Intervention to Help Orient Men to Excel (IN-HOME) Phase II Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18+
SponsorKDH Research & Communication
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Intervention to Help Orient Men to Excel (IN-HOME)
BehavioralThe 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 interventionLessons 1-4 for SUPPORT course; multi-module SUPPORT online training
Treatment groups
360 Participants
are divided into 2 treatment groupsGroup A: TreatmentExperimental treatment 1 intervention
Group B: ControlActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Survey 1 (baseline)2
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.
Time frame
Three weeks after survey 13
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.
Time frame
Three weeks after survey 24
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.
Time frame
Survey 1 (baseline)Secondary outcomes
1
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.
Time frame
Three weeks after survey 1Other outcomes
1
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.
Time frame
From baseline through survey 2, average 3 weeks2
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.
Time frame
From baseline through survey 3, average 6 weeks3
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.
Time frame
From baseline through survey 2, average 3 weeks4
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.
Time frame
From baseline through survey 3, average 6 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
KDH Research & Communication
Lead sponsor
National Institute on Minority Health and Health Disparities (NIMHD)
Collaborator
Source ClinicalTrials.gov