Goal Attainment Scaling (GAS) Sub-Study

NCT06484426 | Completed

• 1 other identifier: LIFE-DSR-GAS DS-AD
• Study Type: observational
• Target: 46
• Locations: 1 country
• Sites: 5

Brief Summary

This is an optional sub-study that will enroll participants from LIFE-DSR parent protocol. The aim is to assess change over 16 months in individuals with Down syndrome through individualized goals set by their caregivers. This sub-study also aims to assess the feasibility of Goal Attainment Scaling in the DS-AD population.

Conditions

Alzheimer's Disease in Down Syndrome

Keywords

Down Syndrome; Alzheimer's Disease

Outcome Measures

Primary Outcomes (1)

• Goal Attainment Scaling (GAS)

  Patient centered outcome measure aiming to assess change in individuals with Down syndrome through individualized goals set by their caregivers. This sub-study also aims to assess the feasibility of Goal Attainment Scaling in the DS-AD population. GoalNav® DS-AD Instrument This is a web-based platform developed by Ardea Outcomes with a DS-AD menu of 58 symptoms/challenges developed in collaboration with LuMind IDSC Foundation. This instrument is intended to track pre-dementia and dementia symptoms over time, including behaviors and other challenges common in adults with DS-AD. The goal scale is a 5-point scale. Minimum value is 1 maximum value is 5 No indicators of what higher or lower scores mean.

  16 months

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Males and females, aged 35 and older, with a diagnosis of DS. Must be enrolled in the LIFE-DSR (the parent study to the GAS sub-study)

You may qualify if:

• The participant with DS and caregiver must be currently enrolled in the LIFE-DSR parent protocol.
• The participant with DS must be age 35 years or older.
• Both the participant with DS, or LAR, and their caregiver must be able to understand and be willing to sign written informed consent.
• In the opinion of the Investigator, a participant's caregiver must have frequent interaction with the participant on a regular basis, agree to participate in clinic and remote visits, be able to provide accurate responses to questions about the participant with DS, and be capable of facilitating participation in the study visits.
• Participant with DS and caregiver must be capable of reliably completing all study assessments at each time-point.
• The caregiver must be able to converse in English.

You may not qualify if:

• Unable to complete trial procedures or adhere to the schedule of study assessments, in the opinion of the site PI.

Sponsors & Collaborators

• LuMind IDSC Foundation: lead
• Ardea Outcomes Inc.: collaborator
• Pentara: collaborator

Study Sites (5)

University of California, San Diego

San Diego, California, 920347, United States

Location

Advocate Health

Park Ridge, Illinois, 60068, United States

Location

Kennedy Krieger Institute

Baltimore, Maryland, 21205, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02129, United States

Location

Case Western Reserve University School of Medicine

Cleveland, Ohio, 44106-6090, United States

Location

MeSH Terms

Conditions

Down Syndrome; Alzheimer Disease

Condition Hierarchy (Ancestors)

Intellectual Disability; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Chromosome Disorders; Genetic Diseases, Inborn; Dementia; Brain Diseases; Central Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2024
• First Posted: July 3, 2024
• Study Start: June 30, 2021
• Primary Completion: February 29, 2024
• Study Completion: February 29, 2024
• Last Updated: July 3, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)