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

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.

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.

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