- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06049043
Testing Preliminary Effectiveness of a CHW Training Program to Support African American and Latino Male Caregivers (IN-HOME)
Testing Preliminary Effectiveness of a CHW Training Program to Support African American and Latino Male Caregivers of Older Adults
Study Overview
Status
Conditions
Detailed Description
The investigators used a randomized, two-group, pretest/posttest design to test the efficacy of the IN-HOME prototype and explore the following research question: To what extent did exposure to the IN-HOME prototype relate to positive changes in CHWs' knowledge, skills, and perceived self-efficacy to conduct outreach to African American and Latino male caregivers of older adults?
The community-focused and community-based approach of the intervention included an evaluation that required strategies to address gender preferences for resources and providing care and cultural awareness to understand the communities of focus. The evaluation recognized additional barriers such as racial/ethnic group historical experiences and racism that effects the groups health outcomes and health care interactions. To ensure that the approach was culturally appropriate and the materials were culturally relevant, the investigators worked with caregiver and health disparities researchers and CHW practitioners to create an advisory committee of experts that provided input into the development of the intervention to empower CHWs to conduct outreach to African American and Latino male caregivers. The PI, with input from the advisory committee, developed necessary research materials, including the recruitment protocols, evaluation instrumentation, and human subjects consent materials. The PI also outlined the appropriate statistical analysis methods. All procedure documents were reviewed by the KDHRC Institutional Review Board before the evaluation launch.
The investigators recruited participants through evaluation partners who disseminated the study information to CHWs via electronic notifications and flyers. Evaluation partners included sites with CHW-related programs and CHW organizations such as, the Virginia CHW Association, the Dallas-Fort Worth CHW Organization, Connection Health, and the Hispanic Health Initiative Incorporated. The notification provided information about the goal of the study, participant eligibility, and a link to an interest and eligibility form. After a potential participant completed the interest and eligibility form and determined as eligible for the project, they received a link to a consent form that was located on a secure online platform.
CHWs were randomly assigned to the intervention or control group after consent and enrollment in the study. All participants completed an online pretest survey. The intervention group was exposed to IN-HOME and completed an online posttest survey two weeks after completing the IN-HOME modules. The control group participants were not exposed to the IN-HOME program but were asked to review the AARP's English "Care at Home" resource webpage. The control group participants completed a posttest two weeks after completing the pretest. Participant responses to pretest and posttest survey measures were linked using non-personal identifiers.
The investigators downloaded and exported the data from Alchemer into an encrypted Excel file and imported the raw data into STATA. The investigators matched the pretest and posttest responses using the random assigned identifiers and conduct analyses to test for the effect of IN-HOME exposure on changes in CHWs' knowledge, skills, and self-efficacy to conduct outreach to African American and Latino male caregivers. Effectiveness measure for intervention feasibility was statistically significant differences between pretest and posttest for 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
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Must self-identify as working as a community health worker
- Must be actively employed conducting community-based outreach at an organization (paid or volunteer)
- Must be 18 years of age or older
- Must live in the United States
Exclusion Criteria:
-
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: Intervention to Help Orient Men to Excel (IN-HOME)
Professional development training for CHWs on African American and Latino male caregiver needs
|
A multi module online training
|
Other: Control
AARP's English "Care at Home" resource webpage
|
Caregiver information from the American Association of Retired Persons
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Knowledge, skills, and self-efficacy
Time Frame: Two weeks
|
Social Cognitive Theory (SCT) based behavior change model using a quantitative survey.
Investigators designed questions to assess knowledge and skills (through multiple choice questions) that are anticipated to increase for participants exposed to the intervention.
A 10-point confidence rating scale to assess self-efficacy/ confidence in performing key skills related to caregiver outreach are included.
|
Two weeks
|
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 (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023-02-10
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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