A program to educate patients about managing dry mouth
Dry Mouth in Patients With a Life-limiting Condition or Frailty: the Effect of a Nurse-led Patient Education Program
This study tests if a special program led by nurses can help people with dry mouth, especially those who are seriously ill or frail, manage their symptoms better than standard care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 228 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Leiden University Medical Center Academic / other |
| Locations | 1 site (Amsterdam) |
| Trial ID | NCT05964959 on ClinicalTrials.gov |
What this trial studies
This intervention focuses on a nurse-led educational program designed to help patients with dry mouth, particularly those facing life-limiting conditions or frailty. Trained nurses will guide participants through the causes, consequences, and management strategies for dry mouth, using established clinical guidelines. The effectiveness of this program will be compared to a control group receiving standard care, with participants providing feedback through questionnaires. The primary aim is to determine if this structured education can alleviate dry mouth symptoms in the target population.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with a life-limiting condition or frailty who experience significant dry mouth symptoms.
Not a fit: Patients with a life expectancy of less than four weeks or those with cognitive impairments that prevent participation may not benefit from this program.
Why it matters
Potential benefit: If successful, this program could significantly improve the quality of life for patients suffering from dry mouth due to serious health conditions.
How similar studies have performed: While similar educational interventions have shown promise in improving patient outcomes, this specific approach targeting dry mouth in frail patients is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Amsterdam
- Onze Lieve Vrouwe Gasthuis (OLVG) — Amsterdam, Netherlands (Recruiting)
Study contacts
- Principal investigator: Yvette M van der Linden, Prof. dr. — Leiden University Medical Centre
- Study coordinator: Annelot I van der Meulen, MSc
- Email: aivandermeulen@lumc.nl
- Phone: 071-526 1916
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.