Testing Preliminary Effectiveness of a Training to Support CHWs Outreach on Dental to African American Caregivers (GRIN)

November 6, 2024 updated by: KDH Research & Communication
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
143

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30309
        • KDH Research & Communication

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 95 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: exposed to GRIN training
participates in the intervention
Other: professional development training for CHWs on dental health (GRIN)
multi module online training
No Intervention: control/unexposed
no intervention

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
KDH Research & Communication

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Minority Health and Health Disparities (NIMHD)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Eric C Twombly, PhD, KDH Research & Communication

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 15, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 16, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 19, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 23, 2022

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 7, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 6, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2022-02-04
  • 1R43MD016352 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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