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

Oral Health Clinical Trial

— MundZaRR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04140929
• Other study ID #: 01VSF18021
• Status: Recruiting
• Phase: N/A
• Start date: October 31, 2019
• Est. completion date: April 30, 2024

Study information

• Verified date: November 2022
• Source: University Hospital Schleswig-Holstein
• Contact: Katrin Hertrampf, Prof. Dr.
• Phone: +49 43150026113
• Email: hertrampf[@]mkg.uni-kiel.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 618
• Est. completion date: April 30, 2024
• Est. primary completion date: July 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Oral Health
• Oral-health Associated Quality of Life

Intervention

Other:
• Oral Health Tool Box
Please see, description of the intervention group

Locations

Country	Name	City	State
Germany	University Hospital Schleswig-Holstein	Kiel

Sponsors (5)

Lead Sponsor	Collaborator
University Hospital Schleswig-Holstein	Charite University, Berlin, Germany, Jena University Hospital, Martin-Luther-Universität Halle-Wittenberg, University of Applied Sciences, Cologne, Germany

Country where clinical trial is conducted

Germany, 

Outcome

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