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Search / Trial NCT05964959

A Mouth Education Program for Dry Mouth

Launched by LEIDEN UNIVERSITY MEDICAL CENTER · Jul 27, 2023

Trial Information

Current as of July 26, 2025

Recruiting

Keywords

Palliative Care Educational Program Oral Health

ClinConnect Summary

This clinical trial is studying a program called the Mouth Educational Program (MEP), which aims to help patients experiencing dry mouth, especially those with serious health conditions or frailty. The trial will see if this nurse-led education can effectively reduce complaints of dry mouth by teaching patients about its causes and providing personalized treatment plans based on the latest guidelines. Participants will be divided into two groups: one will receive the MEP, while the other will continue with standard care.

To be eligible for the trial, participants must be at least 18 years old, have a life-limiting condition or frailty, and report a significant level of dry mouth. Participants will complete questionnaires to share their experiences and, if in the intervention group, they will take part in the MEP sessions. It's important to note that individuals with a very short life expectancy or certain medical histories may not qualify for the study. Overall, this trial aims to provide more support for patients struggling with dry mouth, helping improve their comfort and quality of life.

Gender

ALL

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)

About Leiden University Medical Center

Leiden University Medical Center (LUMC) is a prominent academic medical center located in the Netherlands, renowned for its commitment to advancing healthcare through innovative research and high-quality patient care. As a clinical trial sponsor, LUMC focuses on translating scientific discoveries into effective therapies, fostering collaborations between researchers, clinicians, and industry partners. The center is dedicated to conducting rigorous clinical studies across various medical fields, ensuring adherence to ethical standards and regulatory requirements while prioritizing patient safety and outcomes. Through its multidisciplinary approach, LUMC aims to contribute significantly to the understanding and treatment of complex health conditions, driving progress in personalized medicine and improving global health.

Locations

Amsterdam, , Netherlands

Patients applied

0 patients applied

Trial Officials

Yvette M van der Linden, Prof. dr.

Principal Investigator

Leiden University Medical Centre

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported