NCT06049043

Brief Summary

Two arm study, experimental and control, to explore the impact of an online training program to prepare community health workers (CHWs) conduct effective outreach to support African American and Latino male caregivers of older adults.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
107

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 22, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2023

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2023

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

September 15, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 21, 2023

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

April 11, 2025

Completed
Last Updated

April 11, 2025

Status Verified

April 1, 2025

Enrollment Period

3 months

First QC Date

September 15, 2023

Results QC Date

January 6, 2024

Last Update Submit

April 10, 2025

Conditions

Keywords

MaleBlack or African AmericanHispanic or LatinoFeasibility Studies

Outcome Measures

Primary Outcomes (8)

  • Knowledge Pretest

    We asked participants 16 identically worded knowledge-based multiple-choice questions during the pretest and posttest. For each participant, we averaged their correct scores from these knowledge questions, resulting in a score that ranged from 0 to 100, with 0 as the minimum score and 100 as the maximum score. Higher scores indicate better outcomes. We then averaged these individual scores across all participants to create a composite average knowledge score for group comparisons, also ranging from 0 to 100.

    Baseline

  • Skills Pretest

    We asked participants eight identically worded skills-based multiple-choice questions at pretest and posttest. For each participant, we averaged their correct scores from these skills questions, resulting in a score that ranged from 0 to 100, with 0 as the minimum score and 100 as the maximum score. Higher scores indicate better outcomes. We then averaged these individual scores across all participants to create a composite average skills score for group comparisons, also ranging from 0 to 100.

    Baseline

  • Self-efficacy Pretest

    We asked participants 15 identically worded questions relating to their perceived self-efficacy/confidence in providing outreach to male caregivers. Each answer choice was a 10-point confidence rating scale, ranging from 1 (not very confident) to 10 (very confident), with higher scores indicating better outcomes. We averaged self-efficacy scores across all self-efficacy questions for each participant, then averaged these scores across all participants for group comparisons.

    Baseline

  • Knowledge Posttest

    We asked participants 16 identically worded knowledge-based multiple-choice questions during the pretest and posttest. For each participant, we averaged their correct scores from these knowledge questions, resulting in a score that ranged from 0 to 100, with 0 as the minimum score and 100 as the maximum score. Higher scores indicate better outcomes. We then averaged these individual scores across all participants to create a composite average knowledge score for group comparisons, also ranging from 0 to 100.

    2 weeks

  • Skills Posttest

    We asked participants eight identically worded skills-based multiple-choice questions at pretest and posttest. For each participant, we averaged their correct scores from these skills questions, resulting in a score that ranged from 0 to 100, with 0 as the minimum score and 100 as the maximum score. Higher scores indicate better outcomes. We then averaged these individual scores across all participants to create a composite average skills score for group comparisons, also ranging from 0 to 100.

    2 weeks

  • Self-efficacy Posttest

    We asked participants 15 identically worded questions relating to their perceived self-efficacy/confidence in providing outreach to male caregivers. Each answer choice was a 10-point confidence rating scale, ranging from 1 (not very confident) to 10 (very confident), with higher scores indicating better outcomes. We averaged self-efficacy scores across all self-efficacy questions for each participant, then averaged these scores across all participants for group comparisons.

    2 weeks

  • Preparedness Posttest

    We asked participants six identically worded questions relating to their perceived preparedness to deliver male caregiver outreach at pretest and posttest. Each answer choice was a 10-point confidence rating scale, ranging from 1 (not at all prepared) to 10 (very much prepared), with higher scores indicating better outcomes. We averaged scores from each preparedness question for each participant, then averaged these scores across all participants for group comparisons.

    2 weeks

  • Preparedness Pretest

    We asked participants six identically worded questions relating to their perceived preparedness to deliver male caregiver outreach at pretest and posttest. Each answer choice was a 10-point confidence rating scale, ranging from 1 (not at all prepared) to 10 (very much prepared), with higher scores indicating better outcomes. We averaged scores from each preparedness question for each participant, then averaged these scores across all participants for group comparisons.

    Baseline

Secondary Outcomes (1)

  • Satisfaction Composite Scores at Posttest

    2/3 weeks

Study Arms (2)

Intervention to Help Orient Men to Excel (IN-HOME)

EXPERIMENTAL

Professional development training for CHWs on African American and Latino male caregiver needs

Other: Intervention to Help Orient Men to Excel (IN-HOME)

Control

OTHER

AARP's English "Care at Home" resource webpage

Other: AARP's English "Care at Home" resource webpage

Interventions

A multi module online training

Intervention to Help Orient Men to Excel (IN-HOME)

Caregiver information from the American Association of Retired Persons

Control

Eligibility Criteria

Age18 Years - 95 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

KDH Research & Communication

Atlanta, Georgia, 30309, United States

Location

MeSH Terms

Conditions

Caregiver Burden

Condition Hierarchy (Ancestors)

Stress, PsychologicalBehavioral SymptomsBehavior

Results Point of Contact

Title
Andrew Simkus, Research Analyst
Organization
KDHRC

Study Officials

  • Eric C Twombly, PhD

    KDH Research & Communication

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 15, 2023

First Posted

September 21, 2023

Study Start

May 22, 2023

Primary Completion

August 15, 2023

Study Completion

August 31, 2023

Last Updated

April 11, 2025

Results First Posted

April 11, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations