Future Planning and Well-Being for Individuals With Intellectual Disabilities and Family Caregivers

Northwell Health

Status: Enrolling

Conditions: Intellectual Disability

Treatments: Behavioral: Map Our Life; Behavioral: Attention Control

Study type: Interventional

Funder types: Other

Identifiers

NCT06065527

23-0381

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,050 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,050 participants in 2 patient groups, including a placebo group

Enhanced usual care and Map Our Life

Active Comparator group

Description:

Participants will be introduced to Map Our Life, by research staff. In accordance to the Preparation for Future Care Model, PYL: (1) introduces users to long-term care (LTC) related choices (care expectation); (2) assesses the unique caregiving needs of the care recipient (awareness); (3) educates the users on locally and nationally available home-based resources (information gathering); (4) makes choices about LTC preferences (decision-making), and (5) shares those choices with others (concrete planning).This process is associated with informed and value-based decisions that fit the preferences of the care recipient and increased well-being according to the theory of proactive coping, which states that preparation for future stressors improves the ability to cope in real-time.

Treatment:

Behavioral: Map Our Life

Enhanced usual care and Attention Control

Placebo Comparator group

Description:

In this arm, caregivers will be referred to a website containing information from "Disability and Health Information for Family Caregivers". The content in the attention control is from CDC-sponsored websites that promote healthy activities and behaviors targeting people with disabilities and their family caregivers. Additionally, the content leads users to CDC-sponsored "Caregiving" webpages which assist families in developing care plans. All content is available in English and Spanish.

Treatment:

Behavioral: Attention Control