Oral HealthGAPANCT06310798
Inter-organizational Health Planning for Older Adults: Public Dental Care and Municipal Care
A study testing Inter-professional team test in people with Oral Health and Oral Health Related Quality of Life, run by Vastra Gotaland Region at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Oral Health, Oral Health Related Quality of Life, Participation
- What is being tested?
- Inter-professional team test
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 1 siteSweden
- Study dates
- 1 Mar 2025to 1 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Enrolled within the Swedish dental remuneration program and enrolled within municipal care services.
Who cannot join
- Younger than 65 years.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Folktandvården Västra Götaland
Gothenburg, Västra Götalandsregionen, 42139
Jessica Persson Kylén, PhD, +46769472654, jessica.persson-kylen@hv.se
Eva-Karin Bergström, PhD, +46733261110, eva-karin.bergstrom@vgregion.se
About this study
Official title: Outcomes of Inter-organizational Health Planning Between Public Dental Care and Municipal Care Organizations for Older People: A Study Protocol for a Randomized Controlled Study in Sweden
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.
Read the detailed description
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.
The evaluation of the revised team-based model assisted by a digital platform is planned to be conducted as a randomized controlled trial (RCT) .
All participation within the RCT, both in terms of professionals and older adults, will be voluntary and the project will be ethically reviewed. In West Sweden, the public dental care organization (including 3200 dental care professionals) is responsible for performing all oral assessments within the dental care remuneration programme. This guarantees a large empirical base. In pairs, DHs within public dental care organizations in West Sweden will be randomized into test and control groups. Due to geographical concerns, NAs within the same municipality 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 to conduct oral assessments and health planning in home settings. The control group will consist of 12 DHs where each DH will perform oral assessments according to the dental care remuneration programme - that is, they will conduct business as usual on 15 older adults each. It is not mandatory but recommended for NAs to participate in the oral assessments; therefore, the number of participating NAs within the control group is unknown. In total, 360 oral assessments and health planning sessions will be performed within the RCT.
The test group will participate in a two-day course, where initially an informed consent will be signed by all participates, thereafter they will practise:
- Oral assessments according to Revised oral assessment guide.
- Oral hygiene ability assessments according to Oral Hygiene Ability Index.
- Oral health-related quality of life assessment with the Geriatric Oral Health Assessment Index.
- Shared decision-making according to Ottawa Decision Support Framework.
- Using the digital platform. The course will be both theoretical and practical with elements of reflection. Also, test group management within dental and municipal healthcare will participate in a common half-day course where they will learn about the intervention and the digital platform. A dialogue regarding obstacles and opportunities will facilitate a common understanding and the continued implementation process. They will also set common goals regarding how to support the intervention.
At baseline, two project coordinators (DHs) will collect informed consent from all participants, before the intervention. Thereafter empirical data will be collected. All older adults that participate will be enrolled in the dental care remuneration programme and in home care. Participants within the test and control groups will answer on the following parameters at baseline, which will guide the evaluation.
At baseline:
- Empirical data.
- Mini mental state examination (MMSE-SR).
- Revised oral assessment guide.
- Geriatric Oral Health Assessment Index.
Primary outcomes:
- Older adults' oral health status according to Revised oral assessment guide.
- Older adults self-perception of their oral health-related quality of life according to Geriatric Oral Health Assessment Index.
Secondary outcomes:
- Sure of myself; Understand information; Risk-benefit ratio; Encouragement - test before and after health planning in oral assessments. The Sure of myself; Understanding information; Risk-benefit ration; Encouragement-test is based on four validated questions which describe the older adults' uncertainty about which treatment to choose and aspects contributing to uncertainty about the benefits and risks of each option, what matters most to the older adults, support in making a choice and feeling sure about the best choice.
- Person-Centered care Assessment Tool to measure the professionals' experience of the extent to which the care is experienced as being person-centred.
- All participants' (DHs, NAs and older adults) will be measured by health-related quality of life.
- Oral hygiene ability index, for measuring ability to perform oral hygiene tasks. The oral hygiene ability index should be used when indicated, when Revised oral assessments guide shows 2 or 3 at the variables 'teeth', 'gum', 'saliva' and 'oral mucosa' or if the older adult expresses concerns about difficulties with maintaining oral hygiene.
All scales will be measured in both the test and control groups (relation 1:1). Thereafter, test (n=12) and control (n= 12) groups will conduct 15 oral assessments each in ordinary home settings. The DHs and NAs will individually rate their team performance level after each oral assessment from 1 to 10 (1 = very bad, 10 = excellent). Within the test group, options regarding dental care visits will be i) regular dental care visits, ii) digital consultation, iii) mobile unit at ordinary home settings and iv) doing nothing. Within the control group, the options regarding dental care visits will be 'business as usual', namely, i) regular dental care visits, ii) digital consultation or iii) doing nothing.
Follow-up at 6 months:
- Retrospective records review: Number of records including oral health aspects within municipal care. Number of older adults having established contact with dental care. Number of adults having been scheduled for dental treatment at mobile dental units and what treatment have been conducted.
- The oral health recommendations will be analysed compared to existing evidence-based guidelines and recommendations.
- Older adults' oral health status according to Revised oral assessment guide.
- Older adults' self-perception of oral health according to Geriatric oral health assessment index.
- All participants' (DHs, NAs and older adults) health-related quality of life.
Follow-up at 12 months:
- Oral health status according to Revised oral assessment guide.
- Older adults' self-perception of oral health according to Geriatric oral health assessment index.
- All participants' (DHs, NAs and older adults) health-related quality of life.
- Person-Centered care Assessment Tool. Data analysis Baseline characteristics will be presented as numbers (n). Comparisons between group between baseline and follow-up on primary outcomes (Revised oral assessment guide and Geriatric oral health assessment index) will be presented as means and mean changes, with 95 % confidence intervals (CI). Continuous variables will be analysed by t-test (unpaired for comparison between groups and paired for within group analyses). Comparisons between groups will be analysed using chi-square tests. The pre-chosen level of significance will be p < .05. The oral health risk assessment instrument revised oral assessment guide was used in the power calculation. Revised oral assessment index has a possible score of 2-27. Based on the assumption of a mean difference of 1 (SD 3) between the test and control groups, meaning that test group would improve and that the control group would worsen, the power was calculated to 0.8. According to the power calculation the number of older adults needed was 143 in the test- and control- groups, respectively. Given that the participants are frail older adults, an estimated dropout rate of approximately 25% needs to be taken into account, which means that 180 older adults are needed in the test and control groups respectively. The power-analysis has been conducted with assistance by a statistician (AM).
In parallel, research will be conducted to describe the development of the inter-professional and inter-organizational digital platform. Also, individual interviews are planned with professionals (DHs, NAs and managers), the dental team of the mobile unit (dentist and dental nurse) and older adults within the test and control groups. Further on, a health economic evaluation will be conducted.
- Conditions
- Oral Health, Oral Health Related Quality of Life, Participation, Participation, Patient, Health Planning
- Being tested
- Inter-professional team test
- Keywords
- health planning, Oral health, older adults, healthy ageing, patient participation, person-centered care
- Medical subject headings
- Patient Participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inter-professional team testBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Inter-professional team test | Experimental | Dental hygienists, nursing assistants and older adults participating in new model for oral health planning in ordinary home settings. Receives: 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: 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: 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: 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: 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: 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: Measured at 12 months after baseline
Secondary outcomes (3)
Sure of myself; understanding information; risk-benefit ration; encouragement-test
Validated instrument, screening for decisional conflicts during health planning, minimum rate 0; maximum rate 4. Low scores indicate high uncertainty regarding options. High scores indicates no decisional conflict.
Measured: Measured at baseline
Person centered care assessment tool
Validated instrument for assessing person centered care, minimum rate 13; maximum rate 65. Higher total score indicate a higher degree of person-centered care, while lower scores suggest areas for improvement.
Measured: Measured at baseline
Person centered care assessment tool
Validated instrument for assessing person centered care, minimum rate 13; maximum rate 65. Higher total score indicate a higher degree of person-centered care, while lower scores suggest areas for improvement.
Measured: Measured at 12 months after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start1 Mar 2025 (estimated)
- Primary completion15 May 2025 (estimated)
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Oral HealthStudies of the same condition, open and under way.
- More trials run by Vastra Gotaland RegionThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vastra Gotaland Region
- Sponsor type
- Other government
- Collaborators
- Göteborg University, Gothia Forum - Center for Clinical Trial, Chalmers University of Technology
- Responsible party
- Sponsor
- Investigators
- Åsa Leonardt, PhD, Principal investigator, Folktandvården Västra Götaland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06310798
- Sponsor's protocol ID
- Dnr. 2020-04603
- Acronym
- GAPA
- Status last verified
- Feb 2024
- First submitted
- 5 Mar 2024
- Last updated
- 15 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected individual participant data that underlie results in a publication may be shared, if it is possible due to General data protection regulation.
Publications
Persson Kylen J, Bjorns S, Adolfsson A, Lindmark U, Hagglin C, Almstahl A, Imberg H, Lundegard M, Torstensson S, Soder E, Karlen K, Baar AC, Persson Kylen S, Bogren A, Fjallman C, Klinge B, Wijk H. Protocol for the GAPA person-centred dental care at home intervention: a substudy within a cluster randomised controlled trial in Swedish home care. BMC Oral Health. 2026 Nov 3;26(1):2173. doi: 10.1186/s12903-026-10340-3.
PubMed 42977920Persson 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.
PubMed 39966931
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Inter-organizational Health Planning Between Public Dental Care and Municipal Care Organizations for Older People: A Study Protocol for a Randomized Controlled Study in Sweden
- ClinicalTrials.gov ID
- NCT06310798
- Acronym / sponsor ID
- GAPA / Dnr. 2020-04603
- Conditions
- Oral Health, Oral Health Related Quality of Life, Participation, Participation, Patient, Health Planning
- Keywords
- health planning, Oral health, older adults, healthy ageing, patient participation, person-centered care
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Vastra Gotaland RegionOther government
- Collaborators
- Göteborg University, Gothia Forum - Center for Clinical Trial, Chalmers University of Technology
- Study start
- 1 Mar 2025 (estimated)
- Primary completion
- 15 May 2025 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 15 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
The evaluation of the revised team-based model assisted by a digital platform is planned to be conducted as a randomized controlled trial (RCT) .
All participation within the RCT, both in terms of professionals and older adults, will be voluntary and the project will be ethically reviewed. In West Sweden, the public dental care organization (including 3200 dental care professionals) is responsible for performing all oral assessments within the dental care remuneration programme. This guarantees a large empirical base. In pairs, DHs within public dental care organizations in West Sweden will be randomized into test and control groups. Due to geographical concerns, NAs within the same municipality 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 to conduct oral assessments and health planning in home settings. The control group will consist of 12 DHs where each DH will perform oral assessments according to the dental care remuneration programme - that is, they will conduct business as usual on 15 older adults each. It is not mandatory but recommended for NAs to participate in the oral assessments; therefore, the number of participating NAs within the control group is unknown. In total, 360 oral assessments and health planning sessions will be performed within the RCT.
The test group will participate in a two-day course, where initially an informed consent will be signed by all participates, thereafter they will practise:
- Oral assessments according to Revised oral assessment guide.
- Oral hygiene ability assessments according to Oral Hygiene Ability Index.
- Oral health-related quality of life assessment with the Geriatric Oral Health Assessment Index.
- Shared decision-making according to Ottawa Decision Support Framework.
- Using the digital platform. The course will be both theoretical and practical with elements of reflection. Also, test group management within dental and municipal healthcare will participate in a common half-day course where they will learn about the intervention and the digital platform. A dialogue regarding obstacles and opportunities will facilitate a common understanding and the continued implementation process. They will also set common goals regarding how to support the intervention.
At baseline, two project coordinators (DHs) will collect informed consent from all participants, before the intervention. Thereafter empirical data will be collected. All older adults that participate will be enrolled in the dental care remuneration programme and in home care. Participants within the test and control groups will answer on the following parameters at baseline, which will guide the evaluation.
At baseline:
- Empirical data.
- Mini mental state examination (MMSE-SR).
- Revised oral assessment guide.
- Geriatric Oral Health Assessment Index.
Primary outcomes:
- Older adults' oral health status according to Revised oral assessment guide.
- Older adults self-perception of their oral health-related quality of life according to Geriatric Oral Health Assessment Index.
Secondary outcomes:
- Sure of myself; Understand information; Risk-benefit ratio; Encouragement - test before and after health planning in oral assessments. The Sure of myself; Understanding information; Risk-benefit ration; Encouragement-test is based on four validated questions which describe the older adults' uncertainty about which treatment to choose and aspects contributing to uncertainty about the benefits and risks of each option, what matters most to the older adults, support in making a choice and feeling sure about the best choice.
- Person-Centered care Assessment Tool to measure the professionals' experience of the extent to which the care is experienced as being person-centred.
- All participants' (DHs, NAs and older adults) will be measured by health-related quality of life.
- Oral hygiene ability index, for measuring ability to perform oral hygiene tasks. The oral hygiene ability index should be used when indicated, when Revised oral assessments guide shows 2 or 3 at the variables 'teeth', 'gum', 'saliva' and 'oral mucosa' or if the older adult expresses concerns about difficulties with maintaining oral hygiene.
All scales will be measured in both the test and control groups (relation 1:1). Thereafter, test (n=12) and control (n= 12) groups will conduct 15 oral assessments each in ordinary home settings. The DHs and NAs will individually rate their team performance level after each oral assessment from 1 to 10 (1 = very bad, 10 = excellent). Within the test group, options regarding dental care visits will be i) regular dental care visits, ii) digital consultation, iii) mobile unit at ordinary home settings and iv) doing nothing. Within the control group, the options regarding dental care visits will be 'business as usual', namely, i) regular dental care visits, ii) digital consultation or iii) doing nothing.
Follow-up at 6 months:
- Retrospective records review: Number of records including oral health aspects within municipal care. Number of older adults having established contact with dental care. Number of adults having been scheduled for dental treatment at mobile dental units and what treatment have been conducted.
- The oral health recommendations will be analysed compared to existing evidence-based guidelines and recommendations.
- Older adults' oral health status according to Revised oral assessment guide.
- Older adults' self-perception of oral health according to Geriatric oral health assessment index.
- All participants' (DHs, NAs and older adults) health-related quality of life.
Follow-up at 12 months:
- Oral health status according to Revised oral assessment guide.
- Older adults' self-perception of oral health according to Geriatric oral health assessment index.
- All participants' (DHs, NAs and older adults) health-related quality of life.
- Person-Centered care Assessment Tool. Data analysis Baseline characteristics will be presented as numbers (n). Comparisons between group between baseline and follow-up on primary outcomes (Revised oral assessment guide and Geriatric oral health assessment index) will be presented as means and mean changes, with 95 % confidence intervals (CI). Continuous variables will be analysed by t-test (unpaired for comparison between groups and paired for within group analyses). Comparisons between groups will be analysed using chi-square tests. The pre-chosen level of significance will be p < .05. The oral health risk assessment instrument revised oral assessment guide was used in the power calculation. Revised oral assessment index has a possible score of 2-27. Based on the assumption of a mean difference of 1 (SD 3) between the test and control groups, meaning that test group would improve and that the control group would worsen, the power was calculated to 0.8. According to the power calculation the number of older adults needed was 143 in the test- and control- groups, respectively. Given that the participants are frail older adults, an estimated dropout rate of approximately 25% needs to be taken into account, which means that 180 older adults are needed in the test and control groups respectively. The power-analysis has been conducted with assistance by a statistician (AM).
In parallel, research will be conducted to describe the development of the inter-professional and inter-organizational digital platform. Also, individual interviews are planned with professionals (DHs, NAs and managers), the dental team of the mobile unit (dentist and dental nurse) and older adults within the test and control groups. Further on, a health economic evaluation will be conducted.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Inter-professional team test | Experimental | Behavioral: Inter-professional team testDental hygienists, nursing assistants and older adults participating in new model for oral health planning in ordinary home settings. |
| 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). |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Enrolled within the Swedish dental remuneration program and enrolled within municipal care services.
Key exclusion criteria (1 listed)
- Younger than 65 years.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inter-professional team testDigital 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. | Behavioural | Inter-professional team test |
Primary outcome
Revised oral assessment guide
Time frame: Measured at baseline
Validated instrument for oral health assessments including nine items. Lowest rate: 2 - indicating healthy condition, maximum rate 27 indicating poor oral health.
Revised oral assessment guide
Time frame: Measured at 6 months after baseline
Validated instrument for oral health assessments including nine items. Lowest rate: 2 - indicating healthy condition, maximum rate 27 indicating poor oral health.
Revised oral assessment guide
Time frame: Measured at 12 months after baseline
Validated instrument for oral health assessments including nine items. Lowest rate: 2 - indicating healthy condition, maximum rate 27 indicating poor oral health.
Geriatric oral health assessment index
Time frame: Measured at baseline
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.
Geriatric oral health assessment index
Time frame: Measured at 6 months after baseline
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.
Geriatric oral health assessment index
Time frame: Measured at 12 months after baseline
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.
3 secondary outcomes
Sure of myself; understanding information; risk-benefit ration; encouragement-test
Time frame: Measured at baseline
Person centered care assessment tool
Time frame: Measured at baseline
Person centered care assessment tool
Time frame: Measured at 12 months after baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
- Derived from this study: PubMed 42977920Persson Kylen J, Bjorns S, Adolfsson A, Lindmark U, Hagglin C, Almstahl A, Imberg H, Lundegard M, Torstensson S, Soder E, Karlen K, Baar AC, Persson Kylen S, Bogren A, Fjallman C, Klinge B, Wijk H. Protocol for the GAPA person-centred dental care at home intervention: a substudy within a cluster randomised controlled trial in Swedish home care. BMC Oral Health. 2026 Nov 3;26(1):2173. doi: 10.1186/s12903-026-10340-3.
- Derived from this study: PubMed 39966931Persson 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.
- Individual participant dataSharing planned: Yes. All collected individual participant data that underlie results in a publication may be shared, if it is possible due to General data protection regulation.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Åsa Leonardt, PhD principal investigator
Folktandvården Västra Götaland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inter-professional team test in people with Oral Health and Oral Health Related Quality of Life, run by Vastra Gotaland Region at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jessica Persson Kylén, PhD-student (+46769472654, jessica.persson-kylen@hv.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Revised oral assessment guide (time frame: Measured at baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06310798, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2024.