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Trial record 1 of 1 for:    NCT03960476
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Decision Making and Implementation of Aging-in-Place/Long Term Care Plans Among Older Adults

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ClinicalTrials.gov Identifier: NCT03960476
Recruitment Status : Recruiting
First Posted : May 23, 2019
Last Update Posted : February 17, 2020
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Lee Lindquist, Northwestern University

Tracking Information
First Submitted Date  ICMJE May 16, 2019
First Posted Date  ICMJE May 23, 2019
Last Update Posted Date February 17, 2020
Actual Study Start Date  ICMJE January 13, 2020
Estimated Primary Completion Date August 30, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 20, 2019)
Change in long-term care plan decision-making [ Time Frame: Change from baseline decision-making at 36 months. Will also be measured every six months, up to 42 months. ]
Change in participant's long-term care plan decision-making from baseline to 36 months post-baseline. Decision-making will be measured as a binary ('yes', 'no') outcome at each time-point.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 20, 2019)
  • Participant utilization of long-term care services [ Time Frame: Baseline and every six months, up to 42 months ]
    Participant utilization of long-term care services such as in-home caregivers as measured by the Resource Use Inventory (Sano M, Zhu CW, Whitehouse PJ, et al. ADCS Prevention Instrument Project: pharmacoeconomics: assessing health-related resource use among healthy elderly. Alzheimer Dis Assoc Disord. 2006;20(4 Suppl 3):S191-S202. doi:10.1097/01.wad.0000213875.63171.87).
  • Number of participants that implement any of their long-term care plans [ Time Frame: Baseline and every six months, up to 42 months ]
    The number of participants that implement any long-term care plans they have set. This will be measured as a binary ('yes', 'no') outcome at each time-point.
  • Participant long-term care goal concordance [ Time Frame: Baseline and every six months, up to 42 months ]
    Assess whether participant's long-term care plans are carried out in accordance to their goals. This will be measured as a binary ('yes', 'no') outcome at each time-point.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Decision Making and Implementation of Aging-in-Place/Long Term Care Plans Among Older Adults
Official Title  ICMJE Decision Making and Implementation of Aging-in-Place/Long Term Care Plans Among Older Adults
Brief Summary This study seeks to better understand how older adult aging-in-place/long term care decision making and implementation is impacted by age-related changes (e.g. cognition, health literacy, chronic conditions), social influences (e.g. caregivers/supporters), and environmental factors.
Detailed Description Subjects who are part of the NIA-funded LitCog study will be given access to PlanYourLifespan.org, a web-based decision-making and planning tool. Participants will be followed for up to 42 months to examine the mediating/moderating factors involved in decision-making, timing of decision implementation, and goal concordance. Findings have the potential to inform healthcare providers, caregivers, health/long term care insurers, area agencies on aging, and older adults nationally in supporting aging-in-place decisions and services use.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
All study participants receive access to the web-based study intervention, PlanYourLifespan.org.
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE
  • Alzheimer Disease
  • Mild Cognitive Impairment
Intervention  ICMJE Behavioral: PlanYourLifespan.org
The study intervention is a web-based planning tool, PlanYourLifespan.org
Study Arms  ICMJE Experimental: Access to Web-Based Intervention
All study participants will be given access to the web-based study intervention, PlanYourLifespan.org.
Intervention: Behavioral: PlanYourLifespan.org
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 20, 2019)
700
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 29, 2024
Estimated Primary Completion Date August 30, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Current participant in the LitCog Trial [R01AG03611]
  • English-speaking
  • Community-dwelling
  • Currently use a computer or tablet with internet

Exclusion Criteria:

  • Previous participation in the Advanced Planning for Home Services study [IH-12-11-4259]
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 55 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Vanessa Ramirez-Zohfeld, MPH 312-503-3916 vanessa-ramirez-0@northwestern.edu
Contact: Lee A Lindquist, MD, MBA, MPH 312-503-5558 LAL425@northwestern.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03960476
Other Study ID Numbers  ICMJE R01AG058777( U.S. NIH Grant/Contract )
1R01AG058777-01A1 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Lee Lindquist, Northwestern University
Study Sponsor  ICMJE Northwestern University
Collaborators  ICMJE National Institute on Aging (NIA)
Investigators  ICMJE Not Provided
PRS Account Northwestern University
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP