Oral Health Clinical Trial
— GAPAOfficial 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.
Status | Not yet recruiting |
Enrollment | 360 |
Est. completion date | March 1, 2026 |
Est. primary completion date | May 15, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 65 Years and older |
Eligibility | Inclusion Criteria: - Enrolled within the Swedish dental remuneration program and enrolled within municipal care services. Exclusion Criteria: - Younger than 65 years. |
Country | Name | City | State |
---|---|---|---|
Sweden | Folktandvården Västra Götaland | Göteborg | Västra Götalandsregionen |
Lead Sponsor | Collaborator |
---|---|
Vastra Gotaland Region | Chalmers University of Technology, Göteborg University, Gothia Forum - Center for Clinical Trial |
Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Retrospective review of records within municipal health care | Number of records including oral health aspects within municipal care. Number of older adults having established contact with dental care. - The oral health recommendations will be analyzed compared to existing evidence-based guidelines and recommendations | Measured at 6 months after baseline | |
Other | Participants experiences of oral health planning in ordinary home settings | Individual interviews | Measured 3 months after baseline. | |
Other | Oral hygiene ability index (OHAI) | Validated instrument for oral hygiene ability. The scoring system uses scales from 0 to 4 for each oral hygiene task. Once the individualĀ“s performance on each oral hygiene task is assessed and scored, the total score is calculated by adding up the scores for all tasks. Higher scores generally indicate better oral hygiene ability, while lower scores may suggest limitations or difficulties in performing oral hygiene tasks effectively. | Measured at baseline | |
Other | Oral hygiene ability index (OHAI) | Validated instrument for oral hygiene ability. The scoring system uses scales from 0 to 4 for each oral hygiene task. Once the individualĀ“s performance on each oral hygiene task is assessed and scored, the total score is calculated by adding up the scores for all tasks. Higher scores generally indicate better oral hygiene ability, while lower scores may suggest limitations or difficulties in performing oral hygiene tasks effectively. | Measured at 12 months after baseline | |
Other | Health related quality of life instrument | Health related quality of life instrument. Scoring involves two steps, participants rate their health status in five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. For each dimension, respondents select one level of severity that best describes their health state on the day of the assessment. The levels are from 1 - 5, where 1 = no problems, 5 = Extreme problems. The chosen levels for each dimension are combined to form a health state profile, represented by a five-digit code. For example, a health state profile might be "21114" indicating slight problems in mobility and self-care, moderate problems in usual activities and pain/discomfort, and severe problems in anxiety/depression. | Measured at baseline | |
Other | Health related quality of life instrument | Health related quality of life instrument. Scoring involves two steps, participants rate their health status in five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. For each dimension, respondents select one level of severity that best describes their health state on the day of the assessment. The levels are from 1 - 5, where 1 = no problems, 5 = Extreme problems. The chosen levels for each dimension are combined to form a health state profile, represented by a five-digit code. For example, a health state profile might be "21114" indicating slight problems in mobility and self-care, moderate problems in usual activities and pain/discomfort, and severe problems in anxiety/depression. | Measured at 6 months after baseline | |
Other | Health related quality of life instrument | Health related quality of life instrument. Scoring involves two steps, participants rate their health status in five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. For each dimension, respondents select one level of severity that best describes their health state on the day of the assessment. The levels are from 1 - 5, where 1 = no problems, 5 = Extreme problems. The chosen levels for each dimension are combined to form a health state profile, represented by a five-digit code. For example, a health state profile might be "21114" indicating slight problems in mobility and self-care, moderate problems in usual activities and pain/discomfort, and severe problems in anxiety/depression. | Measured at 12 months after baseline | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | 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 at baseline | |
Secondary | 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 at baseline | |
Secondary | 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 at 12 months after baseline |
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