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

NCT06065527 | Recruiting

• 1 other identifier: 23-0381
• Study Type: interventional
• Target: 1,050
• Locations: 1 country
• Sites: 1

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

Keywords

Caregiver; case management

Outcome Measures

Primary Outcomes (1)

• Quality of Life Outcomes - Caregiver burden

  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.

  Baseline, 1 month, 6 months and 18 months.

Secondary Outcomes (5)

• Quality of Life Outcomes - Caregiver self-efficacy

  Baseline, 1 month, 6 months and 18 months.

• Quality of Life Outcomes - IDD

  Baseline and 6 months

• Health Behaviors Outcomes - Problem-focused coping behaviors

  Baseline, 1 month,6 months and 18 months.

• Health Behaviors Outcomes - Caregiver long term care planning behaviors

  Baseline, 1 month,6 months and 18 months.

• Health Behaviors Outcomes - Caregiver long term care knowledge

  Baseline, 1 month, 6 months, and 18 months

Study Arms (2)

Enhanced usual care and Map Our Life

ACTIVE COMPARATOR

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.

Behavioral: Map Our Life

Enhanced usual care and Attention Control

PLACEBO COMPARATOR

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.

Behavioral: Attention Control

Interventions

Map Our Life BEHAVIORAL

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.

Enhanced usual care and Map Our Life

Attention Control BEHAVIORAL

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

Enhanced usual care and Attention Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwell Health: lead
• Patient-Centered Outcomes Research Institute: collaborator
• Baylor College of Medicine: collaborator
• Christiana Care Health Services: collaborator
• Children's Hospital of Philadelphia: collaborator
• Children's Hospital Medical Center, Cincinnati: collaborator
• Geisinger Health: collaborator

Study Sites (1)

Cohen Children's Medical Center

New Hyde Park, New York, 11040, United States

RECRUITING

Related Publications (11)

• Zarit SH, Reever KE, Bach-Peterson J. Relatives of the impaired elderly: correlates of feelings of burden. Gerontologist. 1980 Dec;20(6):649-55. doi: 10.1093/geront/20.6.649. No abstract available.

  PMID: 7203086 BACKGROUND

• Schreiner AS, Morimoto T, Arai Y, Zarit S. Assessing family caregiver's mental health using a statistically derived cut-off score for the Zarit Burden Interview. Aging Ment Health. 2006 Mar;10(2):107-11. doi: 10.1080/13607860500312142.

  PMID: 16517485 BACKGROUND

• Lindquist LA, Ramirez-Zohfeld V, Sunkara PD, Forcucci C, Campbell DS, Mitzen P, Ciolino JD, Gregory D, Kricke G, Cameron KA. PlanYourLifeSpan.org - an intervention to help seniors make choices for their fourth quarter of life: Results from the randomized clinical trial. Patient Educ Couns. 2017 Nov;100(11):1996-2004. doi: 10.1016/j.pec.2017.06.028. Epub 2017 Jun 27.

  PMID: 28689855 BACKGROUND

• Lindquist LA, Ramirez-Zohfeld V, Sunkara PD, Forcucci C, Campbell DS, Mitzen P, Ciolino JD, Kricke G, Seltzer A, Ramirez AV, Cameron KA. Helping Seniors Plan for Posthospital Discharge Needs Before a Hospitalization Occurs: Results from the Randomized Control Trial of PlanYourLifespan.org. J Hosp Med. 2017 Nov;12(11):911-917. doi: 10.12788/jhm.2798. Epub 2017 Aug 23.

  PMID: 29091979 BACKGROUND

• Ramirez-Zohfeld V, Seltzer A, Ramirez A, Muhammad R, Lindquist LA. Longitudinal Follow-Up of Long-Term Care Planning Using PlanYourLifespan.org. J Appl Gerontol. 2021 May;40(5):536-540. doi: 10.1177/0733464820943066. Epub 2020 Jul 19.

  PMID: 32686545 BACKGROUND

• Rydzewska E, Hughes-McCormack LA, Gillberg C, Henderson A, MacIntyre C, Rintoul J, Cooper SA. Prevalence of long-term health conditions in adults with autism: observational study of a whole country population. BMJ Open. 2018 Sep 1;8(8):e023945. doi: 10.1136/bmjopen-2018-023945.

  PMID: 30173164 BACKGROUND

• Kinnear D, Morrison J, Allan L, Henderson A, Smiley E, Cooper SA. Prevalence of physical conditions and multimorbidity in a cohort of adults with intellectual disabilities with and without Down syndrome: cross-sectional study. BMJ Open. 2018 Feb 5;8(2):e018292. doi: 10.1136/bmjopen-2017-018292.

  PMID: 29431619 BACKGROUND

• Indicators | National Core Indicators. Accessed April 30, 2020. https://www.nationalcoreindicators.org/about/indicators/

  BACKGROUND

• CDC. Disability & Health Information for Family Caregivers | CDC. Centers for Disease Control and Prevention. Published October 28, 2019. Accessed January 11, 2022. https://www.cdc.gov/ncbddd/disabilityandhealth/family.html

  BACKGROUND

• Power MJ, Green AM; WHOQOL-Dis Group. Development of the WHOQOL disabilities module. Qual Life Res. 2010 May;19(4):571-84. doi: 10.1007/s11136-010-9616-6. Epub 2010 Mar 9.

  PMID: 20217246 BACKGROUND

• Steinway C, Wright C, Kwak S, Teng O, Seide A, Berens J, Woodward J, Riddle I, Davis T, Greenberg A, Szalda D, Shults J, Cerise J, Jan S. Innovative Web-Based Future Planning and Well-Being for Caregivers of Individuals With Intellectual and Developmental Disabilities: Protocol of a Pragmatic Randomized Controlled Trial. JMIR Res Protoc. 2025 Oct 1;14:e77184. doi: 10.2196/77184.

  PMID: 41032360 DERIVED

MeSH Terms

Conditions

Intellectual Disability

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders

Central Study Contacts

Sophia Jan, MD, MSHP

CONTACT

(516) 465-4377; sjan1@northwell.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Masking will not occur because it is not a blinded study.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 26, 2023
• First Posted: October 4, 2023
• Study Start: December 22, 2023
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): April 30, 2029
• Last Updated: January 3, 2024

Record last verified: 2023-12

Locations

US (1)