Oral HealthGRINNCT05511935
Testing Preliminary Effectiveness of a Training to Support CHWs Outreach on Dental to African American Caregivers
A study testing professional development training for CHWs on dental health (GRIN) in people with Oral Health and Child, run by KDH Research & Communication at 1 site in United States.
Trial summary
Two arm study, experimental and control, to explore the impact of an online training program to help community health workers conduct effective outreach to support the dental health of African American youth via their caregivers. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Oral Health, Child, Adolescents
- What is being tested?
- professional development training for CHWs on dental health (GRIN)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 143 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2022to 31 Aug 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Must be at least 18 years old.
- Must self-identify as a community health worker.
- Must conduct outreach to Black parents of children and adolescents.
- Must have six months of field experience. KDHRC defines "field experience" as conducting outreach activities in their community, for example, working with clients in a clinic, conducting home visits, or educating clients at health fairs or community events
- Must be an active CHW. KDHRC defines "active" as conducting outreach activities, such as working with clients in a clinic, conducting home visits, or educating clients at health fairs or community events, in the last six months.
- Must have Internet access either at home or at work to access the the GRIN virtual education session and/or online surveys.
Who cannot join
- -None
Trial locations and contacts
1 site in 1 country.
United States1 site
KDH Research & Communication
Atlanta, Georgia, 30309
About this study
Two arm study, experimental and control, to explore the impact of an online training program to help community health workers conduct effective outreach to support the dental health of African American youth via their caregivers.
Read the detailed description
The investigators will use a randomized, two-group, pretest/posttest design to test the efficacy of the GRIN prototype and explore the following research question: To what extent does exposure to the GRIN prototype relate to positive changes in CHWs' knowledge, attitudes and beliefs, perceived self-efficacy, and intent to conduct oral health care outreach to low-income Black guardians? The community-driven nature of the project will ground the evaluation in the principles of an equitable evaluation that incorporates a racial equity lens. An equitable evaluation is "an approach that addresses the dynamics and practices that have historically undervalued the voices, knowledge, expertise, capacity, and experiences of all evaluation participants and stakeholders, particularly people of color and other marginalized groups." This approach "requires that evaluators engage in a process of ongoing self-reflection and adjustment, including a willingness to question and adapt traditional evaluation methods in response to stakeholder input." Working with communities to reflect the specific needs of their constituents, investigators will develop and enhance collaborations that leverage stakeholder expertise; minimize counter-productive duplications of services and resource expenditure; and create empowered opportunities for CHWs to conduct outreach with low-income Black guardians. The PI, with input from the SC, will develop necessary research materials, including the recruitment protocols, evaluation instrumentation, and human subjects consent materials, which then be reviewed against an equitable evaluation checklist, obtaining input on revisions from community members where needed. The PI will also outline the appropriate statistical analysis methods. All procedure documents will be reviewed by the KDHRC Institutional Review Board before the evaluation launch.
The investigators will recruit participants through evaluation partners who will disseminate the study information to CHWs via electronic notifications and flyers. Evaluation partners include National Association of Community Health Workers (NACHW) and the University of Southern Mississippi College of Nursing and Health Professionals (see Letters of Support for more details). The notification will provide information about the goal of the study, participant eligibility, and a link to an interest and eligibility form. Once a potential participant completes the interest and eligibility form and s/he is eligible for the project, they will receive a link to a consent form located on a secure online platform.
CHWs will be randomly assigned to the intervention or control group after consent and enrollment in the study. All participants will complete an online pretest survey. The intervention group will be exposed to GRIN and will complete an online posttest survey two weeks after completing the GRIN modules. The control group participants will not be exposed to the GRIN program and will complete a posttest two weeks after completing the pretest. Participant responses to pretest and posttest survey measures will be linked using non-personal identifiers.
The investigators will download and export the data from SurveyGizmo into an encrypted Excel file and import the raw data into STATA. The investigators will match the pretest and posttest responses using the random assigned identifiers and conduct analyses to test for the effect of GRIN exposure on changes in CHWs' knowledge, attitudes and beliefs, self-efficacy, and intentions to conduct pediatric oral health care outreach to low-income Black guardians. The a priori feasibility criterion is: Statistically significant differences between pretest and posttest knowledge and self-efficacy measures among the intervention group participants.
- Conditions
- Oral Health, Child, Adolescents, Self Efficacy, Intention, Health Literacy
- Being tested
- professional development training for CHWs on dental health (GRIN)
- Medical subject headings
- Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
professional development training for CHWs on dental health (GRIN)Other
multi module online training
| Study group | Role | What they receive |
|---|---|---|
| exposed to GRIN training | Experimental | participates in the intervention Receives: Other: professional development training for CHWs on dental health (GRIN) |
| control/unexposed | No intervention | no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knowledge Pretest Score
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.
Measured: Baseline
Attitudes Pretest Score
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.
Measured: Baseline
Self-efficacy Pretest Score
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.
Measured: Baseline
Intentions Pretest Score
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.
Measured: Baseline
Knowledge Posttest Score
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.
Measured: Posttest (2 weeks after baseline)
Attitudes Posttest Score
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.
Measured: Posttest (2 weeks after baseline)
Self-efficacy Posttest Score
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.
Measured: Posttest (2 weeks after baseline)
Intentions Posttest Score
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.
Measured: Posttest (2 weeks after baseline)
Secondary outcomes (1)
Satisfaction at Posttest 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.
Measured: Baseline (2 weeks after baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2022
- Study start1 Jan 2022
- Primary completion15 Aug 2022
- Study completion31 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Oral HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 143 participants (actual)
Sponsor and investigators
- Lead sponsor
- KDH Research & Communication
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Sponsor
- Investigators
- Eric C Twombly, PhD, Study chair, KDH Research & Communication
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05511935
- Sponsor's protocol ID
- 2022-02-04
- Other IDs
- 1R43MD016352
- Acronym
- GRIN
- Status last verified
- Nov 2024
- First submitted
- 16 Aug 2022
- Last updated
- 7 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing Preliminary Effectiveness of a Training to Support CHWs Outreach on Dental to African American Caregivers
- ClinicalTrials.gov ID
- NCT05511935
- Acronym / sponsor ID
- GRIN / 2022-02-04
- Conditions
- Oral Health, Child, Adolescents, Self Efficacy, Intention, Health Literacy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 143 participants (actual)
- Lead sponsor
- KDH Research & CommunicationIndustry (pharma, biotech, devices)
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 15 Aug 2022 (actual)
- Study completion
- 31 Aug 2022 (actual)
- First posted
- 23 Aug 2022 (actual)
- Results
- Posted 7 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Two arm study, experimental and control, to explore the impact of an online training program to help community health workers conduct effective outreach to support the dental health of African American youth via their caregivers.
Detailed description
The investigators will use a randomized, two-group, pretest/posttest design to test the efficacy of the GRIN prototype and explore the following research question: To what extent does exposure to the GRIN prototype relate to positive changes in CHWs' knowledge, attitudes and beliefs, perceived self-efficacy, and intent to conduct oral health care outreach to low-income Black guardians? The community-driven nature of the project will ground the evaluation in the principles of an equitable evaluation that incorporates a racial equity lens. An equitable evaluation is "an approach that addresses the dynamics and practices that have historically undervalued the voices, knowledge, expertise, capacity, and experiences of all evaluation participants and stakeholders, particularly people of color and other marginalized groups." This approach "requires that evaluators engage in a process of ongoing self-reflection and adjustment, including a willingness to question and adapt traditional evaluation methods in response to stakeholder input." Working with communities to reflect the specific needs of their constituents, investigators will develop and enhance collaborations that leverage stakeholder expertise; minimize counter-productive duplications of services and resource expenditure; and create empowered opportunities for CHWs to conduct outreach with low-income Black guardians. The PI, with input from the SC, will develop necessary research materials, including the recruitment protocols, evaluation instrumentation, and human subjects consent materials, which then be reviewed against an equitable evaluation checklist, obtaining input on revisions from community members where needed. The PI will also outline the appropriate statistical analysis methods. All procedure documents will be reviewed by the KDHRC Institutional Review Board before the evaluation launch.
The investigators will recruit participants through evaluation partners who will disseminate the study information to CHWs via electronic notifications and flyers. Evaluation partners include National Association of Community Health Workers (NACHW) and the University of Southern Mississippi College of Nursing and Health Professionals (see Letters of Support for more details). The notification will provide information about the goal of the study, participant eligibility, and a link to an interest and eligibility form. Once a potential participant completes the interest and eligibility form and s/he is eligible for the project, they will receive a link to a consent form located on a secure online platform.
CHWs will be randomly assigned to the intervention or control group after consent and enrollment in the study. All participants will complete an online pretest survey. The intervention group will be exposed to GRIN and will complete an online posttest survey two weeks after completing the GRIN modules. The control group participants will not be exposed to the GRIN program and will complete a posttest two weeks after completing the pretest. Participant responses to pretest and posttest survey measures will be linked using non-personal identifiers.
The investigators will download and export the data from SurveyGizmo into an encrypted Excel file and import the raw data into STATA. The investigators will match the pretest and posttest responses using the random assigned identifiers and conduct analyses to test for the effect of GRIN exposure on changes in CHWs' knowledge, attitudes and beliefs, self-efficacy, and intentions to conduct pediatric oral health care outreach to low-income Black guardians. The a priori feasibility criterion is: Statistically significant differences between pretest and posttest knowledge and self-efficacy measures among the intervention group participants.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| exposed to GRIN training | Experimental | Other: professional development training for CHWs on dental health (GRIN)participates in the intervention |
| control/unexposed | No intervention | –no intervention |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Must be at least 18 years old.
- Must self-identify as a community health worker.
- Must conduct outreach to Black parents of children and adolescents.
- Must have six months of field experience. KDHRC defines "field experience" as conducting outreach activities in their community, for example, working with clients in a clinic, conducting home visits, or educating clients at health fairs or community events
- Must be an active CHW. KDHRC defines "active" as conducting outreach activities, such as working with clients in a clinic, conducting home visits, or educating clients at health fairs or community events, in the last six months.
Key exclusion criteria (1 listed)
- -None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| professional development training for CHWs on dental health (GRIN)multi module online training | Other | exposed to GRIN training |
Primary outcome
Knowledge Pretest Score
Time frame: 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.
Attitudes Pretest Score
Time frame: Baseline
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.
Self-efficacy Pretest Score
Time frame: Baseline
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.
Intentions Pretest Score
Time frame: Baseline
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.
Knowledge Posttest Score
Time frame: 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.
Attitudes Posttest Score
Time frame: Posttest (2 weeks after baseline)
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.
Self-efficacy Posttest Score
Time frame: Posttest (2 weeks after baseline)
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.
Intentions Posttest Score
Time frame: Posttest (2 weeks after baseline)
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.
1 secondary outcome
Satisfaction at Posttest Score
Time frame: Baseline (2 weeks after baseline)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric C Twombly, PhD study chair
KDH Research & Communication
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing professional development training for CHWs on dental health (GRIN) in people with Oral Health and Child, run by KDH Research & Communication at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knowledge Pretest Score (time frame: Baseline). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2024.