Trial Outcomes & Findings for Coordinated Oral Health Promotion (CO-OP) Chicago (NCT NCT03397589)

NCT ID: NCT03397589

Last Updated: 2022-10-18

Results Overview

parents will be asked how often the child's teeth are brushed

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 420 participants
• Primary outcome timeframe: 12-months post-randomization
• Results posted on: 2022-10-18

Participant Flow

Participant milestones

Measure	CHW Arm The intervention is community health worker (CHW) services. CHWs trained in oral health will be assigned to half of the sites. Participants in these sites will be offered four in-person visits and follow-up phone calls over 12-months. These visits can occur at the location of the family's preference (recruitment site, home, or mutually-agreed upon other location). A core curriculum of oral health topics will be covered during visits, with an emphasis on developing and sustaining healthy oral health management routines for the entire family. Community Health Worker (CHW) services: CHWs are non-clinical people who provide education, care coordination, and support to families.	Wait-list Control Arm This arm will receive usual care. After completion of the final data collection at one year, participants and sites allotted to this arm will be offered CHW services.
Overall Study STARTED	211	209
Overall Study COMPLETED	175	187
Overall Study NOT COMPLETED	36	22

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Coordinated Oral Health Promotion (CO-OP) Chicago

Baseline characteristics by cohort

Measure	CHW Arm n=211 Participants The intervention is community health worker (CHW) services. CHWs trained in oral health will be assigned to half of the sites. Participants in these sites will be offered four in-person visits and follow-up phone calls over 12-months. These visits can occur at the location of the family's preference (recruitment site, home, or mutually-agreed upon other location). A core curriculum of oral health topics will be covered during visits, with an emphasis on developing and sustaining healthy oral health management routines for the entire family. Community Health Worker (CHW) services: CHWs are non-clinical people who provide education, care coordination, and support to families.	Wait-list Control Arm n=209 Participants This arm will receive usual care. After completion of the final data collection at one year, participants and sites allotted to this arm will be offered CHW services.	Total n=420 Participants Total of all reporting groups
Age, Continuous	22.4 months STANDARD_DEVIATION 6.8 • n=5 Participants	20.8 months STANDARD_DEVIATION 7.0 • n=7 Participants	21.5 months STANDARD_DEVIATION 6.9 • n=5 Participants
Sex: Female, Male Female	104 Participants n=5 Participants	109 Participants n=7 Participants	213 Participants n=5 Participants
Sex: Female, Male Male	107 Participants n=5 Participants	100 Participants n=7 Participants	207 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	115 Participants n=5 Participants	111 Participants n=7 Participants	226 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	96 Participants n=5 Participants	98 Participants n=7 Participants	194 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	92 Participants n=5 Participants	84 Participants n=7 Participants	176 Participants n=5 Participants
Race (NIH/OMB) White	21 Participants n=5 Participants	36 Participants n=7 Participants	57 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	98 Participants n=5 Participants	89 Participants n=7 Participants	187 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12-months post-randomization

parents will be asked how often the child's teeth are brushed

Outcome measures

Measure	CHW Arm n=175 Participants The intervention is community health worker (CHW) services. CHWs trained in oral health will be assigned to half of the sites. Participants in these sites will be offered four in-person visits and follow-up phone calls over 12-months. These visits can occur at the location of the family's preference (recruitment site, home, or mutually-agreed upon other location). A core curriculum of oral health topics will be covered during visits, with an emphasis on developing and sustaining healthy oral health management routines for the entire family. Community Health Worker (CHW) services: CHWs are non-clinical people who provide education, care coordination, and support to families.	Wait-list Control Arm n=187 Participants This arm will receive usual care. After completion of the final data collection at one year, participants and sites allotted to this arm will be offered CHW services.
Parent-reported Tooth Brushing Frequency Never brush	1 Participants	1 Participants
Parent-reported Tooth Brushing Frequency Sometimes, but not everyday brush	12 Participants	15 Participants
Parent-reported Tooth Brushing Frequency Once a day brush	56 Participants	49 Participants
Parent-reported Tooth Brushing Frequency Twice a day brush	85 Participants	105 Participants
Parent-reported Tooth Brushing Frequency More than twice a day brush	21 Participants	17 Participants

PRIMARY outcome

Timeframe: 12-months post-randomization

Disclosing solution is applied to child's teeth, images are taken, and plaque score is determined using the Oral health Index - Maxillary Incisor Score (OHI-MIS). The buccal surfaces of teeth #D, E, F, and G were scored from 0-3, with 3 being the worst (plaque on more than 2/3 of tooth surface) and 0 being the best (no plaque present). The four individual tooth scores (or less if child did not have four teeth) were then added and divided by the number of teeth for a final average score ranging from 0-3.

Outcome measures

Measure	CHW Arm n=161 Participants The intervention is community health worker (CHW) services. CHWs trained in oral health will be assigned to half of the sites. Participants in these sites will be offered four in-person visits and follow-up phone calls over 12-months. These visits can occur at the location of the family's preference (recruitment site, home, or mutually-agreed upon other location). A core curriculum of oral health topics will be covered during visits, with an emphasis on developing and sustaining healthy oral health management routines for the entire family. Community Health Worker (CHW) services: CHWs are non-clinical people who provide education, care coordination, and support to families.	Wait-list Control Arm n=160 Participants This arm will receive usual care. After completion of the final data collection at one year, participants and sites allotted to this arm will be offered CHW services.
Child Dental Plaque Score	1.88 score on a scale Standard Deviation 0.64	1.85 score on a scale Standard Deviation 0.66

Adverse Events

CHW Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Wait-list Control Arm

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

Molly A Martin, MD

University of Illinois Chicago

Phone: 312-996-2363

Email: mollyma@uic.edu

Results disclosure agreements

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