Trial Outcomes & Findings for Functionally-tailored Oral Care Intervention for Community-dwelling Older Adults With Dementia and Their Caregivers (NCT NCT04238520)

Last Updated: 2025-04-25

Results Overview

We used the Debris Index (DI) of the Oral Hygiene Index (a scale of 0 to 3, with lower values indicating no debris present and higher values indicating more soft debris on the tooth. Also called plaque score) to assess PWD's oral hygiene status. We used the percentage change in plaque scores between baseline and 3 months to evaluate the effectiveness of the proposed intervention on improving PWD's oral hygiene.

Recruitment status

COMPLETED

Study phase

Target enrollment

26 participants

Primary outcome timeframe

Baseline and 3 Months

Results posted on

2025-04-25

Participant Flow

Participant milestones

Participant milestones
Measure	Control PWD/CG dyads Control Intervention: Participants will receive a home-based, un-tailored oral care training. The training includes a tooth brushing and dental care demonstration, and information about oral diseases and dry mouth. This training will be 15 minutes in duration. Participants will have the opportunity to participate in the functionally tailored intervention following the end of this study.	Interventional PWD/CG dyads Functionally Tailored Oral Care Intervention: Participants receive a 4-week, hands-on, functionally-tailored intervention. The intervention will address topics including tooth brushing, denture care, inter-dental care, tongue care, and dry mouth care. There will be four sessions in total, with each intervention session lasting approximately 45 minutes.
Overall Study STARTED	7	19
Overall Study COMPLETED	5	13
Overall Study NOT COMPLETED	2	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Control PWD/CG dyads Control Intervention: Participants will receive a home-based, un-tailored oral care training. The training includes a tooth brushing and dental care demonstration, and information about oral diseases and dry mouth. This training will be 15 minutes in duration. Participants will have the opportunity to participate in the functionally tailored intervention following the end of this study.	Interventional PWD/CG dyads Functionally Tailored Oral Care Intervention: Participants receive a 4-week, hands-on, functionally-tailored intervention. The intervention will address topics including tooth brushing, denture care, inter-dental care, tongue care, and dry mouth care. There will be four sessions in total, with each intervention session lasting approximately 45 minutes.
Overall Study Withdrawal by Subject	1	1
Overall Study Lost to Follow-up	1	2
Overall Study Death	0	2
Overall Study Unsafe home environment for research staff	0	1

Baseline Characteristics

The overall numbers of baseline participants include 7 PWD and 7 FCG (total=14) in the control group and 19 PWD and 19 FCG (total=38). However, we analyzed PWD and FCG separately. So each row included 7 participant (7 for PWD and 7 for FCG).

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: Baseline and 3 Months

Population: The percentage change in plaque scores between baseline and 3 months was compared between the PWD in the control group and PWD in the study group. 26 PWD (7 in the control and 19 in the study group) with completed data at the baseline. A total of 18 PWD (control group=5 and study group=13) completed the study with data on this outcome measure.

Outcome measures

Outcome measures
Measure	Control - PWD n=7 Participants Control Intervention: Participants will receive a home-based, un-tailored oral care training. The training includes a tooth brushing and dental care demonstration, and information about oral diseases and dry mouth. This training will be 15 minutes in duration. Participants will have the opportunity to participate in the functionally tailored intervention following the end of this study.	Interventional - PWD n=19 Participants Study Group Intervention: Participants receive a 4-week, hands-on, functionally-tailored intervention. The intervention will address topics including tooth brushing, denture care, inter-dental care, tongue care, and dry mouth care. There will be four sessions in total, with each intervention session lasting approximately 45 minutes.
Person With Dementia: Oral Hygiene	29.6 percentage change in plaque scores Standard Deviation 32.9	37.3 percentage change in plaque scores Standard Deviation 23.4

PRIMARY outcome

Timeframe: Baseline and 3 Months

Population: The percentage change in Self-perceived Oral Care-giving Efficacy scores between baseline and 3 months was compared between the control and study groups. 26 FCG with complete data were included in the baseline analysis. A total of 18 completed the study with data on this outcome measure

Self-perceived Oral Care-giving Efficacy scale included 19 items to assess self-perceived efficacy in providing oral care to care recipients. We assessed CG's self-perceived oral care-giving efficacy at the baseline and 3-month follow-up visit. We used the percentage change in Self-perceived Oral Care-giving Efficacy scores between the baseline and 3-month follow-up to examine the effectiveness of the proposed intervention on improving CG's oral care-giving skills. Higher scores indicate a better improvement in self-perceived efficacy.

Outcome measures

Outcome measures
Measure	Control - PWD n=7 Participants Control Intervention: Participants will receive a home-based, un-tailored oral care training. The training includes a tooth brushing and dental care demonstration, and information about oral diseases and dry mouth. This training will be 15 minutes in duration. Participants will have the opportunity to participate in the functionally tailored intervention following the end of this study.	Interventional - PWD n=19 Participants Study Group Intervention: Participants receive a 4-week, hands-on, functionally-tailored intervention. The intervention will address topics including tooth brushing, denture care, inter-dental care, tongue care, and dry mouth care. There will be four sessions in total, with each intervention session lasting approximately 45 minutes.
Self-perceived Oral Care-giving Efficacy	12.6 percentage change in Self-perceived Oral Standard Deviation 8.3	17.5 percentage change in Self-perceived Oral Standard Deviation 24.8

SECONDARY outcome

Timeframe: Baseline and 3 Months

Population: The percentage change in dyadic relationship scores between baseline and 3 months was compared between the control and study groups. 12 dyads with missing data at the baseline were eliminated from the analysis. A total of 8 dyads completed the study with data on this outcome measure

Dyadic Relationship Scale (DRS) to measure strain between the caregiver and recipient within the past month on a scale of 1 to 4. The original DRS 11 items will be used for caregivers and 10 items will be used for care recipients. High scores indicate high levels of strain and positive interaction. We used the percentage change in dyadic relationship scores between the baseline and 3 months to examine how this intervention affected PWD/CG relationships.

Outcome measures

Outcome measures
Measure	Control - PWD n=4 Participants Control Intervention: Participants will receive a home-based, un-tailored oral care training. The training includes a tooth brushing and dental care demonstration, and information about oral diseases and dry mouth. This training will be 15 minutes in duration. Participants will have the opportunity to participate in the functionally tailored intervention following the end of this study.	Interventional - PWD n=11 Participants Study Group Intervention: Participants receive a 4-week, hands-on, functionally-tailored intervention. The intervention will address topics including tooth brushing, denture care, inter-dental care, tongue care, and dry mouth care. There will be four sessions in total, with each intervention session lasting approximately 45 minutes.
Dyadic Relationship	-10.7 percentage change in dyadic relationship Standard Deviation 20.3	14.1 percentage change in dyadic relationship Standard Deviation 27.1

Adverse Events

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Interventional

Serious events: 0 serious events

Other events: 0 other events

Deaths: 2 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Xi Chen, Associate Professor

The Ohio State University

Phone: 614-2920474

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Control n=14 Participants PWD/CG dyads Control Intervention: Participants will receive a home-based, un-tailored oral care training. The training includes a tooth brushing and dental care demonstration, and information about oral diseases and dry mouth. This training will be 15 minutes in duration. Participants will have the opportunity to participate in the functionally tailored intervention following the end of this study.	Interventional n=38 Participants PWD/CG dyads Functionally Tailored Oral Care Intervention: Participants receive a 4-week, hands-on, functionally-tailored intervention. The intervention will address topics including tooth brushing, denture care, inter-dental care, tongue care, and dry mouth care. There will be four sessions in total, with each intervention session lasting approximately 45 minutes.	Total n=52 Participants Total of all reporting groups
Age, Continuous Participants with dementia	70.7 year STANDARD_DEVIATION 15.1 • n=7 Participants • The overall numbers of baseline participants include 7 PWD and 7 FCG (total=14) in the control group and 19 PWD and 19 FCG (total=38). However, we analyzed PWD and FCG separately. So each row included 7 participant (7 for PWD and 7 for FCG).	69.7 year STANDARD_DEVIATION 17.8 • n=19 Participants • The overall numbers of baseline participants include 7 PWD and 7 FCG (total=14) in the control group and 19 PWD and 19 FCG (total=38). However, we analyzed PWD and FCG separately. So each row included 7 participant (7 for PWD and 7 for FCG).	69.9 year STANDARD_DEVIATION 16.8 • n=26 Participants • The overall numbers of baseline participants include 7 PWD and 7 FCG (total=14) in the control group and 19 PWD and 19 FCG (total=38). However, we analyzed PWD and FCG separately. So each row included 7 participant (7 for PWD and 7 for FCG).
Age, Continuous Family caregiver	68.0 year STANDARD_DEVIATION 21.2 • n=7 Participants • The overall numbers of baseline participants include 7 PWD and 7 FCG (total=14) in the control group and 19 PWD and 19 FCG (total=38). However, we analyzed PWD and FCG separately. So each row included 7 participant (7 for PWD and 7 for FCG).	68.0 year STANDARD_DEVIATION 10.3 • n=19 Participants • The overall numbers of baseline participants include 7 PWD and 7 FCG (total=14) in the control group and 19 PWD and 19 FCG (total=38). However, we analyzed PWD and FCG separately. So each row included 7 participant (7 for PWD and 7 for FCG).	68.0 year STANDARD_DEVIATION 13.5 • n=26 Participants • The overall numbers of baseline participants include 7 PWD and 7 FCG (total=14) in the control group and 19 PWD and 19 FCG (total=38). However, we analyzed PWD and FCG separately. So each row included 7 participant (7 for PWD and 7 for FCG).
Sex: Female, Male Participants with dementia · Female	4 Participants n=7 Participants • 26 PWD/CG dyads (total=52 individuals) were included in the analysis. We reported PWD's and CG's characteristics separately.	12 Participants n=19 Participants • 26 PWD/CG dyads (total=52 individuals) were included in the analysis. We reported PWD's and CG's characteristics separately.	16 Participants n=26 Participants • 26 PWD/CG dyads (total=52 individuals) were included in the analysis. We reported PWD's and CG's characteristics separately.
Sex: Female, Male Participants with dementia · Male	3 Participants n=7 Participants • 26 PWD/CG dyads (total=52 individuals) were included in the analysis. We reported PWD's and CG's characteristics separately.	7 Participants n=19 Participants • 26 PWD/CG dyads (total=52 individuals) were included in the analysis. We reported PWD's and CG's characteristics separately.	10 Participants n=26 Participants • 26 PWD/CG dyads (total=52 individuals) were included in the analysis. We reported PWD's and CG's characteristics separately.
Sex: Female, Male Family caregivers · Female	4 Participants n=7 Participants • 26 PWD/CG dyads (total=52 individuals) were included in the analysis. We reported PWD's and CG's characteristics separately.	12 Participants n=19 Participants • 26 PWD/CG dyads (total=52 individuals) were included in the analysis. We reported PWD's and CG's characteristics separately.	16 Participants n=26 Participants • 26 PWD/CG dyads (total=52 individuals) were included in the analysis. We reported PWD's and CG's characteristics separately.
Sex: Female, Male Family caregivers · Male	3 Participants n=7 Participants • 26 PWD/CG dyads (total=52 individuals) were included in the analysis. We reported PWD's and CG's characteristics separately.	7 Participants n=19 Participants • 26 PWD/CG dyads (total=52 individuals) were included in the analysis. We reported PWD's and CG's characteristics separately.	10 Participants n=26 Participants • 26 PWD/CG dyads (total=52 individuals) were included in the analysis. We reported PWD's and CG's characteristics separately.
Race (NIH/OMB) PWD · American Indian or Alaska Native	0 Participants n=7 Participants • 26 PWD/CG dyads (total=52 individuals) were included in the analysis. We reported their characteristics separately.	0 Participants n=19 Participants • 26 PWD/CG dyads (total=52 individuals) were included in the analysis. We reported their characteristics separately.	0 Participants n=26 Participants • 26 PWD/CG dyads (total=52 individuals) were included in the analysis. We reported their characteristics separately.
Race (NIH/OMB) PWD · Asian	0 Participants n=7 Participants • 26 PWD/CG dyads (total=52 individuals) were included in the analysis. We reported their characteristics separately.	0 Participants n=19 Participants • 26 PWD/CG dyads (total=52 individuals) were included in the analysis. We reported their characteristics separately.	0 Participants n=26 Participants • 26 PWD/CG dyads (total=52 individuals) were included in the analysis. We reported their characteristics separately.
Race (NIH/OMB) PWD · Native Hawaiian or Other Pacific Islander	0 Participants n=7 Participants • 26 PWD/CG dyads (total=52 individuals) were included in the analysis. We reported their characteristics separately.	0 Participants n=19 Participants • 26 PWD/CG dyads (total=52 individuals) were included in the analysis. We reported their characteristics separately.	0 Participants n=26 Participants • 26 PWD/CG dyads (total=52 individuals) were included in the analysis. We reported their characteristics separately.
Race (NIH/OMB) PWD · Black or African American	0 Participants n=7 Participants • 26 PWD/CG dyads (total=52 individuals) were included in the analysis. We reported their characteristics separately.	2 Participants n=19 Participants • 26 PWD/CG dyads (total=52 individuals) were included in the analysis. We reported their characteristics separately.	2 Participants n=26 Participants • 26 PWD/CG dyads (total=52 individuals) were included in the analysis. We reported their characteristics separately.
Race (NIH/OMB) PWD · White	7 Participants n=7 Participants • 26 PWD/CG dyads (total=52 individuals) were included in the analysis. We reported their characteristics separately.	16 Participants n=19 Participants • 26 PWD/CG dyads (total=52 individuals) were included in the analysis. We reported their characteristics separately.	23 Participants n=26 Participants • 26 PWD/CG dyads (total=52 individuals) were included in the analysis. We reported their characteristics separately.
Race (NIH/OMB) PWD · More than one race	0 Participants n=7 Participants • 26 PWD/CG dyads (total=52 individuals) were included in the analysis. We reported their characteristics separately.	0 Participants n=19 Participants • 26 PWD/CG dyads (total=52 individuals) were included in the analysis. We reported their characteristics separately.	0 Participants n=26 Participants • 26 PWD/CG dyads (total=52 individuals) were included in the analysis. We reported their characteristics separately.
Race (NIH/OMB) PWD · Unknown or Not Reported	0 Participants n=7 Participants • 26 PWD/CG dyads (total=52 individuals) were included in the analysis. We reported their characteristics separately.	1 Participants n=19 Participants • 26 PWD/CG dyads (total=52 individuals) were included in the analysis. We reported their characteristics separately.	1 Participants n=26 Participants • 26 PWD/CG dyads (total=52 individuals) were included in the analysis. We reported their characteristics separately.
Race (NIH/OMB) FCG · American Indian or Alaska Native	0 Participants n=7 Participants • 26 PWD/CG dyads (total=52 individuals) were included in the analysis. We reported their characteristics separately.	0 Participants n=19 Participants • 26 PWD/CG dyads (total=52 individuals) were included in the analysis. We reported their characteristics separately.	0 Participants n=26 Participants • 26 PWD/CG dyads (total=52 individuals) were included in the analysis. We reported their characteristics separately.
Race (NIH/OMB) FCG · Asian	0 Participants n=7 Participants • 26 PWD/CG dyads (total=52 individuals) were included in the analysis. We reported their characteristics separately.	0 Participants n=19 Participants • 26 PWD/CG dyads (total=52 individuals) were included in the analysis. We reported their characteristics separately.	0 Participants n=26 Participants • 26 PWD/CG dyads (total=52 individuals) were included in the analysis. We reported their characteristics separately.
Race (NIH/OMB) FCG · Native Hawaiian or Other Pacific Islander	0 Participants n=7 Participants • 26 PWD/CG dyads (total=52 individuals) were included in the analysis. We reported their characteristics separately.	0 Participants n=19 Participants • 26 PWD/CG dyads (total=52 individuals) were included in the analysis. We reported their characteristics separately.	0 Participants n=26 Participants • 26 PWD/CG dyads (total=52 individuals) were included in the analysis. We reported their characteristics separately.
Race (NIH/OMB) FCG · Black or African American	0 Participants n=7 Participants • 26 PWD/CG dyads (total=52 individuals) were included in the analysis. We reported their characteristics separately.	1 Participants n=19 Participants • 26 PWD/CG dyads (total=52 individuals) were included in the analysis. We reported their characteristics separately.	1 Participants n=26 Participants • 26 PWD/CG dyads (total=52 individuals) were included in the analysis. We reported their characteristics separately.
Race (NIH/OMB) FCG · White	7 Participants n=7 Participants • 26 PWD/CG dyads (total=52 individuals) were included in the analysis. We reported their characteristics separately.	17 Participants n=19 Participants • 26 PWD/CG dyads (total=52 individuals) were included in the analysis. We reported their characteristics separately.	24 Participants n=26 Participants • 26 PWD/CG dyads (total=52 individuals) were included in the analysis. We reported their characteristics separately.
Race (NIH/OMB) FCG · More than one race	0 Participants n=7 Participants • 26 PWD/CG dyads (total=52 individuals) were included in the analysis. We reported their characteristics separately.	0 Participants n=19 Participants • 26 PWD/CG dyads (total=52 individuals) were included in the analysis. We reported their characteristics separately.	0 Participants n=26 Participants • 26 PWD/CG dyads (total=52 individuals) were included in the analysis. We reported their characteristics separately.
Race (NIH/OMB) FCG · Unknown or Not Reported	0 Participants n=7 Participants • 26 PWD/CG dyads (total=52 individuals) were included in the analysis. We reported their characteristics separately.	1 Participants n=19 Participants • 26 PWD/CG dyads (total=52 individuals) were included in the analysis. We reported their characteristics separately.	1 Participants n=26 Participants • 26 PWD/CG dyads (total=52 individuals) were included in the analysis. We reported their characteristics separately.
Region of Enrollment United States	14 participants n=14 Participants	38 participants n=38 Participants	52 participants n=52 Participants