Clinical trial NCT06065527: Future Planning and Well-Being for Individuals With Intellectual Disabilities and Family Caregivers
Official title: Future Planning and Well-Being for Individuals With Intellectual Disabilities and Family Caregivers
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Intellectual Disability
Keywords: Caregiver
case management
Lead sponsor: Northwell Health
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
name: Baylor College of Medicine
name: Christiana Care Health Services
name: Children's Hospital of Philadelphia
name: Children's Hospital Medical Center, Cincinnati
name: Geisinger Health
First posted: 2023-10-04
Enrollment: 1050
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a multi-site, two-arm, pragmatic randomized controlled trial (RCT) of primary family caregivers of individuals with IDD. Family caregivers will be randomized 1:1 to one of 2 treatment arms described above. This is a non-blinded study because the nature of the intervention prevents participants from being blinded to their study arm.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study will compare the effectiveness of a web-based long-term care planning tool (Map Our Life) partnered with traditional case management services to traditional case management services partnered with an attention-control Centers for Disease Control and Prevention (CDC) sponsored website on health promotion for people with disabilities. The goal of this clinical trial is to promote long-term care (LTC) knowledge and planning among individuals with intellectual/developmental disabilities (IDD) and their family caregivers to improve social supports, health, and quality of life outcomes.

Detailed description: People with intellectual/developmental disabilities (IDD) experience alarmingly high rates of mortality, morbidity, and acute care utilization compared to those without an IDD, particularly during emergencies. Caregiver health and well-being is a determinant of health outcomes for people with an IDD. Yet, caregivers are aging and frequently experience high caregiver burden and poor well-being. Poor preparedness and planning lead to crises and harm, including emotional trauma, unsafe living conditions, unwanted emergent nursing home placements, and potential early mortality, for both people with an IDD and their family caregivers.

The goal of this study is to promote health emergency preparedness and long-term care (LTC) decision-making among individuals with intellectual/developmental disabilities (IDD) and their family caregivers to improve patient- and caregiver-reported health and quality of life outcomes. Through partnerships with adults with IDD, their families, IDD community organizations, and IDD services agencies, the investigators seek to conduct a randomized controlled trial comparing the effectiveness of Map Our Life - a web-based future planning intervention and enhanced usual care (EUC) - care coordination services vs. an attention control (AC) and EUC on health promotion for people with disabilities and their family caregivers. Aim 1 will compare the effectiveness of Map Our Life +EUC vs AC+EUC on family caregiver support and well-being at 1, 6, and 18 months. Aim 2 will examine the comparative effectiveness of Map Our Life +EUC vs. AC+EUC on planning behaviors and communicating future preferences for LTC planning, and its mediating effects on family caregiver support and well-being at 1, 6, and 18 months. Finally, aim 3 will identify how individual and caregiver need factors and access to services and supports moderate intervention treatment effects at 6 and 18 months from the perspective of the individual with IDD and separately from their caregiver.

We will conduct a national, multi-site, two-arm, randomized controlled trial (RCT) of primary family caregivers of individuals with IDD. A total of 1050 family caregivers will be randomized 1:1 to one of 2 treatment arms: (1) enhanced usual care plus a web-based future planning intervention, Map Our Life; and (2) attention control website plus EUC. Primary participants will be family caregivers of individuals with IDD who are at least 18 years old living in community settings recruited from stakeholder groups, Northwell Health (New York), Christiana Care Health System (Delaware), Baylor College of Medicine (Texas), Children's Hospital of Philadelphia (Pennsylvania), Cincinnati Children's Hospital Medical Center (Ohio), and Geisinger Health (Pennsylvania). Primary outcomes include caregiver burden and caregiver wellbeing. Secondary outcomes include adequacy and satisfaction with services and supports, well-being and planning choices of adult care recipient with IDD, and planning behaviors and communication of plans. Participants will complete surveys at the time of enrollment and at 1-, 6-, and 18- months post enrollment.

Eligibility criteria: Inclusion Criteria:

* Family caregivers of individuals with intellectual and/or developmental disabilities living in a community setting
* Ability to speak English or Spanish
* Access to a tablet, computer, or smartphone

Exclusion Criteria:

* Speaks a language other than English or Spanish
* Does not have access to a tablet, computer, or smartphone
* Caregivers who care for individuals with intellectual and developmental disabilities who are less than 10 years of age.
* Special populations such as: fetuses, prisoners, or other institutionalized individuals

Primary outcomes:
measure: Quality of Life Outcomes - Caregiver burden
timeFrame: Baseline, 1 month, 6 months and 18 months.
Secondary outcomes:
measure: Quality of Life Outcomes - Caregiver self-efficacy
timeFrame: Baseline, 1 month, 6 months and 18 months.
measure: Quality of Life Outcomes - IDD
timeFrame: Baseline and 6 months
measure: Health Behaviors Outcomes - Problem-focused coping behaviors
timeFrame: Baseline, 1 month,6 months and 18 months.
measure: Health Behaviors Outcomes - Caregiver long term care planning behaviors
timeFrame: Baseline, 1 month,6 months and 18 months.
measure: Health Behaviors Outcomes - Caregiver long term care knowledge
timeFrame: Baseline, 1 month, 6 months, and 18 months
Other outcomes:
Locations:
city: New Hyde Park
country: United States
facility: Cohen Children's Medical Center
state: New York
Study officials:
References:
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citation: Indicators | National Core Indicators. Accessed April 30, 2020. https://www.nationalcoreindicators.org/about/indicators/
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