baseline in both groups Baseline to Week 8 and 12 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.
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 The OHRQoL is measured using the validated Dutch version of the Geriatric Oral Health Assessment Index (GOHAI-NL). The GOHAI-NL contains 12 items in three categories: phsyical function, psychosocial function and pain/discomfort, and uses a 5-point Likert scale ranging from 0=never to 5=often/always.
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 The HRQoL is assessed using the EuroQoL five-demensional five-level questionnaire (EQ-5D-5L). The EQ-4D-4L contains five dimensions of health: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 answer categories (levels): 0=no problems, 1=some problems, 2=moderate problems, 3=severe problems, and 4=extreme problems/unable to.
Change in clinical functioning upon MEP participation, as compared to the control group Baseline to week 2, 4, 8 and 12 Clinical functioning is examined by a patient-reported functional status (PRFS) scale. The PRFS was originally part of the validated Patient-Generated Subjective Global Assessment (PG-SGA) but has also been validated as a stand-alone measure. Activities and function are measured on a five-point scale, with the following definitions: 0= normal with no limitations, 1=not my normal self, but able to be up and about with fairly normal activities, 2=not feeling up to most things, but in bed or chair less than half of the day, 3=able to do little activity and spend most of the day in bed or chair, 4=bed ridden, rarely out of bed.
Trial Locations
- Locations (1)
Onze Lieve Vrouwe Gasthuis (OLVG)
🇳🇱Amsterdam, Netherlands