Caregiver BurnoutIN-HOMENCT06049043
Testing Preliminary Effectiveness of a Community Health Worker (CHW) Training Program on Caregiving
A study testing Intervention to Help Orient Men to Excel (IN-HOME) and AARP's English "Care at Home" resource webpage in people with Caregiver Burnout, run by KDH Research & Communication at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 95 yearsHealthy volunteers can take part
- Conditions the study is for
- Caregiver Burnout
- What is being tested?
- Intervention to Help Orient Men to Excel (IN-HOME) and AARP's English "Care at Home" resource webpage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 107 participants
- Where
- 1 siteUnited States
- Study dates
- 22 May 2023to 31 Aug 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 95 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
KDH Research & Communication
Atlanta, Georgia, 30309
About this study
Official title: Testing Preliminary Effectiveness of a Community Health Worker (CHW) Training Program to Support African American and Latino Male Caregivers of Older Adults
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.
Read the 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 Community Health Workers' (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 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 the online data collection system 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.
- Conditions
- Caregiver Burnout
- Being tested
- Intervention to Help Orient Men to Excel (IN-HOME), AARP's English "Care at Home" resource webpage
- Keywords
- Male, Black or African American, Hispanic or Latino, Feasibility Studies
- Medical subject headings
- Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention to Help Orient Men to Excel (IN-HOME)Other
A multi module online training
AARP's English "Care at Home" resource webpageOther
Caregiver information from the American Association of Retired Persons
| Study group | Role | What they receive |
|---|---|---|
| Intervention to Help Orient Men to Excel (IN-HOME) | Experimental | Professional development training for CHWs on African American and Latino male caregiver needs Receives: Other: Intervention to Help Orient Men to Excel (IN-HOME) |
| Control | Other | AARP's English "Care at Home" resource webpage Receives: Other: AARP's English "Care at Home" resource webpage |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline
Secondary outcomes (1)
Satisfaction Composite Scores at Posttest
We asked intervention group participants five questions about their satisfaction with IN-HOME at posttest. All five satisfaction questions were ratings assessing the participants' perceptions of ease, relevance, engagement, usefulness, and likeliness to tell others about IN-HOME. Each answer choice ranged from 1 to 10, with 10 representing the highest and 1 representing the lowest rating. We averaged satisfaction ratings across all five questions for each intervention participant and averaged these scores across all intervention participants to create a single composite score ranging from 1 to 10, with higher scores indicating higher satisfaction.
Measured: 2/3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start22 May 2023
- Primary completion15 Aug 2023
- Study completion31 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Caregiver BurnoutStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- KDH Research & Communication
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eric C Twombly, PhD, Study chair, KDH Research & Communication
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06049043
- Sponsor's protocol ID
- 2023-02-10
- Acronym
- IN-HOME
- Status last verified
- Apr 2025
- First submitted
- 15 Sep 2023
- Last updated
- 11 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing Preliminary Effectiveness of a Community Health Worker (CHW) Training Program to Support African American and Latino Male Caregivers of Older Adults
- ClinicalTrials.gov ID
- NCT06049043
- Acronym / sponsor ID
- IN-HOME / 2023-02-10
- Conditions
- Caregiver Burnout
- Keywords
- Male, Black or African American, Hispanic or Latino, Feasibility Studies
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- KDH Research & CommunicationIndustry (pharma, biotech, devices)
- Study start
- 22 May 2023 (actual)
- Primary completion
- 15 Aug 2023 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 21 Sep 2023 (actual)
- Results
- Posted 11 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 Community Health Workers' (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 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 the online data collection system 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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention to Help Orient Men to Excel (IN-HOME) | Experimental | Other: Intervention to Help Orient Men to Excel (IN-HOME)Professional development training for CHWs on African American and Latino male caregiver needs |
| Control | Other | Other: AARP's English "Care at Home" resource webpageAARP's English "Care at Home" resource webpage |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention to Help Orient Men to Excel (IN-HOME)A multi module online training | Other | Intervention to Help Orient Men to Excel (IN-HOME) |
| AARP's English "Care at Home" resource webpageCaregiver information from the American Association of Retired Persons | Other | Control |
Primary outcome
Knowledge Pretest
Time frame: Baseline
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.
Skills Pretest
Time frame: Baseline
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.
Self-efficacy Pretest
Time frame: Baseline
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.
Knowledge Posttest
Time frame: 2 weeks
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.
Skills Posttest
Time frame: 2 weeks
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.
Self-efficacy Posttest
Time frame: 2 weeks
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.
Preparedness Posttest
Time frame: 2 weeks
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.
Preparedness Pretest
Time frame: Baseline
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.
1 secondary outcome
Satisfaction Composite Scores at Posttest
Time frame: 2/3 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric C Twombly, PhD study chair
KDH Research & Communication
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention to Help Orient Men to Excel (IN-HOME) and AARP's English "Care at Home" resource webpage in people with Caregiver Burnout, run by KDH Research & Communication at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knowledge Pretest (time frame: Baseline). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2025.