Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
228 participants
INTERVENTIONAL
2023-06-15
2026-05-31
Brief Summary
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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).
Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Intervention
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.
Mouth Educational Program
The Mouth Educational Program is a nurse-led patient education program for dry mouth in patients with a life-limiting condition or frailty.
Control
The control group will receive care as usual, provided by their trusted, treating clinicians and care teams. Questionnaires will be administered by researchers.
Care as Usual
Care as usual is defined as the standard dry mouth care as provided by participants' own treating physicians.
Interventions
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Mouth Educational Program
The Mouth Educational Program is a nurse-led patient education program for dry mouth in patients with a life-limiting condition or frailty.
Care as Usual
Care as usual is defined as the standard dry mouth care as provided by participants' own treating physicians.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
ALL
No
Sponsors
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ZonMw: The Netherlands Organisation for Health Research and Development
OTHER
Leiden University Medical Center
OTHER
Responsible Party
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Yvette M. van der Linden
Prof. dr.
Principal Investigators
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Yvette M van der Linden, Prof. dr.
Role: PRINCIPAL_INVESTIGATOR
Leiden University Medical Centre
Locations
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Onze Lieve Vrouwe Gasthuis (OLVG)
Amsterdam, , Netherlands
Countries
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Central Contacts
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Facility Contacts
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Annelot I van der Meulen, MSc
Role: primary
References
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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.
Other Identifiers
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NL08440012010001
Identifier Type: -
Identifier Source: org_study_id