A Mouth Education Program for Dry Mouth

Study Overview
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Brief Summary
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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).

Official Title
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Dry Mouth in Patients With a Life-limiting Condition or Frailty: the Effect of a Nurse-led Patient Education Program

Conditions
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Xerostomia, End of Life, Frailty, Dry Mouth

Intervention / Treatment
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* Other: Mouth Educational Program
* Other: Care as Usual


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) Exclusion Criteria: 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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A cluster-based intervention study in 6 hospitals and 6 nursing homes (n=228), followed by a mixed-methods study and cost-effective analysis.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>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. | Other: Mouth Educational Program<br>* The Mouth Educational Program is a nurse-led patient education program for dry mouth in patients with a life-limiting condition or frailty.<br>|
| Active Comparator: Control<br>The control group will receive care as usual, provided by their trusted, treating clinicians and care teams. Questionnaires will be administered by researchers. | Other: Care as Usual<br>* Care as usual is defined as the standard dry mouth care as provided by participants' own treating physicians.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage responders at week 4, as compared to baseline in both groups | 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. | Baseline to Week 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in mean Numeric Rating Score (NRS) for dry mouth severity upon MEP participation, as compared to the control group | 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. | Baseline to week 2, 4, 8 and 12 | 
| Percentage responders at week 8 and 12, as compared to baseline in both groups | 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. | Baseline to Week 8 and 12 | 
| Change in dry mouth symptoms upon MEP participation as compared to the control group | 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. | Baseline to week 2, 4, 8 and 12 | 
| Change in Oral Health-Related Quality of Life (OHRQoL) upon MEP participation, as compared to the control group | 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. | Week 4 to Week 8 and 12 | 
| Change in clinical functioning upon MEP participation, as compared to the control group | 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. | Baseline to week 2, 4, 8 and 12 | 
| Change in Global Perceived Effect by participants upon MEP participation, as compared to the control group | 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. | Baseline to week 2, 4, 8 and 12 | 
| Change in Health Related Quality of Life (HRQoL) upon MEP participation, as compared to the control group | 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. | Baseline to week 2, 4, 8 and 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Palliative Care, Educational Program, Oral Health