A Mouth Education Program for Dry Mouth (MEP)

Leiden University Medical Center (LUMC)

Status: Enrolling

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

Treatments: Other: Care as Usual; Other: Mouth Educational Program

Study type: Interventional

Funder types: Other

Identifiers

NCT05964959

NL08440012010001

Details and patient eligibility

About

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).

Enrollment: 228 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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228 participants in 2 patient groups

Intervention

Experimental group

Description:

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.

Treatment:

Other: Mouth Educational Program

Control

Active Comparator group

Description:

The control group will receive care as usual, provided by their trusted, treating clinicians and care teams. Questionnaires will be administered by researchers.

Treatment:

Other: Care as Usual