Care Planning Tools for Intellectual Disability

Overseen By Sophia Jan, MD, MSHP

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Northwell Health

Disqualifiers: Non-English/Spanish speakers, No device access, Under 10, others

Compensation: Varies

Number of Visits: 1

Duration: 18 months

1050 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assist individuals with intellectual or developmental disabilities and their family caregivers in enhancing long-term care planning. It compares a web-based tool called Map Our Life, which aids users in making informed care decisions, with traditional case management tools. One group of participants will use Map Our Life, while the other group will receive information from CDC-sponsored websites. Family caregivers who speak English or Spanish, have internet access, and care for individuals with disabilities living in the community are ideal candidates for this trial. As an unphased trial, this study allows participants to contribute to innovative care planning solutions that could benefit many families.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that these care planning tools are safe for individuals with intellectual disabilities?

Research shows that online tools like "Map Our Life" are generally easy for people to use and assist individuals with disabilities in planning their future care. Previous studies have not reported any negative effects from using "Map Our Life." This trial focuses on the tool's effectiveness rather than safety.

The trial compares two methods: "Map Our Life" and a website featuring information from the CDC. Both methods are safe and aim to support families by providing useful information for planning long-term care. Participants can feel confident that these tools are designed to be both safe and helpful. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the "Map Our Life" care planning tool because it goes beyond traditional resources by actively involving caregivers in future planning for individuals with intellectual disabilities. Unlike typical treatments that primarily offer information or immediate care solutions, this tool helps caregivers make informed, value-based decisions by guiding them through long-term care choices and planning. This proactive approach aligns with the theory of proactive coping, aiming to improve real-time coping skills and overall well-being for both caregivers and care recipients.

What evidence suggests that this trial's tools could be effective for improving long-term care planning for individuals with intellectual disabilities?

Research has shown that the Map Our Life tool, available to participants in this trial, aids individuals with intellectual and developmental disabilities and their caregivers in planning for future care. This tool introduces users to long-term care options and helps them make informed choices based on their preferences. Early findings suggest it can enhance overall well-being by simplifying the process for families to understand and decide on care needs. Being prepared for future challenges makes them easier to manage when they arise. This approach is expected to improve social support, health, and quality of life for both individuals with disabilities and their families. Meanwhile, another group in this trial will receive Attention Control, which provides caregivers with information from CDC-sponsored websites to promote healthy activities and assist in developing care plans. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for family caregivers of individuals with intellectual and/or developmental disabilities who are over 10 years old, living in a community setting. Participants must speak English or Spanish and have access to a tablet, computer, or smartphone.

Inclusion Criteria

Access to a tablet, computer, or smartphone

I can speak English or Spanish.

This criterion applies to family members who take care of people with intellectual and/or developmental disabilities and live at home in the community.

Exclusion Criteria

I care for someone under 10 with intellectual and developmental disabilities.

Does not have access to a tablet, computer, or smartphone

I speak a language that is not English or Spanish.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in either the Map Our Life intervention or the attention control website, alongside enhanced usual care, to improve long-term care planning and caregiver support.

18 months

Surveys at baseline, 1 month, 6 months, and 18 months

Follow-up

Participants are monitored for health behaviors and quality of life outcomes after the intervention period.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Attention Control
• Map Our Life

Trial Overview The study tests a web-based tool called Map Our Life aimed at improving long-term care planning when used alongside traditional case management services. It's compared to standard services plus an attention-control health promotion website.

How Is the Trial Designed?

Group I: Enhanced usual care and Map Our Life Active Control 1 Intervention

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.

Group II: Enhanced usual care and Attention Control Placebo Group 1 Intervention

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.

Who Is Running the Clinical Trial?

Northwell Health

Lead Sponsor

Trials

481

Recruited

470,000+

Children's Hospital of Philadelphia

Collaborator

Trials

749

Recruited

11,400,000+

Geisinger Health

Collaborator

Trials

3

Recruited

7,800+

Children's Hospital Medical Center, Cincinnati

Collaborator

Trials

844

Recruited

6,566,000+

Patient-Centered Outcomes Research Institute

Collaborator

Trials

592

Recruited

27,110,000+

Baylor College of Medicine

Collaborator

Trials

1,044

Recruited

6,031,000+

Christiana Care Health Services

Collaborator

Trials

118

Recruited

204,000+

Published Research Related to This Trial

Executive attention, which helps us manage our awareness and control our actions, develops early in life, starting with the ability to regulate distress during the first year.

Neuroimaging studies show that different functions of executive attention are linked to specific areas in the anterior cingulate, and this development is crucial for cognitive control and emotional regulation in children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Attention, self-regulation and consciousness. Posner, MI., Rothbart, MK.[2022]

The attention system is structured with distinct modules that manage how attention is expressed and controlled, with anterior cortex involved in control and posterior cortex in expression.

Recent advancements in the triangular circuit theory reveal two modes of attentional activity: a brief enhancement for selecting information and prolonged oscillations for maintaining attention, suggesting different neural pathways for each mode.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Attentional control: brief and prolonged. LaBerge, D.[2005]

The adapted Tower of London (ToL) test is a valid tool for assessing planning and problem-solving skills in adults with intellectual disabilities, showing strong correlations with independent living skills and dysexecutive behaviors.

The study highlights the importance of developing additional assessment tools that reflect everyday planning tasks to better evaluate executive functions in individuals with intellectual disabilities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adaptation and validation of the Tower of London test of planning and problem solving in people with intellectual disabilities. Masson, JD., Dagnan, D., Evans, J.[2022]

The NIH Toolbox Cognition Battery (NIHTB-CB) effectively detects cognitive development changes in individuals with intellectual disabilities, showing comparable or superior growth measurements compared to the Stanford-Binet Intelligence Scales in a study of 256 participants aged 6-27 years.

The NIHTB-CB demonstrated significant cognitive gains in various domains for individuals with other intellectual disabilities (OID) at younger ages, while those with fragile X syndrome (FXS) and Down syndrome (DS) showed delayed gains, indicating the tool's potential to track meaningful cognitive trajectories across different types of intellectual disabilities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sensitivity of the NIH Toolbox to Detect Cognitive Change in Individuals With Intellectual and Developmental Disability. Shields, RH., Kaat, A., Sansone, SM., et al.[2023]

Person-Centred Planning (PCP) shows a moderate positive impact on community participation and daily choice-making for individuals with intellectual disabilities, based on a review of 16 studies published between 1990 and 2014.

The overall evidence for PCP's effectiveness is limited and inconsistent, particularly regarding employment outcomes, indicating a need for more comprehensive studies to assess its clinical and cost-effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness of person-centred planning for people with intellectual disabilities: A systematic review. Ratti, V., Hassiotis, A., Crabtree, J., et al.[2018]

Adults with mild to moderate intellectual disability show more significant deficits in top-down attentional processing compared to bottom-up processing, particularly when using auditory or tactile cues, which are less effective than visual cues.

The study revealed altered history-driven processing in individuals with intellectual disability, evidenced by a reversed priming effect for immediate repetitions of the same cue type, highlighting the need for tailored cognitive training programs that consider these specific attentional deficits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Top-down, bottom-up, and history-driven processing of multisensory attentional cues in intellectual disability: An experimental study in virtual reality. Kim, J., Hwang, E., Shin, H., et al.[2022]

Attention is defined by three key functions: maintaining alertness, orienting to sensory stimuli, and selecting responses, each linked to distinct brain networks that develop from infancy to adulthood.

Deficits in these attention networks are associated with disorders like autism spectrum disorders and attention deficit hyperactivity disorder (ADHD), highlighting the importance of understanding attention development in these conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing attention in typical children related to disabilities. Posner, MI., Rothbart, MK., Ghassemzadeh, H.[2021]

The ANTI-Vea-UGR is a new, free, and publicly accessible tool designed to assess attentional networks and vigilance components, making it easy for researchers to collect and analyze data from diverse populations, including clinical patients and children.

This computerized task, lasting 32 minutes, allows for flexible adaptation of stimulus timing and procedures, supporting both laboratory and online assessments of attention and vigilance, which can help researchers gather data from larger sample sizes efficiently.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The ANTI-Vea-UGR Platform: A Free Online Resource to Measure Attentional Networks (Alertness, Orienting, and Executive Control) Functioning and Executive/Arousal Vigilance. Coll-Martín, T., Román-Caballero, R., Martínez-Caballero, MDR., et al.[2023]

Attention can be understood as a distinct organ system in the brain, consisting of three interrelated neural networks responsible for alertness, sensory orientation, and executive control.

The Attentional Network Test (ANT) has been developed to measure the efficiency of these attention networks and can also be used in genetic studies to explore the underlying mechanisms of attention-related disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Human attentional networks. Fan, J., Posner, M.[2004]

In a double-blind trial involving 76 children with intellectual and developmental disabilities (IDD), attention training did not show immediate effects post-training, but participants demonstrated significant improvements in numeracy skills at a 3-month follow-up.

While the attention training program may offer benefits for children with IDD, the modest improvements suggest that further research is needed to fully understand its clinical significance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of Attention Training on Academic Achievement, Executive Functioning, and Behavior: A Randomized Controlled Trial. Kirk, H., Gray, K., Ellis, K., et al.[2017]

A quality improvement project for adults with intellectual and developmental disabilities (IDD) highlighted the need for a structured transition-of-care plan to support clients during changes in their living or care situations.

The project demonstrated that using evidence-based methods and collaborative communication significantly improved clients' and guardians' understanding of the importance of future planning, as shown by positive survey results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transition-of-care planning: Preparing for the future care of the individual with intellectual and developmental disabilities. Tencza, M., Forsythe, L.[2021]

The Expanded Mental Control Test (EMCT) was evaluated in a study involving 248 participants, including elderly residents and neurologic patients, showing satisfactory reliability and a strong correlation with attention-related tasks.

Performance on the EMCT was influenced by education level but not by age or sex, suggesting it effectively measures cognitive function related to attention in diverse elderly populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The diagnostic value of tests for mental control]. Lindeboom, J., Koene, T., Matto, D.[2006]

The COG-D package, which uses visual 'Cognitive Daisies' to represent residents' cognitive strengths and weaknesses, aims to improve person-centred care in residential homes for older adults with dementia by helping staff make informed care decisions.

This study is a 24-month feasibility trial involving 8-10 care homes, assessing the implementation of COG-D and training for staff, with outcomes focused on recruitment rates, assessment completion, and training participation to inform future large-scale trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Cognitive Daisy (COG-D) for improving care for residents with dementia in care homes: protocol of a feasibility RCT. Pollux, PMJ., Surr, C., Cohen, J., et al.[2023]

Serious games have been shown to positively impact executive functions (EFs) such as planning, decision-making, and social cognition in adults with intellectual disabilities, based on a review of 10 studies published since 2015.

While improvements in EFs were observed, they were not statistically significant, indicating that further development and refinement of serious game interventions may be necessary to enhance their effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Serious Games for Executive Functions Training for Adults with Intellectual Disability: Overview. Shapoval, S., Gimeno-Santos, M., Mendez Zorrilla, A., et al.[2023]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/41032360/

Protocol of a Pragmatic Randomized Controlled Trial Participants are randomly assigned (1:1) to either the Map Our Life web-based LTC planning tool plus enhanced usual care or an attention control ...

2. northwell.edu northwell.edu/clinical-trials/23-0381

Map Our Life This study will compare the effectiveness of a web-based long-term care planning tool (Map Our Life) partnered with traditional case management services.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12530160/

Innovative Web-Based Future Planning and Well-Being for ... This protocol describes the design and methods of the Future Planning and Well-Being for Individuals with Intellectual Disabilities and Family Caregivers study, ...

4. pcori.org pcori.org/research-results/2022/comparing-effectiveness-web-based-future-planning-tool-attention-control-website-family-caregivers-individuals-intellectual-disabilities

Comparing the Effectiveness of A Web-Based Future ... This study compares the effectiveness of a web-based future planning tool to an attention control website among primary family caregivers of ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06065527

Future Planning and Well-Being for Individuals With ... 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 ...

6. ichgcp.net ichgcp.net/amp/clinical-trials-registry/NCT06065527

Map Our Life and Attention Control in Intellectual Disability - Clinical ... 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 ...

7. withpower.com withpower.com/trial/phase-intellectual-disability-9-2023-ce6f7

Care Planning Tools for Intellectual Disability 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 ...