A Mouth Education Program for Dry Mouth

Not Applicable

Recruiting

• Conditions: Frailty; Dry Mouth; End of Life; Xerostomia

• 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

Study Timeline

• Study Start: 2023-06-15
• Study First Submitted: 2023-06-30
• Status Verified: 2023-07
• Study First Submitted QC: 2023-07-27
• Last Update Submitted: 2023-07-27
• Study First Posted: 2023-07-28
• Last Update Posted: 2023-07-28
• Primary Completion: 2024-12
• Study Completion: 2026-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 228

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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.
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.
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.

Trial Locations

Locations (1)

Onze Lieve Vrouwe Gasthuis (OLVG); 🇳🇱 Amsterdam, Netherlands