NCT06536322

Brief Summary

BACKGROUND: Oral health of nursing home residents is often poor. Oral health is related to general health, quality of life and well-being. Health care providers in nursing homes can be seen as important intermediaries to improve oral health as they are responsible for the residents' daily care and as they could regularly check resident's oral health. The goal of this interventional study is to evaluate the use of a new oral health screening tool for older adults in nursing homes (OHS-interRAI) in an everyday context. This tool is included in the Belgian version of the International Resident Assessment Instrument for long-term care facilities and will be used by healthcare providers without a dental background. The evaluation will be done at different levels using mixed methods. The main questions this study aims to answer at level of the residents are:

  • What is the effect of regular oral health assessment on oral health of the residents?
  • How do residents perceive oral health and experience the regular oral health assessments? At level of the health care providers the main questions are:
  • How do they experience the use of the OHS-interRAI for oral health assessments?
  • To what extent are the assessments by health care providers comparable to assessments performed by oral health professionals? METHODS: This research will compare the outcomes of nursing homes using the OHS-interRAI with outcomes of nursing homes using the oral health screening tool which is currently used in Belgian nursing homes. Nursing homes will be assigned randomly to the different groups. Both healthcare providers and residents assign for participation. Healthcare providers will follow a training on how to perform the screening with the OHS-interRAI and to monitor residents' oral health. Residents agree to regular oral health assessments by their healthcare providers every six months over a 2-years period.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
462

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 3, 2022

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

July 23, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 2, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2025

Completed
Last Updated

August 2, 2024

Status Verified

July 1, 2024

Enrollment Period

3.2 years

First QC Date

July 23, 2024

Last Update Submit

July 30, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Oral health data measured with interRAI LTCF

    The oral health related data measured with interRAI LTCF consists of 6 items which are scored dichotomously. The optimized oral health-related section (OHS-interRAI) consists of 9 items and result in categorized data: 1= good condition, 2= bad condition, 3= not judgable, 4= not applicable. As only scores 1 and 2 distinguish between good and bad condition, the items can be seen as dichotomous variables. Oral health data is collected by healthcare providers and dentists.

    every six months over a 2-years period

Secondary Outcomes (5)

  • Oral Hygiene Index

    every six months over a 2-years period

  • Modified Gingival Index

    every six months over a 2-years period

  • PUFA-index - Pulp, Ulceration, Fistel, Abscess

    every six months over a 2-years period

  • Interview data

    interviews will be conducted within 14 to 80 days following the baseline oral health assessment

  • Oral Health Impact Profile (OHIP-14)

    will be assessed within 14 to 80 days following the baseline oral health assessment

Other Outcomes (1)

  • Qualitative data on the use of the OHS-interRAI for oral health assessments

    3 months after intervention and one year after intervention

Study Arms (3)

control group

NO INTERVENTION

Healthcare providers assess the oral health of the residents on a regular basis using the current oral health section of BelRAI LTCF and deliver (oral) care as usual.

intervention group T1

EXPERIMENTAL

Healthcare providers in intervention group T1 assess the oral health of the residents on a regular basis using the OHS-interRAI after completing an e-learning on how to perform the assessment.

Other: OHS-interRAI

Intervention group T2

EXPERIMENTAL

Healthcare providers in intervention group T2 have the same condition as intervention group T1. Additionally they received on-site practical training to perform the assessment and can ask for support throughout the project concerning all aspects of oral health assessment and oral care.

Other: OHS-interRAI

Interventions

An oral health screening tool is being tested. Former name was the optimized oral health-related section of the interRAI (ohr-interRAI). This was further optimized into the OHS-interRAI. The OHS-interRAI comprises of 3 oral health-related items that are assessed through questioning the resident, and 6 items that require visual inspection of the mouth.

Intervention group T2intervention group T1

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Residents need to be 65 years or older
  • Residents have permanent residence in a nursing home

You may not qualify if:

  • Residents with a palliative health situation, assessed using the interRAI LTCF, are excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

KU Leuven

Leuven, Belgium

Location

Related Publications (4)

  • Vandenbulcke PAI, de Almeida Mello J, Cornette V, Brabants M, Schoebrechts E, De Lepeleire J, Declercq A, Declerck D, Duyck J. Nursing home residents' perspectives on oral health: An in-depth interview study. Int J Nurs Stud Adv. 2024 Apr 11;6:100198. doi: 10.1016/j.ijnsa.2024.100198. eCollection 2024 Jun.

  • Vandenbulcke PAI, de Almeida Mello J, Schoebrechts E, De Lepeleire J, Declercq A, Declerck D, Duyck J. Screening oral health in older adults: accuracy of the Oral Health Screener for use within the interRAI. Sci Rep. 2026 Jan 26. doi: 10.1038/s41598-026-35517-2. Online ahead of print. No abstract available.

  • Vandenbulcke PAI, de Almeida Mello J, Piccart FMP, De Lepeleire J, Schoebrechts E, Declercq A, Declerck D, Duyck J. Implementation of the OHS-interRAI for regular oral health assessments by non-dental caregivers: focus group study using a SWOT analysis. BMC Public Health. 2025 Jul 26;25(1):2552. doi: 10.1186/s12889-025-22938-3.

  • Vandenbulcke PAI, de Almeida Mello J, Schoebrechts E, De Lepeleire J, Declercq A, Declerck D, Duyck J. Oral health of nursing home residents in Flanders, Belgium, and its associated factors. Sci Rep. 2025 Feb 14;15(1):5463. doi: 10.1038/s41598-025-89910-4.

MeSH Terms

Conditions

Alzheimer DiseaseMouth Diseases

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental DisordersStomatognathic Diseases

Study Officials

  • Joke Duyck

    KU Leuven

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Care providers and participants in the intervention group know they are testing a new tool. Care providers and participants in the control group continue care as usual and do not know about the new tool.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: cluster randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 23, 2024

First Posted

August 2, 2024

Study Start

January 3, 2022

Primary Completion

February 28, 2025

Study Completion

February 28, 2025

Last Updated

August 2, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

The oral health data that support the findings of this study are available from Pyxicare, Belgium, but restrictions apply to the availability of these data, which were used under General Data Protection Regulation (GDPR) license for the current study. Therefore, data are not publicly available, but can be assessed upon reasonable request and with permission from the Belgian Privacy Commission.

Locations