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NCT Number: NCT07704060

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

KDH Research & Communication

Atlanta, Georgia, 30309, United States

Location status: Recruiting

Location contact

Kristen D Holtz, PhD

CONTACT

[email protected]

404-395-8711

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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

Other

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

Primary outcomes

  1. Declarative knowledge survey 1 score

    Time frame: Survey 1 (baseline)

    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.

  2. Declarative knowledge survey 2 score

    Time frame: Three weeks after survey 1

    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.

  3. Declarative knowledge survey 3 score

    Time frame: Three weeks after survey 2

    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.

  4. Procedural knowledge survey 1 score

    Time frame: Survey 1 (baseline)

    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.

  5. Procedural knowledge survey 2 score

    Time frame: Three weeks after survey 1

    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.

  6. Procedural knowledge survey 3 score

    Time frame: Three weeks after survey 2

    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.

  7. Skills survey 1 score

    Time frame: Survey 1 (baseline)

    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.

  8. Skills survey 2 score

    Time frame: Three weeks after survey 1

    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.

  9. Skills survey 3 score

    Time frame: Three weeks after survey 2

    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.

  10. Positive attitudes survey 1 score

    Time frame: Survey 1 (baseline)

    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.

  11. Positive attitudes survey 2 score

    Time frame: Three weeks after survey 1

    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.

  12. Positive attitudes survey 3 score

    Time frame: Three weeks after survey 2

    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.

  13. Self-efficacy survey 1 score

    Time frame: Survey 1 (baseline)

    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.

  14. Self-efficacy survey 2 score

    Time frame: Three weeks after survey 1

    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.

  15. Self-efficacy survey 3 score

    Time frame: Three weeks after survey 2

    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.

  16. Intentions survey 1 score

    Time frame: Survey 1 (baseline)

    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.

  17. Intentions survey 2 score

    Time frame: Three weeks after survey 1

    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.

  18. Intentions survey 3 score

    Time frame: Three weeks after survey 2

    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.

  19. Health survey 1

    Time frame: Survey 1 (baseline)

    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.

  20. Health survey 2

    Time frame: Three weeks after 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.

  21. Health survey 3

    Time frame: Three weeks after 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.

Secondary outcomes

  1. Satisfaction - survey 2

    Time frame: Three weeks after survey 1

    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.

Other outcomes

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

    Time frame: From baseline through survey 2, average 3 weeks

    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.

  2. Change in declarative knowledge scores from survey 1 to survey 3

    Time frame: From baseline through survey 3, average 6 weeks

    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.

  3. Change in procedural knowledge scores from survey 1 to survey 2

    Time frame: From baseline through survey 2, average 3 weeks

    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.

  4. Change in procedural knowledge scores from survey 1 to survey 3

    Time frame: From baseline through survey 3, average 6 weeks

    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.

  5. Change in skills scores from survey 1 to survey 2

    Time frame: From baseline through survey 2, average 3 weeks

    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.

  6. Change in skills scores from survey 1 to survey 3

    Time frame: From baseline through survey 3, average 6 weeks

    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.

  7. Change in positive attitude scores from survey 1 to survey 2

    Time frame: From baseline through survey 2, average 3 weeks

    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.

  8. Change in positive attitude scores from survey 1 to survey 3

    Time frame: From baseline through survey 3, average 6 weeks

    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.

  9. Change in self-efficacy scores from survey 1 to survey 2

    Time frame: From baseline through survey 2, average 3 weeks

    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.

  10. Change in self-efficacy scores from survey 1 to survey 3

    Time frame: From baseline through survey 3, average 6 weeks

    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.

  11. Change in intention scores from survey 1 to survey 2

    Time frame: From baseline through survey 2, average 3 weeks

    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.

  12. Change in intention scores from survey 1 to survey 3

    Time frame: From baseline through survey 3, average 6 weeks

    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.

  13. Change in health from survey 1 to survey 2

    Time frame: From baseline through survey 2, average 3 weeks

    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.

  14. Change in health from survey 1 to survey 3

    Time frame: From baseline through survey 3, average 6 weeks

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Kristen D Holtz, PhD

CONTACT

[email protected]

404-395-8711

Nicole I Wanty, MA

CONTACT

[email protected]

715-360-0790

Sponsors and collaborators

Lead sponsor

KDH Research & Communication

Industry

Collaborators

  • National Institute on Minority Health and Health Disparities (NIMHD)

Registry information

Official study title

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

Acronym: IN-HOME

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jul 15, 2026
Registry last updated
Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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