Intervention to Help Orient Men to Excel (IN-HOME) Phase II - Randomized Controlled Trial (RCT)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 360
- Locations
- 1
- Primary Endpoint
- Declarative knowledge survey 1 score
Study Overview
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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
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
- Not provided
Arms & Interventions
Treatment
Education and support by IN-HOME trained CHWs and use of the IN-HOME toolbox app
Intervention: Intervention to Help Orient Men to Excel (IN-HOME) (Behavioral)
Control
Support by CHWs trained in other topic area to provide support "as usual" defined as general health education for the control group participants
Intervention: Supplying Useful Perimenopause Through Post-menopause Online Resources and Tools (SUPPORT) (Other)
Outcomes
Primary Outcomes
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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
- Satisfaction - survey 2(Three weeks after survey 1)