Trial Outcomes & Findings for Testing Preliminary Effectiveness of a Training to Support CHWs Outreach on Dental to African American Caregivers (NCT NCT05511935)

NCT ID: NCT05511935

Last Updated: 2024-11-07

Results Overview

We asked participants 12 multiple choice knowledge questions related to oral health which we averaged to create a composite knowledge score for each participant ranging from 0 to 100. A score of 0 meant a participant got zero questions correct while a score of 100 meant a participant got all questions correct. We averaged these composite scores across all participants for both groups to create mean scores ranging from 0 to 100, the higher the score the more questions participants answered correctly.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

143 participants

Primary outcome timeframe

Baseline

Results posted on

2024-11-07

Participant Flow

Recruited participants from AHECS in MD, PA, TX, and the National Association of Community Health Workers.

Participant milestones

Participant milestones
Measure
Exposed to GRIN Training
participates in the intervention professional development training for CHWs on dental health (GRIN): multi module online training
Control/Unexposed
no intervention
Overall Study
STARTED
71
72
Overall Study
COMPLETED
62
45
Overall Study
NOT COMPLETED
9
27

Reasons for withdrawal

Reasons for withdrawal
Measure
Exposed to GRIN Training
participates in the intervention professional development training for CHWs on dental health (GRIN): multi module online training
Control/Unexposed
no intervention
Overall Study
Lost to Follow-up
9
27

Baseline Characteristics

Two control participants left this answer blank.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Exposed to GRIN Training
n=62 Participants
participates in the intervention professional development training for CHWs on dental health (GRIN): multi module online training
Control/Unexposed
n=45 Participants
no intervention
Total
n=107 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=62 Participants • Two control participants left this answer blank.
0 Participants
n=43 Participants • Two control participants left this answer blank.
0 Participants
n=105 Participants • Two control participants left this answer blank.
Age, Categorical
Between 18 and 65 years
61 Participants
n=62 Participants • Two control participants left this answer blank.
43 Participants
n=43 Participants • Two control participants left this answer blank.
104 Participants
n=105 Participants • Two control participants left this answer blank.
Age, Categorical
>=65 years
1 Participants
n=62 Participants • Two control participants left this answer blank.
0 Participants
n=43 Participants • Two control participants left this answer blank.
1 Participants
n=105 Participants • Two control participants left this answer blank.
Sex: Female, Male
Female
57 Participants
n=61 Participants • One treatment and two control participants left this question blank.
35 Participants
n=43 Participants • One treatment and two control participants left this question blank.
92 Participants
n=104 Participants • One treatment and two control participants left this question blank.
Sex: Female, Male
Male
4 Participants
n=61 Participants • One treatment and two control participants left this question blank.
8 Participants
n=43 Participants • One treatment and two control participants left this question blank.
12 Participants
n=104 Participants • One treatment and two control participants left this question blank.
Ethnicity (NIH/OMB)
Hispanic or Latino
11 Participants
n=60 Participants • Two treatment and three control group participants left this question blank.
16 Participants
n=42 Participants • Two treatment and three control group participants left this question blank.
27 Participants
n=102 Participants • Two treatment and three control group participants left this question blank.
Ethnicity (NIH/OMB)
Not Hispanic or Latino
48 Participants
n=60 Participants • Two treatment and three control group participants left this question blank.
26 Participants
n=42 Participants • Two treatment and three control group participants left this question blank.
74 Participants
n=102 Participants • Two treatment and three control group participants left this question blank.
Ethnicity (NIH/OMB)
Unknown or Not Reported
1 Participants
n=60 Participants • Two treatment and three control group participants left this question blank.
0 Participants
n=42 Participants • Two treatment and three control group participants left this question blank.
1 Participants
n=102 Participants • Two treatment and three control group participants left this question blank.
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=39 Participants • 23 treatment and 2 control left this question blank.
2 Participants
n=43 Participants • 23 treatment and 2 control left this question blank.
2 Participants
n=82 Participants • 23 treatment and 2 control left this question blank.
Race (NIH/OMB)
Asian
0 Participants
n=39 Participants • 23 treatment and 2 control left this question blank.
1 Participants
n=43 Participants • 23 treatment and 2 control left this question blank.
1 Participants
n=82 Participants • 23 treatment and 2 control left this question blank.
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
1 Participants
n=39 Participants • 23 treatment and 2 control left this question blank.
0 Participants
n=43 Participants • 23 treatment and 2 control left this question blank.
1 Participants
n=82 Participants • 23 treatment and 2 control left this question blank.
Race (NIH/OMB)
Black or African American
19 Participants
n=39 Participants • 23 treatment and 2 control left this question blank.
16 Participants
n=43 Participants • 23 treatment and 2 control left this question blank.
35 Participants
n=82 Participants • 23 treatment and 2 control left this question blank.
Race (NIH/OMB)
White
15 Participants
n=39 Participants • 23 treatment and 2 control left this question blank.
14 Participants
n=43 Participants • 23 treatment and 2 control left this question blank.
29 Participants
n=82 Participants • 23 treatment and 2 control left this question blank.
Race (NIH/OMB)
More than one race
1 Participants
n=39 Participants • 23 treatment and 2 control left this question blank.
7 Participants
n=43 Participants • 23 treatment and 2 control left this question blank.
8 Participants
n=82 Participants • 23 treatment and 2 control left this question blank.
Race (NIH/OMB)
Unknown or Not Reported
3 Participants
n=39 Participants • 23 treatment and 2 control left this question blank.
3 Participants
n=43 Participants • 23 treatment and 2 control left this question blank.
6 Participants
n=82 Participants • 23 treatment and 2 control left this question blank.
Highest education level completed
Highschool diploma/GED
1 Participants
n=62 Participants • 2 control participants left this question blank
5 Participants
n=43 Participants • 2 control participants left this question blank
6 Participants
n=105 Participants • 2 control participants left this question blank
Highest education level completed
Some college
20 Participants
n=62 Participants • 2 control participants left this question blank
9 Participants
n=43 Participants • 2 control participants left this question blank
29 Participants
n=105 Participants • 2 control participants left this question blank
Highest education level completed
College degree
33 Participants
n=62 Participants • 2 control participants left this question blank
22 Participants
n=43 Participants • 2 control participants left this question blank
55 Participants
n=105 Participants • 2 control participants left this question blank
Highest education level completed
Master's degree
5 Participants
n=62 Participants • 2 control participants left this question blank
5 Participants
n=43 Participants • 2 control participants left this question blank
10 Participants
n=105 Participants • 2 control participants left this question blank
Highest education level completed
Professional degree
3 Participants
n=62 Participants • 2 control participants left this question blank
2 Participants
n=43 Participants • 2 control participants left this question blank
5 Participants
n=105 Participants • 2 control participants left this question blank
Length of time serving as a community health worker
Less than 6 months
6 Participants
n=60 Participants • Two participants from each group left this question blank.
5 Participants
n=43 Participants • Two participants from each group left this question blank.
11 Participants
n=103 Participants • Two participants from each group left this question blank.
Length of time serving as a community health worker
6 to 11 months
7 Participants
n=60 Participants • Two participants from each group left this question blank.
7 Participants
n=43 Participants • Two participants from each group left this question blank.
14 Participants
n=103 Participants • Two participants from each group left this question blank.
Length of time serving as a community health worker
1 to 2 years
18 Participants
n=60 Participants • Two participants from each group left this question blank.
13 Participants
n=43 Participants • Two participants from each group left this question blank.
31 Participants
n=103 Participants • Two participants from each group left this question blank.
Length of time serving as a community health worker
3 to 4 years
9 Participants
n=60 Participants • Two participants from each group left this question blank.
12 Participants
n=43 Participants • Two participants from each group left this question blank.
21 Participants
n=103 Participants • Two participants from each group left this question blank.
Length of time serving as a community health worker
5 or more years
20 Participants
n=60 Participants • Two participants from each group left this question blank.
6 Participants
n=43 Participants • Two participants from each group left this question blank.
26 Participants
n=103 Participants • Two participants from each group left this question blank.
Paid or volunteer CHW position
Paid
55 Participants
n=61 Participants • One treatment and two control participants left this question blank.
33 Participants
n=43 Participants • One treatment and two control participants left this question blank.
88 Participants
n=104 Participants • One treatment and two control participants left this question blank.
Paid or volunteer CHW position
Volunteer
2 Participants
n=61 Participants • One treatment and two control participants left this question blank.
3 Participants
n=43 Participants • One treatment and two control participants left this question blank.
5 Participants
n=104 Participants • One treatment and two control participants left this question blank.
Paid or volunteer CHW position
Both paid and volunteer
4 Participants
n=61 Participants • One treatment and two control participants left this question blank.
7 Participants
n=43 Participants • One treatment and two control participants left this question blank.
11 Participants
n=104 Participants • One treatment and two control participants left this question blank.
Number of hours of community health worker training
None
2 Participants
n=61 Participants • One treatment and three control participants left this question blank.
0 Participants
n=42 Participants • One treatment and three control participants left this question blank.
2 Participants
n=103 Participants • One treatment and three control participants left this question blank.
Number of hours of community health worker training
1 to 5 hours
3 Participants
n=61 Participants • One treatment and three control participants left this question blank.
0 Participants
n=42 Participants • One treatment and three control participants left this question blank.
3 Participants
n=103 Participants • One treatment and three control participants left this question blank.
Number of hours of community health worker training
6 to 10 hours
2 Participants
n=61 Participants • One treatment and three control participants left this question blank.
1 Participants
n=42 Participants • One treatment and three control participants left this question blank.
3 Participants
n=103 Participants • One treatment and three control participants left this question blank.
Number of hours of community health worker training
11 to 15 hours
4 Participants
n=61 Participants • One treatment and three control participants left this question blank.
1 Participants
n=42 Participants • One treatment and three control participants left this question blank.
5 Participants
n=103 Participants • One treatment and three control participants left this question blank.
Number of hours of community health worker training
16+ hours
50 Participants
n=61 Participants • One treatment and three control participants left this question blank.
40 Participants
n=42 Participants • One treatment and three control participants left this question blank.
90 Participants
n=103 Participants • One treatment and three control participants left this question blank.
Previously received training about oral health for children/adolescents
Yes
15 Participants
n=61 Participants • One treatment and two control participants left this question blank.
13 Participants
n=43 Participants • One treatment and two control participants left this question blank.
28 Participants
n=104 Participants • One treatment and two control participants left this question blank.
Previously received training about oral health for children/adolescents
No
43 Participants
n=61 Participants • One treatment and two control participants left this question blank.
28 Participants
n=43 Participants • One treatment and two control participants left this question blank.
71 Participants
n=104 Participants • One treatment and two control participants left this question blank.
Previously received training about oral health for children/adolescents
Don't know
3 Participants
n=61 Participants • One treatment and two control participants left this question blank.
2 Participants
n=43 Participants • One treatment and two control participants left this question blank.
5 Participants
n=104 Participants • One treatment and two control participants left this question blank.

PRIMARY outcome

Timeframe: Baseline

We asked participants 12 multiple choice knowledge questions related to oral health which we averaged to create a composite knowledge score for each participant ranging from 0 to 100. A score of 0 meant a participant got zero questions correct while a score of 100 meant a participant got all questions correct. We averaged these composite scores across all participants for both groups to create mean scores ranging from 0 to 100, the higher the score the more questions participants answered correctly.

Outcome measures

Outcome measures
Measure
Exposed to GRIN Training
n=62 Participants
participates in the intervention professional development training for CHWs on dental health (GRIN): multi module online training
Control/Unexposed
n=45 Participants
no intervention
Knowledge Pretest Score
64.92 score on a scale
Standard Deviation 20.03
66.67 score on a scale
Standard Deviation 17.04

PRIMARY outcome

Timeframe: Baseline

Population: 11 treatment and 3 control participants did not answer all of the individual outcome questions and thus did not have composite scores included in the final average scores.

We asked all participants seven Likert-type scale questions about attitudes towards conducting oral health outreach. Each answer choice rating ranged from 1 to 10, with higher ratings representing higher perceptions of oral health outreach importance. We averaged ratings from each question to create an average composite rating for each participant ranging from 0 to 10, with 0 being the lowest score and 10 being the highest. Higher score means better outcome. Then, we averaged these composite scores for each group.

Outcome measures

Outcome measures
Measure
Exposed to GRIN Training
n=51 Participants
participates in the intervention professional development training for CHWs on dental health (GRIN): multi module online training
Control/Unexposed
n=42 Participants
no intervention
Attitudes Pretest Score
8.46 score on a scale
Standard Deviation 0.88
8.60 score on a scale
Standard Deviation 0.85

PRIMARY outcome

Timeframe: Baseline

Population: 11 treatment and 2 control participants did not answer all of the individual outcome questions and thus did not have composite scores included in the final average scores.

We asked all participants 10 Likert-type scale questions related to perceived self-efficacy with conducting oral health outreach. Each rating ranged from 1 to 10, with higher ratings representing higher perceptions of confidence in providing oral health outreach. We averaged ratings from each question to create an average composite rating for each participant ranging from 0 to 10, with 0 being the lowest possible score and 10 being the highest score. Higher scores mean better outcomes. Then, averaged these composite scores for both groups.

Outcome measures

Outcome measures
Measure
Exposed to GRIN Training
n=51 Participants
participates in the intervention professional development training for CHWs on dental health (GRIN): multi module online training
Control/Unexposed
n=43 Participants
no intervention
Self-efficacy Pretest Score
8.16 score on a scale
Standard Deviation 1.90
7.93 score on a scale
Standard Deviation 2.22

PRIMARY outcome

Timeframe: Baseline

Population: 10 treatment and 8 control participants did not answer all of the individual outcome questions and thus did not have composite scores included in the final average scores.

We asked all participants five Likert-type scale questions related to their intentions to conduct oral health outreach. Each rating ranged from 1 to 10, with higher ratings representing higher perceived likelihood of providing oral health outreach in the future. We averaged ratings from each question to create an average composite rating for each participant ranging from 0 to 10, with 0 being the lowest possible score and 10 being the highest score. Higher scores mean better outcomes. Then, averaged these composite scores for each group.

Outcome measures

Outcome measures
Measure
Exposed to GRIN Training
n=52 Participants
participates in the intervention professional development training for CHWs on dental health (GRIN): multi module online training
Control/Unexposed
n=37 Participants
no intervention
Intentions Pretest Score
7.39 score on a scale
Standard Deviation 2.32
7.23 score on a scale
Standard Deviation 2.89

PRIMARY outcome

Timeframe: Posttest (2 weeks after baseline)

We asked participants 12 multiple choice knowledge questions related to oral health which we averaged to create a composite knowledge score for each participant ranging from 0 to 100. A score of 0 meant a participant got zero questions correct while a score of 100 meant a participant got all questions correct. We averaged these composite scores across all participants for both groups to create mean scores ranging from 0 to 100. Higher scores mean better outcome.

Outcome measures

Outcome measures
Measure
Exposed to GRIN Training
n=62 Participants
participates in the intervention professional development training for CHWs on dental health (GRIN): multi module online training
Control/Unexposed
n=45 Participants
no intervention
Knowledge Posttest Score
79.44 score on a scale
Standard Deviation 13.97
67.22 score on a scale
Standard Deviation 15.83

PRIMARY outcome

Timeframe: Posttest (2 weeks after baseline)

Population: 16 treatment and 6 control participants did not answer all of the individual outcome questions and thus did not have composite scores included in the final average scores.

We asked all participants seven Likert-type scale questions about attitudes towards conducting oral health outreach. Each rating ranged from 1 to 10, with higher ratings representing higher perceptions of oral health outreach importance. We averaged ratings from each question to create an average composite rating for each participant ranging from 0 to 10, with 0 being the lowest possible score and 10 being the highest score. Higher scores mean better outcomes. Then, averaged these composite scores for each group.

Outcome measures

Outcome measures
Measure
Exposed to GRIN Training
n=46 Participants
participates in the intervention professional development training for CHWs on dental health (GRIN): multi module online training
Control/Unexposed
n=39 Participants
no intervention
Attitudes Posttest Score
8.45 score on a scale
Standard Deviation 0.99
8.62 score on a scale
Standard Deviation 0.67

PRIMARY outcome

Timeframe: Posttest (2 weeks after baseline)

Population: 3 treatment and 5 control participants did not answer all of the individual outcome questions and thus did not have composite scores included in the final average scores.

We asked all participants 10 Likert-type scale questions related to perceived self-efficacy with conducting oral health outreach. Each rating ranged from 1 to 10, with higher ratings representing higher perceptions of confidence in providing oral health outreach. We averaged ratings from each question to create an average composite rating for each participant ranging from 0 to 10, with 0 being the lowest possible score and 10 being the highest score. Higher scores mean better outcomes. Then, averaged these composite scores for each group.

Outcome measures

Outcome measures
Measure
Exposed to GRIN Training
n=59 Participants
participates in the intervention professional development training for CHWs on dental health (GRIN): multi module online training
Control/Unexposed
n=40 Participants
no intervention
Self-efficacy Posttest Score
9.36 score on a scale
Standard Deviation 1.08
8.48 score on a scale
Standard Deviation 1.75

PRIMARY outcome

Timeframe: Posttest (2 weeks after baseline)

Population: 6 treatment and 5 control participants did not answer all of the individual outcome questions and thus did not have composite scores included in the final average scores.

We asked all participants five Likert-type scale questions related to their intentions to conduct oral health outreach. Each rating ranged from 1 to 10, with higher ratings representing higher perceived likelihood of providing oral health outreach in the future. We averaged ratings from each question to create an average composite rating for each participant ranging from 0 to 10, with 0 being the lowest possible score and 10 being the highest score. Higher scores mean better outcomes. Then, averaged these composite scores for each group.

Outcome measures

Outcome measures
Measure
Exposed to GRIN Training
n=56 Participants
participates in the intervention professional development training for CHWs on dental health (GRIN): multi module online training
Control/Unexposed
n=40 Participants
no intervention
Intentions Posttest Score
8.38 score on a scale
Standard Deviation 1.77
8.10 score on a scale
Standard Deviation 2.20

SECONDARY outcome

Timeframe: Baseline (2 weeks after baseline)

Population: 28 treatment participants did not answer all of the individual satisfaction outcome questions and thus did not have composite scores included in the final average score.

We asked only the intervention group participants five Likert-type scale questions related to their satisfaction with the GRIN intervention. Each rating ranged from 1 to 5, with higher scores representing higher satisfaction with the GRIN intervention. We averaged ratings from each question to create an average composite rating for each intervention participant, then averaged these scores across the intervention group. Scores ranged from 1 to 5, with higher scores meaning better satisfaction/outcome.

Outcome measures

Outcome measures
Measure
Exposed to GRIN Training
n=34 Participants
participates in the intervention professional development training for CHWs on dental health (GRIN): multi module online training
Control/Unexposed
no intervention
Satisfaction at Posttest Score
4.49 score on a scale
Standard Deviation 0.46

POST_HOC outcome

Timeframe: From baseline to posttest (2 weeks)

Population: Lower numbers were analyzed for both groups in the regression analyses due to missing data in the control variables.

At both pretest and posttest, we asked all participants the same 12 multiple choice knowledge questions related to oral health, which we averaged to create a composite knowledge score for each participant ranging from 0 to 100. A score of 0 meant a participant got zero questions correct while a score of 100 meant a participant got all questions correct. We averaged these composite scores across all participants for both groups to create mean scores. We then subtracted pretest scores from posttest scores and averaged these changes for all participants as the dependent variable in multiple regression. Higher scores mean higher gains from baseline to posttest. We used group assignment (intervention or treatment) as the main independent variable while controlling for participant baseline characteristics and demographics.

Outcome measures

Outcome measures
Measure
Exposed to GRIN Training
n=31 Participants
participates in the intervention professional development training for CHWs on dental health (GRIN): multi module online training
Control/Unexposed
n=36 Participants
no intervention
Change in Knowledge Scores From Pretest to Posttest
14.52 score on a scale
Standard Deviation 17.98
0.56 score on a scale
Standard Deviation 13.22

POST_HOC outcome

Timeframe: From baseline to posttest (2 weeks)

Population: Lower numbers were analyzed for both groups in the regression analyses due to missing data in the control variables.

We asked all participants seven Likert-type scale questions about attitudes towards conducting oral health outreach. Each rating ranged from 1 to 10, with higher ratings representing higher perceptions of oral health outreach importance. We averaged ratings from each question to create an average composite rating for each participant, then averaged these composite scores for both groups. We then subtracted pretest scores from posttest scores and averaged these changes for all participants as the dependent variable in multiple regression. Higher scores mean higher gains from baseline to posttest. We used group assignment (intervention or treatment) as the main independent variable while controlling for participant baseline characteristics and demographics.

Outcome measures

Outcome measures
Measure
Exposed to GRIN Training
n=23 Participants
participates in the intervention professional development training for CHWs on dental health (GRIN): multi module online training
Control/Unexposed
n=29 Participants
no intervention
Change in Attitude Scores From Pretest to Posttest
-0.07 score on a scale
Standard Deviation 1.27
0.05 score on a scale
Standard Deviation 0.86

POST_HOC outcome

Timeframe: From baseline to posttest (2 weeks)

Population: Lower numbers were analyzed for both groups in the regression analyses due to missing data in the control variables.

We asked all participants 10 Likert-type scale questions related to perceived self-efficacy with conducting oral health outreach. Each rating ranged from 1 to 10, with higher ratings representing higher perceptions of confidence in providing oral health outreach. We averaged ratings from each question to create an average composite rating for each participant, then averaged these composite scores for both groups. We then subtracted pretest scores from posttest scores and averaged these changes for all participants as the dependent variable in multiple regression. Higher scores mean higher gains from baseline to posttest. We used group assignment (intervention or treatment) as the main independent variable while controlling for participant baseline characteristics and demographics.

Outcome measures

Outcome measures
Measure
Exposed to GRIN Training
n=26 Participants
participates in the intervention professional development training for CHWs on dental health (GRIN): multi module online training
Control/Unexposed
n=29 Participants
no intervention
Change in Self-efficacy Scores From Pretest to Posttest
1.14 score on a scale
Standard Deviation 0.24
0.46 score on a scale
Standard Deviation 1.00

POST_HOC outcome

Timeframe: From baseline to posttest (2 weeks)

Population: Lower numbers were analyzed for both groups in the regression analyses due to missing data in the control variables.

We asked all participants five Likert-type scale questions related to their intentions to conduct oral health outreach. Each rating ranged from 1 to 10, with higher ratings representing higher perceived likelihood of providing oral health outreach in the future. We averaged ratings from each question to create an average composite rating for each participant, then averaged these composite scores for both groups. We then subtracted pretest scores from posttest scores and averaged these changes for all participants as the dependent variable in multiple regression. Higher scores mean higher gains from baseline to posttest. We used group assignment (intervention or treatment) as the main independent variable while controlling for participant baseline characteristics and demographics.

Outcome measures

Outcome measures
Measure
Exposed to GRIN Training
n=28 Participants
participates in the intervention professional development training for CHWs on dental health (GRIN): multi module online training
Control/Unexposed
n=27 Participants
no intervention
Change in Intentions Scores From Pretest to Posttest
0.68 score on a scale
Standard Deviation 2.29
1.13 score on a scale
Standard Deviation 2.09

Adverse Events

Exposed to GRIN Training

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Control/Unexposed

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

President

KDH Research & Communication Inc.

Phone: 4043958711

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place