- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05511935
Testing Preliminary Effectiveness of a Training to Support CHWs Outreach on Dental to African American Caregivers (GRIN)
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Georgia
-
Atlanta, Georgia, United States, 30309
- KDH Research & Communication
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion criteria:
-None
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: exposed to GRIN training
participates in the intervention
|
multi module online training
|
|
No Intervention: control/unexposed
no intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Baseline
|
|
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.
|
Baseline
|
|
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.
|
Baseline
|
|
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.
|
Baseline
|
|
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.
|
Posttest (2 weeks after baseline)
|
|
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.
|
Posttest (2 weeks after baseline)
|
|
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.
|
Posttest (2 weeks after baseline)
|
|
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.
|
Posttest (2 weeks after baseline)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Satisfaction at Posttest Score
Time Frame: Baseline (2 weeks after baseline)
|
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.
|
Baseline (2 weeks after baseline)
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Eric C Twombly, PhD, KDH Research & Communication
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2022-02-04
- 1R43MD016352 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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