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A Mouth Education Program for Dry Mouth (MEP)

Primary Purpose

Xerostomia, End of Life, Frailty

Status
Recruiting
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Mouth Educational Program
Care as Usual
Sponsored by
Leiden University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Xerostomia focused on measuring Palliative Care, Educational Program, Oral Health

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Onze Lieve Vrouwe Gasthuis (OLVG)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention

Control

Arm Description

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.

The control group will receive care as usual, provided by their trusted, treating clinicians and care teams. Questionnaires will be administered by researchers.

Outcomes

Primary Outcome Measures

Percentage responders at week 4, as compared to baseline in both groups
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 Outcome Measures

Change in mean Numeric Rating Score (NRS) for dry mouth severity upon MEP participation, as compared to the control group
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
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
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
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
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
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
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.

Full Information

First Posted
June 30, 2023
Last Updated
July 27, 2023
Sponsor
Leiden University Medical Center
Collaborators
ZonMw: The Netherlands Organisation for Health Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT05964959
Brief Title
A Mouth Education Program for Dry Mouth
Acronym
MEP
Official Title
Dry Mouth in Patients With a Life-limiting Condition or Frailty: the Effect of a Nurse-led Patient Education Program
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 15, 2023 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
May 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Leiden University Medical Center
Collaborators
ZonMw: The Netherlands Organisation for Health Research and Development

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Xerostomia, End of Life, Frailty, Dry Mouth
Keywords
Palliative Care, Educational Program, Oral Health

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
228 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
The control group will receive care as usual, provided by their trusted, treating clinicians and care teams. Questionnaires will be administered by researchers.
Intervention Type
Other
Intervention Name(s)
Mouth Educational Program
Intervention Description
The Mouth Educational Program is a nurse-led patient education program for dry mouth in patients with a life-limiting condition or frailty.
Intervention Type
Other
Intervention Name(s)
Care as Usual
Intervention Description
Care as usual is defined as the standard dry mouth care as provided by participants' own treating physicians.
Primary Outcome Measure Information:
Title
Percentage responders at week 4, as compared to baseline in both groups
Description
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.
Time Frame
Baseline to Week 4
Secondary Outcome Measure Information:
Title
Change in mean Numeric Rating Score (NRS) for dry mouth severity upon MEP participation, as compared to the control group
Description
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.
Time Frame
Baseline to week 2, 4, 8 and 12
Title
Percentage responders at week 8 and 12, as compared to baseline in both groups
Description
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.
Time Frame
Baseline to Week 8 and 12
Title
Change in dry mouth symptoms upon MEP participation as compared to the control group
Description
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.
Time Frame
Baseline to week 2, 4, 8 and 12
Title
Change in Oral Health-Related Quality of Life (OHRQoL) upon MEP participation, as compared to the control group
Description
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.
Time Frame
Week 4 to Week 8 and 12
Title
Change in clinical functioning upon MEP participation, as compared to the control group
Description
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.
Time Frame
Baseline to week 2, 4, 8 and 12
Title
Change in Global Perceived Effect by participants upon MEP participation, as compared to the control group
Description
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.
Time Frame
Baseline to week 2, 4, 8 and 12
Title
Change in Health Related Quality of Life (HRQoL) upon MEP participation, as compared to the control group
Description
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.
Time Frame
Baseline to week 2, 4, 8 and 12
Other Pre-specified Outcome Measures:
Title
Current clinical practices in dry mouth care as reported by health care professionals in both the control and intervention group (nurses and medical doctors)
Description
Current clinical practices for dry mouth care as reported by health care professionals are examined by a self-developed questionnaire, including questions (open-ended and multiple choice) on work experience and education and on all aspects of clinical practice for dry mouth care (such as initial identification of dry mouth symptoms, medical anamnesis, physical examination, interventions/treatment and monitoring, and use of guidelines). The questionnaire will be administered to all participating nurses in the intervention and control group, and supplemented by at least one medical doctor per study site.
Time Frame
At baseline and upon full study completion per study site (expected after an average of 1 year)
Title
Current clinical practices in dry mouth care as experienced by participants in the control group
Description
Participants' experiences in the control group (receiving care as usual) with dry mouth care are examined by individual semi-structured interviews.
Time Frame
Week 12
Title
Barriers and facilitators of the MEP as perceived by nurses participating in the intervention group.
Description
Barriers and facilitators as perceived by nurses leading the MEP consultations are identified through a questionnaire, adapted from the validated Dutch Implementation of an Innovation questionnaire. This questionnaire includes personal, logistic, financial, educational and work environment barriers and facilitators.
Time Frame
Upon study completion, after an average of 1 year
Title
Barriers, facilitators and overall applicability of the MEP as a means to structurally implement the existing guidelines as perceived by nurses participating in the intervention group.
Description
The barriers, facilitators and overall applicability of the MEP as perceived by the nurses leading the MEP consultations is further explored in focus groups.
Time Frame
Upon study completion, after an average of 1 year
Title
Barriers and facilitators of the MEP as perceived by participants in the intervention group.
Description
Experiences with the MEP and received care, including barriers and facilitators, by participants in the intervention group are examined by individual semi-structured interviews.
Time Frame
Upon study completion, after an average of 1 year
Title
Barriers and facilitators of the current guidelines for dry mouth care in the Netherlands as perceived by nurses in both the intervention and control group.
Description
Barriers and facilitators of the current guidelines are examined in focus groups with nurses from either arm.
Time Frame
Upon study completion, after an average of 1 year
Title
Cost-effectiveness Analysis (CEA) of the MEP, as compared to the control group
Description
The CEA is based upon patient-reported medical costs as measured by the Institute for Medical Technology Assessment (iMTA) Medical Consumption Questionnaire (iMCQ). It encompasses use of medical and paramedical treatments or services, in- and outpatient care and use of medication. Here, the questionnaire consists of three main questions asking for the frequency of contact with dental services, the frequency of contact with health care professionals across different disciplines and the purchase of dry mouth treatment products (e.g. medication and other aids) in the last four weeks.
Time Frame
Week 0, 4, 8 and 12.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Annelot I van der Meulen, MSc
Phone
071-526 1916
Email
aivandermeulen@lumc.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yvette M van der Linden, Prof. dr.
Organizational Affiliation
Leiden University Medical Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Onze Lieve Vrouwe Gasthuis (OLVG)
City
Amsterdam
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Annelot I van der Meulen, MSc
Email
aivandermeulen@lumc.nl

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The full IPD sharing plan or data sharing agreement can be provided upon request, but is based on the FAIR data sharing principles.
IPD Sharing Time Frame
Only after completion of the total study and after publication by the original researchers, will data be made available.
IPD Sharing Access Criteria
Data will be made available upon reasonable request by other researchers and will be decided upon on a case by case basis by the original researchers. When shared, data will be solely anonymized.

Learn more about this trial

A Mouth Education Program for Dry Mouth

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