IN-HOMEImpact du programme IN-HOME sur les connaissances, les compétences et la santé des aidants masculins
Cette étude vise à évaluer l'impact d'un cours À DOMICILE sur les connaissances, les compétences, la santé et les attitudes des aidants masculins envers les tâches de soins, en administrant des enquêtes avant et après le cours.
Intervention to Help Orient Men to Excel (IN-HOME)
+ Supplying Useful Perimenopause Through Post-menopause Online Resources and Tools (SUPPORT)
Autre étude
Résumé
Date de début de l'étude : 19 juin 2026
Date à laquelle le premier participant a commencé l'étude.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.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.360 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Autre
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Homme
Le sexe biologique des participants éligibles à s'inscrire.À partir de 18 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Critères
Plan de l'étude
Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.2 groupes d'intervention sont désignés dans cette étude
Cette étude ne comporte pas de groupe placebo.
Groupes de traitement
Groupe I
ExpérimentalGroupe II
Comparateur actifObjectifs de l'étude
Objectifs principaux
Objectifs secondaires
Centres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 1 site
KDH Research & Communication
Atlanta, United StatesOuvrir KDH Research & Communication dans Google Maps