NCT06065527 · Northwell Health
Future Planning and Well-Being for Individuals With Intellectual Disabilities and Family Caregivers
What this study is 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.
View original scientific description
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.
Interventions
BEHAVIORAL
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.
BEHAVIORAL
Attention Control
The control group will have access to a CDC Website, CDC Healthy Living with a Disability.
Primary outcome measures
Quality of Life Outcomes - Caregiver burden
Time frame: Baseline, 1 month, 6 months and 18 months.
The primary outcome measure is caregiver burden as measured by the Zarit Burden Interview (ZBI). The ZBI is the most commonly used measure of distress among caregivers, and has good clinimetric properties and responsiveness. Responses to each item in the scale are on a 5-point scale ranging from 0 ("Never") to 4("Nearly Always"), with a total score ranging from 0 to 88.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- New Hyde Park, New York
Collaborators
Patient-Centered Outcomes Research Institute, Baylor College of Medicine, Christiana Care Health Services, Children's Hospital of Philadelphia, Children's Hospital Medical Center, Cincinnati, Geisinger Health
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 3, 2024 · Source of record for eligibility and locations