Status:
RECRUITING
A Mouth Education Program for Dry Mouth
Lead Sponsor:
Leiden University Medical Center
Collaborating Sponsors:
ZonMw: The Netherlands Organisation for Health Research and Development
Conditions:
Xerostomia
End of Life
Eligibility:
All Genders
18+ years
Phase:
NA
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 Educ...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
June 15 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2026
Estimated Enrollment :
228 Patients enrolled
Trial Details
Trial ID
NCT05964959
Start Date
June 15 2023
End Date
May 1 2026
Last Update
July 28 2023
Active Locations (1)
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1
Onze Lieve Vrouwe Gasthuis (OLVG)
Amsterdam, Netherlands