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

Intervention to Help Orient Men to Excel (IN-HOME) Phase II - Randomized Controlled Trial (RCT)

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.

Study Overview

• Status: Recruiting
• Conditions: Attitude; Caregivers; Health; Knowledge; Self-Efficacy; Community Health Workers; Intentions
• Intervention / Treatment: Behavioral: Intervention to Help Orient Men to Excel (IN-HOME); Other: Supplying Useful Perimenopause Through Post-menopause Online Resources and Tools (SUPPORT)

Detailed Description

The investigators will use a randomized, two-group design to evaluate the Intervention to Help Orient Men to Excel (IN-HOME) course and explore the following research questions: 1) To what extent does male caregiver receipt of outreach from IN-HOME-trained CHWs (a) increase their knowledge, skills, and self-efficacy about the importance of caregiving and accessing caregiving resources; managing their and their family member's health and financial needs; and navigating the health care system and (b) improve their general, physical, and mental health and reduce interference with daily tasks due to health-related issues? and 2) To what extent do caregivers report satisfaction, comfort accessing CHW support, and perceived benefit of the toolbox app?

KDH Research & Communication (KDHRC) will contract with 60 CHWs who will receive the IN-HOME training or alternative training (SUPPORT, which focuses on menopause content). IN-HOME content was developed in conjunction with subject matter experts and the intended audience to ensure the IN-HOME course includes accurate material and reflects the specific needs of CHWs providing outreach male caregivers. Trained CHWs will be assigned five to six male caregivers to provide outreach to over a three-week period. Male caregivers, the human subject participants in the study, will complete three surveys.

Principal Investigator Nicole Wanty (KDHRC), with input from subject matter experts, 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.

KDHRC contracted with a national recruitment company to recruit participants. The recruitment company implements the IRB-approved eligibility screener with men in their national database to identify eligible caregivers. Eligible caregivers receive a link to the online consent form programmed in a secure online platform. Consented participants will be randomized to the treatment or control groups and complete Survey 1. The study will include up to 360 male caregivers nationwide (180 treatment group, 180 control group). KDHRC will remind participants that participation in the study is completely voluntary.

Treatment group participants. After completing Survey 1, each treatment group participant will be assigned to an IN-HOME-trained CHW. The email will also include a link for the participant to download the toolbox app. Participants can communicate with their CHW via the toolbox app or directly. Over the three-week intervention period, the participants will have up to three sessions with their CHW. After the intervention period, the treatment participants will complete Survey 2. Then, three weeks later the treatment participants will complete Survey 3.

Control group participants. The control group will use a lagged design where the control participants will receive no intervention, then they will receive the control intervention. After completing Survey 1, the control group will receive no intervention for the first three weeks. Then, the control participants will complete Survey 2 and be introduced to their CHWs. Control participants will receive CHW support "as usual", defined as general health education from the control group CHWs over a three-week period before completing Survey 3. After completing Survey 3, KDHRC will share IN-HOME resources from the toolbox app with control participants.

Participant responses to survey measures will be linked using non-personal identifiers. KDHRC will download and export the data from the online survey platform into encrypted Excel files and import the raw data into STATA. The study team will match the surveys using the non-personal identifiers and conduct analyses to test the effect of IN-HOME-trained CHW support on changes in caregivers' knowledge, skills, attitudes, self-efficacy, and health.

• Study Type: Interventional
• Enrollment (Estimated): 360
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kristen D Holtz, PhD; Phone Number: 404-395-8711; Email: kholtz@kdhrc.com
• Study Contact Backup: Name: Nicole I Wanty, MA; Phone Number: 715-360-0790; Email: nwanty@kdhrc.com

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30309
      • Recruiting
      • KDH Research & Communication
      • Contact: Kristen D Holtz, PhD; Phone Number: 404-395-8711; Email: kholtz@kdhrc.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

- None

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment; 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); 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.
Active Comparator: Control; 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); Lessons 1-4 for SUPPORT course; multi-module SUPPORT online training

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Satisfaction - survey 2	Investigators will ask only the treatment group participants Likert-type scale questions related to their satisfaction with IN-HOME trained CHW support and the IN-HOME toolbox app. Each rating will range from 1 to 10, with higher scores representing higher satisfaction. Investigators will sum the scores from the participant's 4 satisfaction items for a satisfaction composite score ranging from 4 to 40. Investigators will then create the satisfaction average by dividing by the total number of satisfaction items (4). Scores range from 1 to 10, with higher scores meaning better satisfaction.	Three weeks after survey 1

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in declarative knowledge scores from survey 1 to survey 2	At both survey 1 and survey 2, investigators created a composite knowledge score for each participant ranging from 0 to 100. A score of 0 means a participant got zero questions correct while a score of 100 means a participant got all questions correct. Investigators will then subtract survey 1 composite from survey 2 composite. Higher scores mean higher gains from baseline to survey 2.	From baseline through survey 2, average 3 weeks
Change in declarative knowledge scores from survey 1 to survey 3	At both survey 1 and survey 3, investigators created a composite knowledge score for each participant ranging from 0 to 100. A score of 0 means a participant got zero questions correct while a score of 100 means a participant got all questions correct. Investigators will then subtract survey 1 composite from survey 3 composite. Higher scores mean higher gains from baseline to survey 3.	From baseline through survey 3, average 6 weeks
Change in procedural knowledge scores from survey 1 to survey 2	At both survey 1 and survey 2, investigators created a composite knowledge score for each participant ranging from 0 to 100. A score of 0 means a participant got zero questions correct while a score of 100 means a participant got all questions correct. Investigators will then subtract survey 1 composite from survey 2 composite. Higher scores mean higher gains from baseline to survey 2.	From baseline through survey 2, average 3 weeks
Change in procedural knowledge scores from survey 1 to survey 3	At both survey 1 and survey 3, investigators created a composite knowledge score for each participant ranging from 0 to 100. A score of 0 means a participant got zero questions correct while a score of 100 means a participant got all questions correct. Investigators will then subtract survey composite from survey 3 composite. Higher scores mean higher gains from baseline to survey 3.	From baseline through survey 3, average 6 weeks
Change in skills scores from survey 1 to survey 2	At both survey 1 and survey 2, investigators created a composite skills score for each participant ranging from 9 to 90. Higher ratings represent higher perceived experience. Investigators will then subtract survey 1 composite from survey 2 composite. Higher scores mean higher gains from baseline to survey 2.	From baseline through survey 2, average 3 weeks
Change in skills scores from survey 1 to survey 3	At both survey 1 and survey 3, investigators created a composite skills score for each participant ranging from 9 to 90. Higher ratings represent higher perceived experience. Investigators will then subtract survey 1 composite from survey 3 composite. Higher scores mean higher gains from baseline to survey 3.	From baseline through survey 3, average 6 weeks
Change in positive attitude scores from survey 1 to survey 2	At both survey 1 and survey 2, investigators created a composite attitude score for each participant ranging from 4 to 40. Higher ratings represent higher positive attitudes. Investigators will then subtract survey 1 composite from survey 2 composite. Higher scores mean higher gains from baseline to survey 2.	From baseline through survey 2, average 3 weeks
Change in positive attitude scores from survey 1 to survey 3	At both survey 1 and survey 3, investigators created a composite attitude score for each participant ranging from 4 to 40. Higher ratings represent higher positive attitudes. Investigators will then subtract survey 1 composite from survey 3 composite. Higher scores mean higher gains from baseline to survey 3.	From baseline through survey 3, average 6 weeks
Change in self-efficacy scores from survey 1 to survey 2	At both survey 1 and survey 2, investigators created a composite self-efficacy score for each participant ranging from 7 to 70. Higher ratings represent higher self-efficacy. Investigators will then subtract survey 1 composite from survey 2 composite. Higher scores mean higher gains from baseline to survey 2.	From baseline through survey 2, average 3 weeks
Change in self-efficacy scores from survey 1 to survey 3	At both survey 1 and survey 3, investigators created a composite self-efficacy score for each participant ranging from 7 to 70. Higher ratings represent higher self-efficacy. Investigators will then subtract survey 1 composite from survey 3 composite. Higher scores mean higher gains from baseline to survey 3.	From baseline through survey 3, average 6 weeks
Change in intention scores from survey 1 to survey 2	At both survey 1 and survey 2, investigators created a composite intention score for each participant ranging from 5 to 50. Higher ratings represent higher intentions. Investigators will then subtract survey 1 composite from survey 2 composite. Higher scores mean higher gains from baseline to survey 2.	From baseline through survey 2, average 3 weeks
Change in intention scores from survey 1 to survey 3	At both survey 1 and survey 3, investigators created a composite intention score for each participant ranging from 5 to 50. Higher ratings represent higher intentions. Investigators will then subtract survey 1 composite from survey 3composite. Higher scores mean higher gains from baseline to survey 3.	From baseline through survey 3, average 6 weeks
Change in health from survey 1 to survey 2	At both survey 1 and survey 2, participants responded to 4 questions on health status and days of not good physical health, mental health, and interference with daily activities. For each question investigators will calculate change from survey 1 to survey 2 and create a dichotomous variable (positive change or negative change). For example, a participant who reports 14 "not good" physical health days at survey 1 and 9 "not good" physical health days at survey 2 would be categorized as positive change.	From baseline through survey 2, average 3 weeks
Change in health from survey 1 to survey 3	At both survey 1 and survey 3, participants responded to 4 questions on health status and days of not good physical health, mental health, and interference with daily activities. For each question investigators will calculate change from survey 1 to survey 3 and create a dichotomous variable (positive change or negative change). For example, a participant who reports 14 "not good" physical health days at survey 1 and 4 "not good" physical health days at survey 3 would be categorized as positive change.	From baseline through survey 3, average 6 weeks

Collaborators and Investigators

• Sponsor: KDH Research & Communication
• Collaborators: National Institute on Minority Health and Health Disparities (NIMHD)
• Investigators: Principal Investigator: Nicole I Wanty, MA, KDH Research & Communication

Study record dates

Study Major Dates

• Study Start (Actual): June 19, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): November 15, 2026

Study Registration Dates

• First Submitted: July 9, 2026
• First Submitted That Met QC Criteria: July 9, 2026
• First Posted (Actual): July 15, 2026

Study Record Updates

• Last Update Posted (Actual): July 15, 2026
• Last Update Submitted That Met QC Criteria: July 9, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Health; Male; Caregivers
• Additional Relevant MeSH Terms: Behavior; Therapeutics; Patient Care; Health Services; Health Care Facilities Workforce and Services; Palliative Care
• Other Study ID Numbers: 2026-05-03; R44MD018249-03 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: KDHRC will share the manipulated, de-identified survey data on openICPSR
• IPD Sharing Time Frame: Public use data will be submitted to OpenICPSR within 12 months of final data analysis by the project team.

IPD Sharing 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No