Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT06049043 |
| Other study ID # |
2023-02-10 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 22, 2023 |
| Est. completion date |
August 31, 2023 |
Study information
| Verified date |
November 2023 |
| Source |
KDH Research & Communication |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Two arm study, experimental and control, to explore the impact of an online training program
to prepare community health workers conduct effective outreach to support African American
and Latino male caregivers of older adults.
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.
