Trial Outcomes & Findings for Reducing Care-Resistant Behaviors During Oral Hygiene in Persons With Dementia (NCT NCT01363258)
NCT ID: NCT01363258
Last Updated: 2018-06-07
Results Overview
Care-resistant behavior will be measured using the Resistiveness to Care Scale.This instrument is a checklist. The 13 care-resistant behaviors (e.g., turn away, hit/kick, say "no", etc.) are listed on the left side of the instrument. There are 3 columns for each behavior (mild, moderate, and severe). When behaviors occur, a tick mark is placed in the appropriate column (mild, moderate, or severe). The final score is obtained by multiplying the sums for mild by 1, the sums for moderate by 2, and the sums for severe behavior by 3. These subtotals are then summed together for a final care-resistant behavior score. One cannot determine the frequency and quality of behaviors from raw scores alone. For example, a score of 12 could mean 12 "mild" behaviors or 4 "severe" behaviors. The sums were used as global care-resistant behavior. Higher numbers signify more frequent and intense care-resistant behavior. Minimum value was 0, max value was 25.
COMPLETED
NA
100 participants
Baseline (observation) to follow-up (week 3)
2018-06-07
Participant Flow
Recruitment occurred sequentially in 9 United States NHs.
Once potential participants were identified, we obtained consent from the legally authorized representative, screened them against inclusion/exclusion criteria, and then randomly assigned them to control or experimental groups.
Participant milestones
| Measure |
Control
Received twice daily standard mouth care for 21 days from research team members. Briefly, all tooth and tongue dorsum surfaces were brushed using a soft toothbrush and fluoride toothpaste. Interdental cleaning was accomplished using interdental brushes. After interdental cleaning, participants rinsed and spit using non-alcoholic antimicrobial (0.07% cetylpyridium chloride) mouth rinse.
|
Experimental
The Managing Oral Hygiene Using THreat Reduction (MOUTh) intervention contained 3 components: an evidence-based mouth care protocol for older adults with natural dentition and dentures \[all tooth and tongue dorsum surfaces were brushed using a soft toothbrush and fluoride toothpaste. Interdental cleaning was accomplished using interdental brushes. After interdental cleaning, participants rinsed and spit using non-alcoholic antimicrobial (0.07% cetylpyridium chloride) mouth rinse\] , recognition of CRBs, and strategies to reduce threat perception during the provision of mouth care.
|
|---|---|---|
|
Overall Study
STARTED
|
54
|
46
|
|
Overall Study
COMPLETED
|
54
|
46
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Reducing Care-Resistant Behaviors During Oral Hygiene in Persons With Dementia
Baseline characteristics by cohort
| Measure |
Control
n=54 Participants
Received twice daily standard mouth care for 21 days from research team members. Briefly, all tooth and tongue dorsum surfaces were brushed using a soft toothbrush and fluoride toothpaste. Interdental cleaning was accomplished using interdental brushes. After interdental cleaning, participants rinsed and spit using non-alcoholic antimicrobial (0.07% cetylpyridium chloride) mouth rinse.
|
Experimental
n=46 Participants
The Managing Oral Hygiene Using THreat Reduction (MOUTh) intervention contained 3 components: an evidence-based mouth care protocol for older adults with natural dentition and dentures \[all tooth and tongue dorsum surfaces were brushed using a soft toothbrush and fluoride toothpaste. Interdental cleaning was accomplished using interdental brushes. After interdental cleaning, participants rinsed and spit using non-alcoholic antimicrobial (0.07% cetylpyridium chloride) mouth rinse\] , recognition of CRBs, and strategies to reduce threat perception during the provision of mouth care.
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
80.48 years
STANDARD_DEVIATION 11.54 • n=5 Participants
|
82.80 years
STANDARD_DEVIATION 8.92 • n=7 Participants
|
81.55 years
STANDARD_DEVIATION 9.91 • n=5 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
54 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
100 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
46 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
84 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
54 participants
n=5 Participants
|
46 participants
n=7 Participants
|
100 participants
n=5 Participants
|
|
Months in nursing home
|
17.39 months
STANDARD_DEVIATION 15.99 • n=5 Participants
|
28.74 months
STANDARD_DEVIATION 29.16 • n=7 Participants
|
22.66 months
STANDARD_DEVIATION 23.63 • n=5 Participants
|
|
Global Deterioration Scale
|
5.69 units on a scale
STANDARD_DEVIATION 1.03 • n=5 Participants
|
5.73 units on a scale
STANDARD_DEVIATION 0.71 • n=7 Participants
|
5.71 units on a scale
STANDARD_DEVIATION 0.89 • n=5 Participants
|
|
Katz Index of ADLs
|
9.33 units on a scale
STANDARD_DEVIATION 2.67 • n=5 Participants
|
9.76 units on a scale
STANDARD_DEVIATION 3.63 • n=7 Participants
|
9.53 units on a scale
STANDARD_DEVIATION 3.16 • n=5 Participants
|
|
Charlson Comorbidity Index
|
2.40 units on a scale
STANDARD_DEVIATION 1.53 • n=5 Participants
|
2.60 units on a scale
STANDARD_DEVIATION 2.56 • n=7 Participants
|
2.50 units on a scale
STANDARD_DEVIATION 2.06 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline (observation) to follow-up (week 3)Population: One-hundred nine NH residents were enrolled; 101 were randomized, 100 contributed data for analyses, and 91 completed the 3-week intervention period.
Care-resistant behavior will be measured using the Resistiveness to Care Scale.This instrument is a checklist. The 13 care-resistant behaviors (e.g., turn away, hit/kick, say "no", etc.) are listed on the left side of the instrument. There are 3 columns for each behavior (mild, moderate, and severe). When behaviors occur, a tick mark is placed in the appropriate column (mild, moderate, or severe). The final score is obtained by multiplying the sums for mild by 1, the sums for moderate by 2, and the sums for severe behavior by 3. These subtotals are then summed together for a final care-resistant behavior score. One cannot determine the frequency and quality of behaviors from raw scores alone. For example, a score of 12 could mean 12 "mild" behaviors or 4 "severe" behaviors. The sums were used as global care-resistant behavior. Higher numbers signify more frequent and intense care-resistant behavior. Minimum value was 0, max value was 25.
Outcome measures
| Measure |
Control
n=54 Participants
Received twice daily standard mouth care for 21 days from research team members. Briefly, all tooth and tongue dorsum surfaces were brushed using a soft toothbrush and fluoride toothpaste. Interdental cleaning was accomplished using interdental brushes. After interdental cleaning, participants rinsed and spit using non-alcoholic antimicrobial (0.07% cetylpyridium chloride) mouth rinse.
|
Experimental
n=46 Participants
The Managing Oral Hygiene Using THreat Reduction (MOUTh) intervention contained 3 components: an evidence-based mouth care protocol for older adults with natural dentition and dentures \[all tooth and tongue dorsum surfaces were brushed using a soft toothbrush and fluoride toothpaste. Interdental cleaning was accomplished using interdental brushes. After interdental cleaning, participants rinsed and spit using non-alcoholic antimicrobial (0.07% cetylpyridium chloride) mouth rinse\] , recognition of CRBs, and strategies to reduce threat perception during the provision of mouth care.
|
|---|---|---|
|
Care-Resistant Behavior
Observation (Baseline)
|
4.84 units on a scale
Standard Error 0.66
|
6.3 units on a scale
Standard Error 0.86
|
|
Care-Resistant Behavior
Follow-up (Week 3)
|
4.42 units on a scale
Standard Error 0.48
|
4.91 units on a scale
Standard Error 0.53
|
SECONDARY outcome
Timeframe: Baseline (observation) to follow-up (week 3)The oral health will be measured as the total score obtained from the Oral Health Assessment Tool. The OHAT contains 8 categories (e.g., status of gums, dentition, moisture of oral cavity, general cleanliness, etc.). Each category is assigned a value of 0=healthy, 1=problematic, and 2=unhealthy. Scores range from 0 (healthy) to 16 (unhealthy).
Outcome measures
| Measure |
Control
n=54 Participants
Received twice daily standard mouth care for 21 days from research team members. Briefly, all tooth and tongue dorsum surfaces were brushed using a soft toothbrush and fluoride toothpaste. Interdental cleaning was accomplished using interdental brushes. After interdental cleaning, participants rinsed and spit using non-alcoholic antimicrobial (0.07% cetylpyridium chloride) mouth rinse.
|
Experimental
n=46 Participants
The Managing Oral Hygiene Using THreat Reduction (MOUTh) intervention contained 3 components: an evidence-based mouth care protocol for older adults with natural dentition and dentures \[all tooth and tongue dorsum surfaces were brushed using a soft toothbrush and fluoride toothpaste. Interdental cleaning was accomplished using interdental brushes. After interdental cleaning, participants rinsed and spit using non-alcoholic antimicrobial (0.07% cetylpyridium chloride) mouth rinse\] , recognition of CRBs, and strategies to reduce threat perception during the provision of mouth care.
|
|---|---|---|
|
Oral Health
Observation (Baseline)
|
4.93 units on a scale
Standard Error 0.68
|
4.86 units on a scale
Standard Error 0.68
|
|
Oral Health
Follow-up (Week 3)
|
3.83 units on a scale
Standard Error 0.62
|
3.42 units on a scale
Standard Error 0.61
|
Adverse Events
Control
Experimental
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place