Clinical trial NCT05964959: A Mouth Education Program for Dry Mouth
Official title: Dry Mouth in Patients With a Life-limiting Condition or Frailty: the Effect of a Nurse-led Patient Education Program
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Xerostomia
End of Life
Frailty
Dry Mouth
Keywords: Palliative Care
Educational Program
Oral Health
Lead sponsor: Leiden University Medical Center
Sponsor class: OTHER
Collaborators: name: ZonMw: The Netherlands Organisation for Health Research and Development
First posted: 2023-07-28
Enrollment: 228
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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).


Eligibility criteria: 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)

Primary outcomes:
measure: Percentage responders at week 4, as compared to baseline in both groups
timeFrame: Baseline to Week 4
Secondary outcomes:
measure: Change in mean Numeric Rating Score (NRS) for dry mouth severity upon MEP participation, as compared to the control group
timeFrame: Baseline to week 2, 4, 8 and 12
measure: Percentage responders at week 8 and 12, as compared to baseline in both groups
timeFrame: Baseline to Week 8 and 12
measure: Change in dry mouth symptoms upon MEP participation as compared to the control group
timeFrame: Baseline to week 2, 4, 8 and 12
measure: Change in Oral Health-Related Quality of Life (OHRQoL) upon MEP participation, as compared to the control group
timeFrame: Week 4 to Week 8 and 12
measure: Change in clinical functioning upon MEP participation, as compared to the control group
timeFrame: Baseline to week 2, 4, 8 and 12
measure: Change in Global Perceived Effect by participants upon MEP participation, as compared to the control group
timeFrame: Baseline to week 2, 4, 8 and 12
measure: Change in Health Related Quality of Life (HRQoL) upon MEP participation, as compared to the control group
timeFrame: Baseline to week 2, 4, 8 and 12
Other outcomes:
measure: Current clinical practices in dry mouth care as reported by health care professionals in both the control and intervention group (nurses and medical doctors)
timeFrame: At baseline and upon full study completion per study site (expected after an average of 1 year)
measure: Current clinical practices in dry mouth care as experienced by participants in the control group
timeFrame: Week 12
measure: Barriers and facilitators of the MEP as perceived by nurses participating in the intervention group.
timeFrame: Upon study completion, after an average of 1 year
measure: Barriers, facilitators and overall applicability of the MEP as a means to structurally implement the existing guidelines as perceived by nurses participating in the intervention group.
timeFrame: Upon study completion, after an average of 1 year
measure: Barriers and facilitators of the MEP as perceived by participants in the intervention group.
timeFrame: Upon study completion, after an average of 1 year
measure: Barriers and facilitators of the current guidelines for dry mouth care in the Netherlands as perceived by nurses in both the intervention and control group.
timeFrame: Upon study completion, after an average of 1 year
measure: Cost-effectiveness Analysis (CEA) of the MEP, as compared to the control group
timeFrame: Week 0, 4, 8 and 12.
Locations:
city: Amsterdam
country: Netherlands
facility: Onze Lieve Vrouwe Gasthuis (OLVG)
Study officials:
affiliation: Leiden University Medical Centre
name: Yvette M van der Linden, Prof. dr.
role: PRINCIPAL_INVESTIGATOR
References: