A Mouth Education Program for Dry Mouth

NCT05964959 | Completed

• 1 other identifier: NL08440012010001
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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).

Conditions

Xerostomia; End of Life; Frailty; Dry Mouth

Keywords

Palliative Care; Educational Program; Oral Health

Outcome Measures

Primary Outcomes (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.

  Baseline to Week 4

Secondary Outcomes (7)

• 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

• Percentage responders at week 8 and 12, as compared to baseline in both groups

  Baseline to Week 8 and 12

• Change in dry mouth symptoms upon MEP participation as compared to the control group

  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

  Week 4 to Week 8 and 12

• Change in clinical functioning upon MEP participation, as compared to the control group

  Baseline to week 2, 4, 8 and 12

Other Outcomes (7)

• Current clinical practices in dry mouth care as reported by health care professionals in both the control and intervention group (nurses and medical doctors)

  At baseline and upon full study completion per study site (expected after an average of 1 year)

• Current clinical practices in dry mouth care as experienced by participants in the control group

  Week 12

• Barriers and facilitators of the MEP as perceived by nurses participating in the intervention group.

  Upon study completion, after an average of 1 year

Study Arms (2)

Intervention

EXPERIMENTAL

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

Control

ACTIVE COMPARATOR

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

Interventions

Mouth Educational Program OTHER

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

Intervention

Care as Usual OTHER

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

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Leiden University Medical Center: lead
• ZonMw: The Netherlands Organisation for Health Research and Development: collaborator

Study Sites (1)

Onze Lieve Vrouwe Gasthuis (OLVG)

Amsterdam, Netherlands

Location

Related Publications (1)

• 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.

  PMID: 37612654 DERIVED

MeSH Terms

Conditions

Xerostomia; Death; Frailty

Condition Hierarchy (Ancestors)

Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Yvette M van der Linden, Prof. dr.

  Leiden University Medical Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. dr.

Model Details: A cluster-based intervention study in 6 hospitals and 6 nursing homes (n=228), followed by a mixed-methods study and cost-effective analysis.

Study Record Dates

• First Submitted: June 30, 2023
• First Posted: July 28, 2023
• Study Start: June 15, 2023
• Primary Completion: December 31, 2024
• Study Completion: April 15, 2026
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Only after completion of the total study and after publication by the original researchers, will data be made available.
• Access Criteria: Data will be made available upon reasonable request by other researchers and will be decided upon on a case by case basis by the original researchers. When shared, data will be solely anonymized.

Locations

NL (1)