A Mouth Education Program for Dry Mouth

Frailty Clinical Trial

— MEP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05964959
• Other study ID #: NL08440012010001
• Status: Recruiting
• Phase: N/A
• Start date: June 15, 2023
• Est. completion date: May 2026

Study information

• Verified date: July 2023
• Source: Leiden University Medical Center
• Contact: Annelot I van der Meulen, MSc
• Phone: 071-526 1916
• Email: aivandermeulen[@]lumc.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 228
• Est. completion date: May 2026
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Death
• Dry Mouth
• End of Life
• Frailty
• Xerostomia

Intervention

Other:
• Mouth Educational Program
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 Usual
Care as usual is defined as the standard dry mouth care as provided by participants' own treating physicians.

Locations

Country	Name	City	State
Netherlands	Onze Lieve Vrouwe Gasthuis (OLVG)	Amsterdam

Sponsors (2)

Lead Sponsor	Collaborator
Leiden University Medical Center	ZonMw: The Netherlands Organisation for Health Research and Development

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Current clinical practices in dry mouth care as reported by health care professionals in both the control and intervention group (nurses and medical doctors)	Current clinical practices for dry mouth care as reported by health care professionals are examined by a self-developed questionnaire, including questions (open-ended and multiple choice) on work experience and education and on all aspects of clinical practice for dry mouth care (such as initial identification of dry mouth symptoms, medical anamnesis, physical examination, interventions/treatment and monitoring, and use of guidelines). The questionnaire will be administered to all participating nurses in the intervention and control group, and supplemented by at least one medical doctor per study site.	At baseline and upon full study completion per study site (expected after an average of 1 year)
Other	Current clinical practices in dry mouth care as experienced by participants in the control group	Participants' experiences in the control group (receiving care as usual) with dry mouth care are examined by individual semi-structured interviews.	Week 12
Other	Barriers and facilitators of the MEP as perceived by nurses participating in the intervention group.	Barriers and facilitators as perceived by nurses leading the MEP consultations are identified through a questionnaire, adapted from the validated Dutch Implementation of an Innovation questionnaire. This questionnaire includes personal, logistic, financial, educational and work environment barriers and facilitators.	Upon study completion, after an average of 1 year
Other	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.	The barriers, facilitators and overall applicability of the MEP as perceived by the nurses leading the MEP consultations is further explored in focus groups.	Upon study completion, after an average of 1 year
Other	Barriers and facilitators of the MEP as perceived by participants in the intervention group.	Experiences with the MEP and received care, including barriers and facilitators, by participants in the intervention group are examined by individual semi-structured interviews.	Upon study completion, after an average of 1 year
Other	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.	Barriers and facilitators of the current guidelines are examined in focus groups with nurses from either arm.	Upon study completion, after an average of 1 year
Other	Cost-effectiveness Analysis (CEA) of the MEP, as compared to the control group	The CEA is based upon patient-reported medical costs as measured by the Institute for Medical Technology Assessment (iMTA) Medical Consumption Questionnaire (iMCQ). It encompasses use of medical and paramedical treatments or services, in- and outpatient care and use of medication. Here, the questionnaire consists of three main questions asking for the frequency of contact with dental services, the frequency of contact with health care professionals across different disciplines and the purchase of dry mouth treatment products (e.g. medication and other aids) in the last four weeks.	Week 0, 4, 8 and 12.
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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