Intellectual DisabilityNCT06065527
Future Planning and Well-Being for Individuals With Intellectual Disabilities and Family Caregivers
A study testing Map Our Life in people with Intellectual Disability, run by Northwell Health at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intellectual Disability
- What is being tested?
- Map Our Life
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,050 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Dec 2023to 30 Apr 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Cohen Children's Medical Center
New Hyde Park, New York, 11040
About this study
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.
Read the 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.
- Conditions
- Intellectual Disability
- Being tested
- Map Our Life, Attention Control
- Keywords
- Caregiver, case management
- Medical subject headings
- Intellectual Disability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Map Our LifeBehavioural
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 ControlBehavioural
The control group will have access to a CDC Website, CDC Healthy Living with a Disability.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Attention Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 1 month, 6 months and 18 months.
Secondary outcomes (5)
Quality of Life Outcomes - Caregiver self-efficacy
The second outcome measure is self-efficacy as measured by the 5-item Respite Subscale of the Revised Scale for Caregiving Self-Efficacy, which has strong clinimetric properties and responsiveness. All questions start with the stem, "How confident are you that you can ask a friend or family member to stay with your loved one for…". An example is, "...a day when you need to see the doctor yourself?". Items are scored from 0 ("Cannot do at all") to 100 ("Certain can do"), for a total mean score ranging from 0 to 100.
Measured: Baseline, 1 month, 6 months and 18 months.
Quality of Life Outcomes - IDD
As part of an exploratory aim, the study will measure quality of life outcomes among affected individuals with intellectual disability using the World Health Organization Quality of Life Scale - Disability Modules (WHOQOL-Dis), a cross-cultural, multi-center instrument developed by the WHOQOL group for the assessment of quality of life in persons with disabilities. The scale was selected for its combination of specificity and validity among people with IDD and for its brevity and convenience.
Measured: Baseline and 6 months
Health Behaviors Outcomes - Problem-focused coping behaviors
This outcome is problem-focused coping behaviors, as measured by the 4-item active coping, 4-item planning, 4-item seeking of instrumental social support, and 4-item denial subscales of the Coping Orientation to Problems Experienced (COPE) inventory, a multi-dimensional coping inventory to assess responses to stress. Items ask participants what they usually do when confronting difficult or stressful events in their lives, and include statements such as "I make a plan of action".
Measured: Baseline, 1 month,6 months and 18 months.
Health Behaviors Outcomes - Caregiver long term care planning behaviors
This outcome focuses on long term care planning behaviors. This measure is adapted from the planning behaviors and communication of plans questionnaire used in the Plan Your Lifespan (PYL) randomized clinical trial of aging adults. Respondents answer on a 5-point Likert scale ranging from 1 ("Strongly disagree") to 5 ("Strongly agree"). Responses are summed creating a score ranging from 21 to 105, with higher scores indicating better planning and communication behavior.
Measured: Baseline, 1 month,6 months and 18 months.
Health Behaviors Outcomes - Caregiver long term care knowledge
This exploratory outcome will measure long term care knowledge, an enabling factor, measure by the Information and Planning Subdomain of the National Core Indicators (NCI) Family Surveys. Responses range from "Never" to "Always" and are summed based on the "Always" response.
Measured: Baseline, 1 month, 6 months, and 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2023
- Study start22 Dec 2023
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Intellectual DisabilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 1,050 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, Baylor College of Medicine, Christiana Care Health Services, Children's Hospital Medical Center, Cincinnati, Geisinger Health, Children's Hospital of Philadelphia
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06065527
- Sponsor's protocol ID
- 23-0381
- Status last verified
- Feb 2026
- First submitted
- 26 Sep 2023
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 7203086Schreiner 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.
PubMed 16517485Lindquist 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.
PubMed 28689855Lindquist 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.
PubMed 29091979Ramirez-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.
PubMed 32686545Rydzewska 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.
PubMed 30173164Kinnear 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.
PubMed 29431619Indicators | National Core Indicators. Accessed April 30, 2020. https://www.nationalcoreindicators.org/about/indicators/
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
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.
PubMed 20217246Steinway 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.
PubMed 41032360
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Future Planning and Well-Being for Individuals With Intellectual Disabilities and Family Caregivers
- ClinicalTrials.gov ID
- NCT06065527
- Acronym / sponsor ID
- 23-0381
- Conditions
- Intellectual Disability
- Keywords
- Caregiver, case management
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,050 participants (estimated)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, Baylor College of Medicine, Christiana Care Health Services, Children's Hospital Medical Center, Cincinnati, Geisinger Health, Children's Hospital of Philadelphia
- Study start
- 22 Dec 2023 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Apr 2029 (estimated)
- First posted
- 4 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Enhanced usual care and Map Our Life | Active comparator | Behavioral: Map Our LifeParticipants 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. |
| Enhanced usual care and Attention Control | Placebo comparator | Behavioral: Attention ControlIn 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 may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Map Our LifeThe 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. | Behavioural | Enhanced usual care and Map Our Life |
| Attention ControlThe control group will have access to a CDC Website, CDC Healthy Living with a Disability. | Behavioural | Enhanced usual care and Attention Control |
Primary outcome
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.
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
- Background: PubMed 7203086Zarit 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.
- Background: PubMed 16517485Schreiner 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.
- Background: PubMed 28689855Lindquist 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.
- Background: PubMed 29091979Lindquist 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.
- Background: PubMed 32686545Ramirez-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.
- Background: PubMed 30173164Rydzewska 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.
- Background: PubMed 29431619Kinnear 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.
- BackgroundIndicators | National Core Indicators. Accessed April 30, 2020. https://www.nationalcoreindicators.org/about/indicators/
- BackgroundCDC. 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: PubMed 20217246Power 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.
- Derived from this study: PubMed 41032360Steinway 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Map Our Life in people with Intellectual Disability, run by Northwell Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Life Outcomes - Caregiver burden (time frame: Baseline, 1 month, 6 months and 18 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06065527, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2026.