NCT06310798

Brief Summary

Patient participation is key for healthy ageing and essential in health planning and decision-making. Oral health is an important but sometimes neglected part of general health and there is little research on health planning in ordinary home settings where older adults, dental and nursing staff participate. It has been concluded that shared tools, such as common documentation, and working in teams enables person-centered care in ordinary home settings. Therefore, this protocol outlines the design of a randomized controlled trial (RCT) measuring and comparing effect of two models of team based oral health planning with a common tool (digital platform) in ordinary home care settings in Sweden. The overall aim of this project is to evaluate a person-centered inter-professional and inter-organizational model for oral health planning supported by a digital platform to enable healthy ageing. Following ethics approval, a study design was developed guided by the seven action-steps of the knowledge to action framework. In the sixth action-step, older adults within the existing dental care remuneration program in Sweden will serve as a base for the RCT. From there older adults,dental hygienists (DH) and nursing assistants (NA) will be randomized into test and control groups. The test group (n= 12 DH and 12 NA) will participate in a two-day course, where a three-step person-centered oral health model will be taught. Control group will be 12 DH within dental care remuneration program conducting business as usual (with unknown number of NA, due to present guidelines). In total 360 older adults/patients will be asked to participate. Test group and control group will respectively have 180 patients each, as such, each team (DH + NA) have 15 patients. Primary outcomes include diverse oral health aspects - the Revised Oral Assessment Guide and the Geriatric Oral Health Assessment Index. Secondary outcomes include a retrospective record review, a health economic evaluation, Person Centered care Assessment Tool and Oral Hygiene Ability Index. Additionally, qualitative studies from theoretical perspectives of change and learning based on interviews with key stakeholders will be conducted in both test and control group.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
360

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2025

Geographic Reach
1 country

1 active site

Status
not yet 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

First Submitted

Initial submission to the registry

March 5, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 15, 2024

Completed
12 months until next milestone

Study Start

First participant enrolled

March 1, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2025

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

March 15, 2024

Status Verified

February 1, 2024

Enrollment Period

3 months

First QC Date

March 5, 2024

Last Update Submit

March 13, 2024

Conditions

Keywords

health planningOral healtholder adultshealthy ageingpatient participationperson-centered care

Outcome Measures

Primary Outcomes (6)

  • Revised oral assessment guide

    Validated instrument for oral health assessments including nine items. Lowest rate: 2 - indicating healthy condition, maximum rate 27 indicating poor oral health.

    Measured at baseline

  • Revised oral assessment guide

    Validated instrument for oral health assessments including nine items. Lowest rate: 2 - indicating healthy condition, maximum rate 27 indicating poor oral health.

    Measured at 6 months after baseline

  • Revised oral assessment guide

    Validated instrument for oral health assessments including nine items. Lowest rate: 2 - indicating healthy condition, maximum rate 27 indicating poor oral health.

    Measured at 12 months after baseline

  • Geriatric oral health assessment index

    Validated instrument for oral health related quality of life including 12 items. Minimum rate 12, maximum rate 60. Higher scores indicate better oral health-related quality of life, while lower scores suggest poorer oral health-related quality of life.

    Measured at baseline

  • Geriatric oral health assessment index

    Validated instrument for oral health related quality of life including 12 items. Minimum rate 12, maximum rate 60. Higher scores indicate better oral health-related quality of life, while lower scores suggest poorer oral health-related quality of life.

    Measured at 6 months after baseline

  • Geriatric oral health assessment index

    Validated instrument for oral health related quality of life including 12 items. Minimum rate 12, maximum rate 60. Higher scores indicate better oral health-related quality of life, while lower scores suggest poorer oral health-related quality of life.

    Measured at 12 months after baseline

Secondary Outcomes (3)

  • Sure of myself; understanding information; risk-benefit ration; encouragement-test

    Measured at baseline

  • Person centered care assessment tool

    Measured at baseline

  • Person centered care assessment tool

    Measured at 12 months after baseline

Other Outcomes (7)

  • Retrospective review of records within municipal health care

    Measured at 6 months after baseline

  • Participants experiences of oral health planning in ordinary home settings

    Measured 3 months after baseline.

  • Oral hygiene ability index (OHAI)

    Measured at baseline

  • +4 more other outcomes

Study Arms (2)

Inter-professional team test

EXPERIMENTAL

Dental hygienists, nursing assistants and older adults participating in new model for oral health planning in ordinary home settings.

Behavioral: Inter-professional team test

Oral health planning control

NO INTERVENTION

Dental hygienists, nursing assistants and older adults participating in oral health planning in ordinary home settings (business as usual).

Interventions

Digital Platform Support is used to improve communication and collaboration between the different stakeholders involved in the care of older adults. This platform allows for the sharing of oral health assessments, plans, and recommendations, ensuring all parties have access to the same information and can contribute to the care planning process. Person-Centered, Three-Step Model: Initial oral health assessments conducted by dental professionals, A person-centered planning process where the needs and preferences of the older adults are prioritized, The implementation of tailored oral health care plans, emphasizing shared decision-making and the active involvement of older adults in their care. Educational Component: An important element of the intervention is the provision of a two-day course for nursing and dental staff.

Inter-professional team test

Eligibility Criteria

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

You may qualify if:

  • Enrolled within the Swedish dental remuneration program and enrolled within municipal care services.

You may not qualify if:

  • Younger than 65 years.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Folktandvården Västra Götaland

Gothenburg, Västra Götalandsregionen, 42139, Sweden

Location

Related Publications (1)

  • Persson Kylen J, Bjorns S, Hagglin C, Bellander L, Brattback Atzori A, Persson Kylen S, Baar AC, Wijk H. Evaluation of collaborative oral health care planning between older adults and personnel from public dental care and municipal care organizations: a study protocol for a cluster-randomized controlled study in Sweden. Trials. 2025 Feb 18;26(1):57. doi: 10.1186/s13063-025-08753-6.

MeSH Terms

Conditions

Patient Participation

Condition Hierarchy (Ancestors)

Patient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Åsa Leonardt, PhD

    Folktandvården Västra Götaland

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jessica Persson Kylén, PhD-student

CONTACT

Catharina Hägglin, Assoc. Prof

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: In pairs, DHs within public dental care organization in the West of Sweden will be randomized into test and control groups. Due to geographical concerns, NAs within the same municipal as the test control DHs will be asked to participate. As such, the test-group will consist of 12 DHs and 12 NAs. They will form teams in pairs, and each team will collaborate with 15 older adults each in home settings, who participate in the oral assessments and health planning. The control group will consist of 12 DHs which will perform oral assessments according to dental care remuneration programme - business as usual. It is not mandatory but recommended for NAs to participate in the oral assessments, therefore the number of participating NAs within control group is unknown. In total 360 oral assessments and health planning will be performed within the RCT.
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 5, 2024

First Posted

March 15, 2024

Study Start

March 1, 2025

Primary Completion

May 15, 2025

Study Completion

March 1, 2026

Last Updated

March 15, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will share

All collected individual participant data that underlie results in a publication may be shared, if it is possible due to General data protection regulation.

Shared Documents
STUDY PROTOCOL, ICF
Time Frame
This information will be available in November 2024.
Access Criteria
All researchers within the project will be able to access the data. The study protocol will be submitted to Trials. The informed consent form will be tested at ethical committee.
More information

Locations