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XerostomiaMEPNCT05964959

A Mouth Education Program for Dry Mouth

A study testing Mouth Educational Program and Care as Usual in people with Xerostomia and End of Life, run by Leiden University Medical Center at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Xerostomia, End of Life, Frailty
What is being tested?
Mouth Educational Program and Care as Usual
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
1 siteNetherlands
Study dates
15 Jun 2023to 15 Apr 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • Onze Lieve Vrouwe Gasthuis (OLVG)

    Amsterdam

Other trials in Netherlands

About this study

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

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.

Read more

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).

Being tested
Mouth Educational Program, Care as Usual
Keywords
Palliative Care, Educational Program, Oral Health
Medical subject headings
Xerostomia, Death, Frailty

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mouth Educational ProgramOther

    The Mouth Educational Program is a nurse-led patient education program for dry mouth in patients with a life-limiting condition or frailty.

  • Care as UsualOther

    Care as usual is defined as the standard dry mouth care as provided by participants' own treating physicians.

Study groups in NCT05964959
Study groupRoleWhat they receive
InterventionExperimentalIn 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.
Receives: Other: Mouth Educational Program
ControlActive comparatorThe control group will receive care as usual, provided by their trusted, treating clinicians and care teams. Questionnaires will be administered by researchers.
Receives: Other: Care as Usual

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline to Week 4

Secondary outcomes (7)

  1. 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.

    Measured: Baseline to week 2, 4, 8 and 12

  2. 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.

    Measured: Baseline to Week 8 and 12

  3. 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.

    Measured: Baseline to week 2, 4, 8 and 12

  4. 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.

    Measured: Week 4 to Week 8 and 12

  5. 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.

    Measured: Baseline to week 2, 4, 8 and 12

  6. 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.

    Measured: Baseline to week 2, 4, 8 and 12

  7. 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.

    Measured: Baseline to week 2, 4, 8 and 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jul 2023
  2. Study start15 Jun 2023
  3. Primary completion31 Dec 2024
  4. Study completion15 Apr 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
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)
Enrolment
70 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05964959
Sponsor's protocol ID
NL08440012010001
Acronym
MEP
Status last verified
Apr 2026
First submitted
30 Jun 2023
Last updated
21 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The full IPD sharing plan or data sharing agreement can be provided upon request, but is based on the FAIR data sharing principles.

Publications

  • van der Meulen AI, Neis EPJG, de Nijs EJM, Coenegracht BJEG, Stoppelenburg A, van den Beuken-van Everdingen MHJ, van der Linden YM. Dry mouth in patients with a life-limiting condition or frailty: a study protocol for two intervention studies and a nested qualitative sub-study (the Dry mOuth Project, DROP). BMC Palliat Care. 2023 Aug 23;22(1):120. doi: 10.1186/s12904-023-01242-0.

    PubMed 37612654

Questions about this trial

What is this clinical trial studying?

A study testing Mouth Educational Program and Care as Usual in people with Xerostomia and End of Life, run by Leiden University Medical Center at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage responders at week 4, as compared to baseline in both groups (time frame: Baseline to Week 4). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05964959, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2026.

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