Recruiting

Observational Study

Sponsor:

Northwell Health

Code:

NCT06065527

Conditions

Intellectual Disability

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Map Our Life

Attention Control

Study Details

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.

Conditions

Intellectual Disability

Study ID

NCT06065527

Start date

Dec 22, 2023

Status verified date

Dec, 2023

Completion date

Apr 30, 2029

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

1050 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

active comparator: Enhanced usual care and Map Our Life

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.

placebo comparator: Enhanced usual care and Attention Control

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.

Interventions

Map Our Life

The intervention takes participants through the process of planning using the Preparation for Future Care Model stages: care expectation, awareness, information gathering, decision making, and concrete planning. The intervention has 8 modules: (1) Letter of Intent for Your Loved One, (2) Caregiver Support and Well-Being, (3) Medical Decision Making for Your Loved One, (4) Daily Routines and Medical Management, (5) Medicaid Waiver for Your Loved One, (6) Financial Planning for Your Loved One, (7) Emergency Planning for Your Loved One, and (8) Managing Jobs, Day Programs, and Transportation. Map Our Life takes users - the caregiver alongside the individual with intellectual disability - through the stages of planning in each of the 8 modules until a concrete care plan is developed. The last component of the intervention is that this Care Plan is subsequently saved and shared with others such as care managers, clinicians, friends or family members.

Attention Control

The control group will have access to a CDC Website, CDC Healthy Living with a Disability.

Primary outcome measure

  • Quality of Life Outcomes - Caregiver burden [ Time Frame: Baseline, 1 month, 6 months and 18 months. ]

Central Contacts and Locations

Central contacts

Sophia Jan, MD, MSHP

(516) 465-4377sjan1@northwell.edu

Locations

Cohen Children's Medical Center

Recruiting

New Hyde Park, New York, United States, 11040

Contacts

Sophia Jan, MD, MSHP

516-465-5308sjan1@northwell.edu

More Information

Sponsor

Northwell Health

Last update posted

Jan 3, 2024

Last verified

Dec, 2023

Keywords

  • Caregiver
  • case management

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Northwell Health on 2024-01-03.