Intervention to Help Orient Men to Excel (IN-HOME) Phase II Study

NCT07704060 | Recruiting

• 2 other identifiers: 2026-05-03R44MD018249-03
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of the study is to examine the effect of outreach from IN-HOME-trained CHWs on changes in male informal caregiver knowledge/skills, positive attitudes, self-efficacy, and intentions about caregiving topics. The study will also assess the extent to which exposure to IN-HOME improves male caregivers' general, physical, and mental health and reduces interference with daily tasks due to health-related issues and satisfaction with the program and associated app.

Conditions

Caregivers; Community Health Workers; Knowledge; Attitude; Self-Efficacy; Intentions; Health

Keywords

Male; Caregivers; Health

Outcome Measures

Primary Outcomes (21)

• Declarative knowledge survey 1 score

  Investigators will ask participants multiple-choice questions about caregiving declarative knowledge. Investigators will sum to create a composite knowledge score ranging from 0 to 7. A score of 0 means a participant got zero questions correct, while a score of 7 means a participant got all 7 questions correct. Then, the investigators will create the composite knowledge average by dividing the participant's composite score by the total number of questions (7) and multiplying by 100. The higher the score, the more questions a participant answered correctly.

  Survey 1 (baseline)

• Declarative knowledge survey 2 score

  Investigators will ask participants multiple-choice questions about caregiving declarative knowledge. Investigators will sum to create a composite knowledge score ranging from 0 to 7. A score of 0 means a participant got zero questions correct, while a score of 7 means a participant got all 7 questions correct. Then, the investigators will create the composite knowledge average by dividing the participant's composite score by the total number of questions (7) and multiplying by 100. The higher the score, the more questions a participant answered correctly.

  Three weeks after survey 1

• Declarative knowledge survey 3 score

  Investigators will ask participants multiple-choice questions about caregiving declarative knowledge. Investigators will sum the scores to create a composite knowledge score ranging from 0 to 7. A score of 0 means a participant got zero questions correct, while a score of 7 means a participant got all 7 questions correct. Then, the investigators will create the composite knowledge average by dividing the participant's composite score by the total number of questions (7) and multiplying by 100. The higher the score, the more questions a participant answered correctly.

  Three weeks after survey 2

• Procedural knowledge survey 1 score

  Investigators will ask participants multiple-choice questions about caregiving procedural knowledge. Investigators will sum the scores to create a composite knowledge score ranging from 0 to 4. A score of 0 means a participant got zero questions correct, while a score of 4 means a participant got all 4 questions correct. Then, the investigators will create the composite knowledge average by dividing the participant's composite score by the total number of questions (4) and multiplying by 100. The higher the score, the more questions a participant answered correctly.

  Survey 1 (baseline)

• Procedural knowledge survey 2 score

  Investigators will ask participants multiple-choice questions about caregiving procedural knowledge. Investigators will sum the scores to create a composite knowledge score ranging from 0 to 4. A score of 0 means a participant got zero questions correct, while a score of 4 means a participant got all 4 questions correct. Then, the investigators will create the composite knowledge average by dividing the participant's composite score by the total number of questions (4) and multiplying by 100. The higher the score, the more questions a participant answered correctly.

  Three weeks after survey 1

• Procedural knowledge survey 3 score

  Investigators will ask participants multiple-choice questions about caregiving procedural knowledge. Investigators will sum the scores to create a composite knowledge score ranging from 0 to 4. A score of 0 means a participant got zero questions correct, while a score of 4 means a participant got all 4 questions correct. Then, the investigators will create the composite knowledge average by dividing the participant's composite score by the total number of questions (4) and multiplying by 100. The higher the score, the more questions a participant answered correctly.

  Three weeks after survey 2

• Skills survey 1 score

  Investigators will ask all participants Likert-type scale questions about skills to conduct caregiving tasks. Each answer choice rating will range from 1 to 10, with higher ratings representing more caregiver experience. Investigators will create the composite skills score by summing the scores from the participant's 9 skill items with a range of 9 to 90. Then, investigators will create the skills average by dividing the participant's composite score by the total number of questions (9), and the composite score will range from 1 to 10. The higher the score, the more experience a participant indicates.

  Survey 1 (baseline)

• Skills survey 2 score

  Investigators will ask all participants Likert-type scale questions about skills to conduct caregiving tasks. Each answer choice rating will range from 1 to 10, with higher ratings representing more caregiver experience. Investigators will create the composite skills score by summing the scores from the participant's 9 skill items with a range of 9 to 90. Then, investigators will create the skills average by dividing the participant's composite score by the total number of questions (9), and the score will range from 1 to 10. The higher the score, the more experience a participant indicates.

  Three weeks after survey 1

• Skills survey 3 score

  Investigators will ask all participants Likert-type scale questions about skills to conduct caregiving tasks. Each answer choice rating will range from 1 to 10, with higher ratings representing more caregiver experience. Investigators will create the composite skills score by summing the scores from the participant's 9 skill items with a range of 9 to 90. Then, investigators will create the skills average by dividing the participant's composite score by the total number of questions (9), and the score will range from 1 to 10. The higher the score, the more experience a participant indicates.

  Three weeks after survey 2

• Positive attitudes survey 1 score

  Investigators will ask all participants Likert-type scale questions about attitudes toward CHW support and caregiving. Each answer choice rating will range from 1 to 10, with higher ratings representing more positive attitudes. Investigators will create the composite attitudes score by summing the scores from the participant's 4 attitude items with a range of 4 to 40. Then, investigators will create the attitudes average by dividing the participant's composite score by the total number of questions (4), and the score will range from 1 to 10. The higher the score, the more experience a participant indicates.

  Survey 1 (baseline)

• Positive attitudes survey 2 score

  Investigators will ask all participants Likert-type scale questions about attitudes toward CHW support and caregiving. Each answer choice rating will range from 1 to 10, with higher ratings representing more positive attitudes. Investigators will create the composite attitudes score by summing the scores from the participant's 4 attitude items with a range of 4 to 40. Then, investigators will create the attitudes average by dividing the participant's composite score by the total number of questions (4), and the score will range from 1 to 10. The higher the score, the more experience a participant indicates.

  Three weeks after survey 1

• Positive attitudes survey 3 score

  Investigators will ask all participants Likert-type scale questions about attitudes toward CHW support and caregiving. Each answer choice rating will range from 1 to 10, with higher ratings representing more positive attitudes. Investigators will create the composite attitudes score by summing the scores from the participant's 4 attitude items with a range of 4 to 40. Then, investigators will create the attitudes average by dividing the participant's composite score by the total number of questions (4), and the score will range from 1 to 10. The higher the score, the more experience a participant indicates.

  Three weeks after survey 2

• Self-efficacy survey 1 score

  Investigators will ask all participants Likert-type scale questions related to perceived self-efficacy with conducting caregiving tasks. Each rating will range from 1 to 10, with higher ratings representing higher perceptions of confidence in conducting caregiving tasks. Investigators will create the composite self-efficacy score by summing the scores from the participant's 7 self-efficacy items with a range of 7 to 70. Then, investigators will create the self-efficacy average by dividing the participant's score by the number of self-efficacy items (7). The composite will range from 1 to 10.

  Survey 1 (baseline)

• Self-efficacy survey 2 score

  Investigators will ask all participants Likert-type scale questions related to perceived self-efficacy with conducting caregiving tasks. Each rating will range from 1 to 10, with higher ratings representing higher perceptions of confidence in conducting caregiving tasks. Investigators will create the composite self-efficacy score by summing the scores from the participant's 7 self-efficacy items with a range of 7 to 70. Then, investigators will create the self-efficacy average by dividing the participant's score by the number of self-efficacy items (7). The composite will range from 1 to 10.

  Three weeks after survey 1

• Self-efficacy survey 3 score

  Investigators will ask all participants Likert-type scale questions related to perceived self-efficacy with conducting caregiving tasks. Each rating will range from 1 to 10, with higher ratings representing higher perceptions of confidence in conducting caregiving tasks. Investigators will create the composite self-efficacy score by summing the scores from the participant's 7 self-efficacy items with a range of 7 to 70. Then, investigators will create the self-efficacy average by dividing the participant's score by the number of self-efficacy items (7). The composite will range from 1 to 10.

  Three weeks after survey 2

• Intentions survey 1 score

  Investigators will ask all participants Likert-type scale questions related to intentions of conducting caregiving tasks. Each rating will range from 1 to 10, with higher ratings representing higher intentions to conduct caregiving tasks. Investigators will create the composite intention score by summing the scores from the participant's 5 intention items with a range of 5 to 50. Then, investigators will create the intentions average by dividing the participant's composite score by the number of intention items (5). The average will range from 1 to 10.

  Survey 1 (baseline)

• Intentions survey 2 score

  Investigators will ask all participants Likert-type scale questions related to intentions of conducting caregiving tasks. Each rating will range from 1 to 10, with higher ratings representing higher intentions to conduct caregiving tasks. Investigators will create the composite intention score by summing the scores from the participant's 5 intention items with a range of 5 to 50. Then, investigators will create the intentions average by dividing the participant's composite score by the number of intention items (5). The average will range from 1 to 10.

  Three weeks after survey 1

• Intentions survey 3 score

  Investigators will ask all participants Likert-type scale questions related to intentions of conducting caregiving tasks. Each rating will range from 1 to 10, with higher ratings representing higher intentions to conduct caregiving tasks. Investigators will create the composite intention score by summing the scores from the participant's 5 intention items with a range of 5 to 50. Then, investigators will create the intentions average by dividing the participant's composite score by the number of intention items (5). The average will range from 1 to 10.

  Three weeks after survey 2

• Health survey 1

  Investigators will ask all participants four questions from the BRFSS 2021 core section 1: health status and core section 2: health days to assess general health, physical health, mental health, and interference with daily activities.

  Survey 1 (baseline)

• Health survey 2

  Investigators will ask all participants four questions from the BRFSS 2021 core section 1: health status and core section 2: health days to assess general health, physical health, mental health, and interference with daily activities.

  Three weeks after survey 1

• Health survey 3

  Investigators will ask all participants four questions from the BRFSS 2021 core section 1: health status and core section 2: health days to assess general health, physical health, mental health, and interference with daily activities.

  Three weeks after survey 2

Secondary Outcomes (1)

• Satisfaction - survey 2

  Three weeks after survey 1

Other Outcomes (14)

• Change in declarative knowledge scores from survey 1 to survey 2

  From baseline through survey 2, average 3 weeks

• Change in declarative knowledge scores from survey 1 to survey 3

  From baseline through survey 3, average 6 weeks

• Change in procedural knowledge scores from survey 1 to survey 2

  From baseline through survey 2, average 3 weeks

Study Arms (2)

Treatment

EXPERIMENTAL

Education and support by IN-HOME trained CHWs and use of the IN-HOME toolbox app

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

Control

ACTIVE COMPARATOR

Support by CHWs trained in other topic area to provide support "as usual" defined as general health education for the control group participants

Other: Supplying Useful Perimenopause Through Post-menopause Online Resources and Tools (SUPPORT)

Interventions

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

The IN-HOME CHW training is an eight-lesson online course delivered via live webinar sessions and asynchronously via the KDHRC CHW Virtual Academy. IN-HOME trained CHWs will provide support via three virtual sessions (phone, text, video call) to male caregivers over three weeks.

Treatment

Supplying Useful Perimenopause Through Post-menopause Online Resources and Tools (SUPPORT) OTHER

Lessons 1-4 for SUPPORT course; multi-module SUPPORT online training

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must identify as male.
• Must be at least 18 years old.
• Must be a caregiver (defined as providing care for an older adult who is ≥65 years of age).
• Must live in the United States.
• Must have access to a smartphone.

You may not qualify if:

• \- None

Sponsors & Collaborators

• KDH Research & Communication: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (1)

KDH Research & Communication

Atlanta, Georgia, 30309, United States

RECRUITING

MeSH Terms

Conditions

Behavior

Interventions

Palliative Care

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Nicole I Wanty, MA

  KDH Research & Communication

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kristen D Holtz, PhD

CONTACT

404-395-8711; kholtz@kdhrc.com

Nicole I Wanty, MA

CONTACT

715-360-0790; nwanty@kdhrc.com

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: July 9, 2026
• First Posted: July 15, 2026
• Study Start: June 19, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): November 15, 2026
• Last Updated: July 16, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Time Frame: Public use data will be submitted to OpenICPSR within 12 months of final data analysis by the project team.
• Access Criteria: Public use data: Upon approval by the data repository, KDHRC will share de-identified survey data on openICPSR. OpenICPSR will inform KDHRC of how many parties have downloaded the IN-HOME data, and users downloading openICPSR data agree: 1) To not use the datasets for investigation of specific research subjects, except when identification is authorized in writing by ICPSR; and 2) To make no use of the identity of any research subject discovered inadvertently, and to advise ICPSR of any such discovery."8 Access to data on openICPSR is free. Restricted data: Alchemer will collect restricted data, including IP addresses and geographic location of the participant when completing the surveys. KDHRC will also collect demographic information from participants, such as age, race, ethnicity, education, years as a caregiver, caregiving experience, geographic location, and technology use experience. These restricted data will be kept separate from the public use data, described above.

Locations

US (1)