Clinical trial NCT04140929: Oral Health Improvement for Nursing Home Residents Through Delegated Remotivation and Reinstruction
Official title: Oral Health Improvement for Nursing Home Residents Through Delegated Remotivation and Reinstruction - a Cluster-randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oral Health
Oral-health Associated Quality of Life
Keywords: nursing homes
oral hygiene
quality of life
health services research
Lead sponsor: University Hospital Schleswig-Holstein
Sponsor class: OTHER
Collaborators: name: Jena University Hospital
name: Martin-Luther-Universität Halle-Wittenberg
name: University of Applied Sciences, Cologne, Germany
name: Charite University, Berlin, Germany
First posted: 2019-10-28
Enrollment: 358
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cluster-randomized controlled trial
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: General Oral Health Assessment Index (GOHAI)
timeFrame: 12 months
Secondary outcomes:
measure: Pain scale
timeFrame: 12 months
measure: European Group Quality of life-5 Dimenions-5 Levels (EQ-5D-5L)
timeFrame: 12 months
measure: Decayed-Missing-Filled-Teeth (DMFT)
timeFrame: 12 months
measure: Geriatric Debris Index (GDI-S)
timeFrame: 12 months
measure: Periodonal Sulcus Index (PSI)
timeFrame: 12 months
measure: Denture Hygiene Index
timeFrame: 12 months
measure: Health economic analysis
timeFrame: 12 months
Other outcomes:
Locations:
city: Kiel
country: Germany
facility: University Hospital Schleswig-Holstein
Study officials:
References:
citation: Hertrampf K, Schlattmann P, Meyer G, Gassmann G, Abraham J, Hammen V, Schwendicke F. Oral health improvement for nursing home residents through delegated remotivation and reinstruction (MundZaRR Study): study protocol of a cluster-randomised controlled trial. BMJ Open. 2020 Sep 25;10(9):e035999. doi: 10.1136/bmjopen-2019-035999.