Dry Mouth, End of Life, Frailty, Xerostomia
Conditions
Keywords
Palliative Care, Educational Program, Oral Health
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 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).
Interventions
OTHERMouth 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.
OTHERCare as Usual
Care as usual is defined as the standard dry mouth care as provided by participants' own treating physicians.
Sponsors
Leiden University Medical Center
ZonMw: The Netherlands Organisation for Health Research and Development
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
A cluster-based intervention study in 6 hospitals and 6 nursing homes (n=228), followed by a mixed-methods study and cost-effective analysis.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage responders at week 4, as compared to baseline in both groups | Baseline to Week 4 | A responder is defined as a participant with a clinically relevant response, i.e. at least a 2-point reduction on the 11-point Numeric Rating Score (NRS) for dry mouth severity. The NRS ranges from 0=no dry mouth to 10=worst possible dry mouth. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in mean Numeric Rating Score (NRS) for dry mouth severity upon MEP participation, as compared to the control group | Baseline to week 2, 4, 8 and 12 | Change in mean NRS dry mouth scores in the MEP group at all time-points when compared to the control group. The NRS ranges from 0=no dry mouth to 10=worst possible dry mouth. |
| Percentage responders at week 8 and 12, as compared to baseline in both groups | Baseline to Week 8 and 12 | A responder is defined as a participant with a clinically relevant response, i.e. at least a 2-point reduction on the 11-point Numeric Rating Score (NRS) for dry mouth severity. The NRS ranges from 0=no dry mouth to 10=worst possible dry mouth. |
| Change in dry mouth symptoms upon MEP participation as compared to the control group | Baseline to week 2, 4, 8 and 12 | Dry mouth symptoms are measured by the summated Xerostomia Inventory-Dutch Version (sXI-D). The sXI-D contains 5 items adressing dry mouth in general, dry mouth during eating, difficulty eating, difficulty swallowing and dry lips. Here, three items have been added: oral pain, difficulty speaking and change in taste. The sXI-D scale ranges from 0=never, 1=occassionally to 2=often. |
| Change in Oral Health-Related Quality of Life (OHRQoL) upon MEP participation, as compared to the control group | Week 4 to Week 8 and 12 | The OHRQoL is measured using the validated Dutch version of the Geriatric Oral Health Assessment Index (GOHAI-NL). The GOHAI-NL contains 12 items in three categories: phsyical function, psychosocial function and pain/discomfort, and uses a 5-point Likert scale ranging from 0=never to 5=often/always. |
| Change in clinical functioning upon MEP participation, as compared to the control group | Baseline to week 2, 4, 8 and 12 | Clinical functioning is examined by a patient-reported functional status (PRFS) scale. The PRFS was originally part of the validated Patient-Generated Subjective Global Assessment (PG-SGA) but has also been validated as a stand-alone measure. Activities and function are measured on a five-point scale, with the following definitions: 0= normal with no limitations, 1=not my normal self, but able to be up and about with fairly normal activities, 2=not feeling up to most things, but in bed or chair less than half of the day, 3=able to do little activity and spend most of the day in bed or chair, 4=bed ridden, rarely out of bed. |
| Change in Global Perceived Effect by participants upon MEP participation, as compared to the control group | Baseline to week 2, 4, 8 and 12 | GPE by participants is determined using a 7-point GPE scale. The GPE addresses perceived improvement of their condition, ranging from 1=very good, 2=good, 3=fairly good, 4=same as before, 5=fairly bad, 6=bad, 7=very bad. |
| Change in Health Related Quality of Life (HRQoL) upon MEP participation, as compared to the control group | Baseline to week 2, 4, 8 and 12 | The HRQoL is assessed using the EuroQoL five-demensional five-level questionnaire (EQ-5D-5L). The EQ-4D-4L contains five dimensions of health: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 answer categories (levels): 0=no problems, 1=some problems, 2=moderate problems, 3=severe problems, and 4=extreme problems/unable to. |
Countries
Netherlands
Contacts
PRINCIPAL_INVESTIGATORYvette M van der Linden, Prof. dr.
Leiden University Medical Centre
Outcome results
None listed