iCare4Me Transitions

Study Overview
=================
Brief Summary
-----------------
The goal of this randomized controlled trial is to examine the effect of a virtual face-to-face health coach intervention to improve self-care among caregivers of hospitalized older adults during care transitions compared to web-based resource information alone to determine the effectiveness of each intervention. The main questions it aims to answer are: compare the efficacy of the virtual health coaching intervention vs. web-based information alone in improving self-care in caregivers of hospitalized community-dwelling older adults with multiple chronic conditions (MCCs) who transition from hospital to home, compare outcomes among Black/African American and White caregivers who receive the intervention vs. digital health information alone, and explore the estimated the cost of the interventions and acute care resource use among patients of caregivers who received virtual intervention vs. digital health information alone. Participants who enroll will agree to enroll will: be randomly assigned to either the health information group or the health coaching intervention plus health information group for six months, and be asked to complete a baseline interview, a check-in call at one month post-hospital discharge, and two follow-up interviews at 3- and 6-months after enrollment. Researchers will compare the two groups of caregivers on the following outcomes: self-care, caregiver self-efficacy (aka confidence), coping, stress, and health status.

Official Title
-----------------
Improving Care Transitions and Self-care Among Informal Caregivers of Hospitalized Older Adults Through Digital Tools

Conditions
-----------------
Caregiver Stress

Intervention / Treatment
-----------------
* Other: Digital Health Information
* Behavioral: Virtual Health Coach for You


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Informal caregiver providing care at least 8 hours/week to the hospitalized older adult (age 65 or older) Reporting poor self-care on screening (Health Self-Care Neglect scale score greater than or equal to 2) Willing to use technology (e.g., computer, smartphone, iPad/tablet) Able to complete the protocol, e.g., adequate vision and hearing English speaking Exclusion Criteria: Cognitive deficits in orientation and/or recall (Six Item Screener score less than 3) Participation in another similar support or care transition trial Untreated major psychiatric illness (Use of anti-anxiety or anti-depressant medicines is acceptable)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control group<br>Digital health information is delivered through a website tailored with care transitions and self-care information for all participants over the 6-month study. | Other: Digital Health Information<br>* Digital health information websites.<br>|
| Experimental: Intervention Group<br>Study participants in the intervention group will receive 10-session virtual health coaching intervention sessions delivered over 6 months. | Other: Digital Health Information<br>* Digital health information websites.<br>Behavioral: Virtual Health Coach for You<br>* Study participants in the intervention group will receive 10-session virtual health coaching intervention session delivered over 6 months with the goal of improving caregiver self-care and coping, decreasing stress, and improving the hospital-to-home experience The 10 sessions are on average 60 minutes and cover the following topics: care transitions, caregiving demand, self-care, and coping.<br>* Other names: ViCCY;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-Care Inventory | The Self-Care Inventory (SCI) measures self-care maintenance, monitoring, management, and self-efficacy. Each subscale is standardized on a 0-100 point scale. Higher scores indicate better self-care. | Collected at: enrollment, 3- and 6-months after enrollment | 
| Health Self-Care Neglect | This scale captures the level of self-care neglect, with higher scores indicating greater neglect. | Collected at: enrollment, 3- and 6-months after enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perceived Stress Scale | The perceived stress scale has 10 items rated on a 5-point scale rating perceptions of stress. | Collected at: enrollment, 3- and 6-months after enrollment | 
| Brief COPE | This tool is designed to assess the varying coping strategies used by individuals in response to stress. | Collected at: enrollment, 3- and 6-months after enrollment | 
| Caregiver Self-Care Self-Efficacy Scale | This scale measures caregiving self-efficacy. | Collected at: enrollment, 3- and 6-months after enrollment | 
| Preparedness for Caregiving Scale | This scale measures how prepared caregivers feel to provide support for their loved ones. | Collected at: enrollment, 3- and 6-months after enrollment | 
| Quality of the relationship | This scale measures giving and receiving support. | Collected at: enrollment, 3- and 6-months after enrollment | 
| RAND Medical Outcomes Study Short Form (SF-36) | This scale measures overall mental and physical health. | Collected at: enrollment, 3- and 6-months after enrollment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Care Transitions, Older Adult, Health Coaching, Virtual, Self-Care, Coping