Oral Health Improvement for Nursing Home Residents Through Delegated Remotivation and Reinstruction (MundZaRR)

November 2, 2022 updated by: Katrin Hertrampf, University Hospital Schleswig-Holstein

Oral Health Improvement for Nursing Home Residents Through Delegated Remotivation and Reinstruction - a Cluster-randomized Controlled Trial

Based on the poor situation of residents in German nursing homes with regard to oral health, a cluster-randomized Trial will be carried out in Rhineland-Palatindate, Germany. Dentists investigated residents to identify dental or oral hygiene problems. In the invention group, dentists' recommendations will be reinstructed to the nursing staff by dental assistance.

Study Overview

Status

Recruiting

Intervention / Treatment

Detailed Description

Introduction: Oral health and oral-health-associated quality-of-life (OHrQL) of residents in German nursing homes are poor. The investigators will develop an evidence-based catalogue of interventions applicable and sustainable ("Oral Health Tool Box"). Based on this, care-accompanying reinstruction and remotivation of nursing staff by dental assistants (DA) will be provided. The investigators hypothesize such complex intervention to significantly improve OHrQL, and daily oral hygiene/care behaviour and its cost-effectiveness.

Methods and analysis: Based on the findings of a rapid systematic review, possible intervention components will be systematized and assessed for their effectiveness. Mixed methods will be used to identify barriers and enablers of oral hygiene and care in German long-term residential care (LRC), and these will be linked with the intervention components using the Theoretical Domains Framework and the Behavior Change Wheel, the result being an "Oral Health Tool Box". A two-arm cluster, randomized-controlled-trial (ratio of 1:1 via block randomization) will be performed in nursing homes in Rhineland-Palatinate, Germany, including residents with moderate to severe care dependency. Each nursing home represents a cluster. Based on a feasibility study, considering clustering and possible attrition, the investigators aim at recruiting 618 residents of 18 cluster. In the intervention group, dentists will identify the specific problems of each resident, and assign one or more intervention components from the box. During follow-up, nursing staff will be reinstructed and remotivated by dental assistants in how to deliver the intervention components in individual intervals. In the control group residents will receive care as usual. The primary outcome, OHrQL, will be measured using the German version of the General Oral Health Assessment Index (GOHAI). Secondary outcomes include pain condition, general health-related quality-of-life, caries increment, oral/prothetic hygiene and gingival status, incidence of dental emergencies and hospitalizations, and cost-utility/effectiveness. The endpoints will be measured at baseline and after 12 months. For the primary outcome, a mixed-linear model will be used within an intention-to-treat analysis. A process evaluation using mixed methods will be conducted alongside the trial.

Due to the pandemic, the number of cases could not be reached despite outstanding commitment in recruitment. An application was made to the funding agency to adapt the project plan.

Study Type

Interventional

Enrollment (Anticipated)

618

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

      • Kiel, Germany
        • Recruiting
        • University Hospital Schleswig-Holstein
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Nursing homes without an existing dental cooperation agreement. Eligible are residents with a degree of care dependency of 3 to 5 (moderate to severe) as rated by an expert rater of the German statutory health insurance.

Exclusion Criteria:

  • lack of consent (of the home management and/or the residents or their proxies or legal guardians) and residents in respite carer

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Intervention group
In the intervention group, a range of clinical parameters are recorded and the dentists prepares an individual oral hygiene and care recommendation, based on the Oral Health Tool Box. The Box is also used for instructing the dental assistants and the nursing staff for each patient individually. It is then determined when and how the dental assistants re-evaluates the oral hygiene and care process and reinstructs and remotivates the nursing staff. If the examination reveals a need for dental treatment (possibly requiring referral and transport), this will be communicated to the nursing staff. The dental assistant will further receive a training in communication, enabling them in reinstruction and remotivation. Dentists and dental assistants will further receive a training in geriatric dentistry by the State Commissioner of the German Society for Geriatric Dentistry.
Please see, description of the intervention group
NO_INTERVENTION: Control group
In the control group, the residents receive care as usual. This includes the recording of the same parameters are recorded as in intervention group, a standardized form is filled out and handed over to the nursing staff. As in the case of Intervention group, the nursing staff is informed in the event of a need for treatment. No further measures are applied.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
General Oral Health Assessment Index (GOHAI)
Time Frame: 12 months
The GOHAI is an established instrument for measuring oral health-related quality of life (OHRQoL) in older people. It comprises twelve items in four domains (functional limitations, pain/discomfort, psychological aspects, behavioral aspects), which are recorded ordinally scaled from 0 (never true) to 5 (always true).
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain scale
Time Frame: 12 months
Measurement of actual pain by scale (1-10), 1 -least pain, 10-most pain
12 months
European Group Quality of life-5 Dimenions-5 Levels (EQ-5D-5L)
Time Frame: 12 months
Health-related quality of life
12 months
Decayed-Missing-Filled-Teeth (DMFT)
Time Frame: 12 months
Caries experience/tooth loss, measured with Decayed-Missing-Filled Teeth,and root caries lesions
12 months
Geriatric Debris Index (GDI-S)
Time Frame: 12 months
Oral hygiene status
12 months
Periodonal Sulcus Index (PSI)
Time Frame: 12 months
gingival inflammation
12 months
Denture Hygiene Index
Time Frame: 12 months
Prosthetic hygiene
12 months
Health economic analysis
Time Frame: 12 months
Incidence of dental-associated emergencies and hospitalisations. Nursing,dental and inpatient treatment costs
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 31, 2019

Primary Completion (ANTICIPATED)

July 31, 2023

Study Completion (ANTICIPATED)

April 30, 2024

Study Registration Dates

First Submitted

October 24, 2019

First Submitted That Met QC Criteria

October 24, 2019

First Posted (ACTUAL)

October 28, 2019

Study Record Updates

Last Update Posted (ACTUAL)

November 7, 2022

Last Update Submitted That Met QC Criteria

November 2, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • 01VSF18021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

After completion of the whole study, the results will be published

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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