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Recruiting NCT06065527

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

No phase Interventional Intellectual Disability

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Map Our Life, Attention Control.
Who it may be relevant to
Registry conditions: Intellectual Disability. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

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)
  • 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.]
Secondary outcome measures (5)
  • Quality of Life Outcomes - Caregiver self-efficacy [Time frame: Baseline, 1 month, 6 months and 18 months.]
  • Quality of Life Outcomes - IDD [Time frame: Baseline and 6 months]
  • Health Behaviors Outcomes - Problem-focused coping behaviors [Time frame: Baseline, 1 month,6 months and 18 months.]
  • Health Behaviors Outcomes - Caregiver long term care planning behaviors [Time frame: Baseline, 1 month,6 months and 18 months.]
  • Health Behaviors Outcomes - Caregiver long term care knowledge [Time frame: Baseline, 1 month, 6 months, and 18 months]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Health services research

Study locations

United States · 1 center
  • Cohen Children's Medical Center — New Hyde Park

Publications

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

Identifiers

NCT: NCT06065527 · 23-0381

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗