Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Alzheimer Disease
  • Dementia
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Sequential AssignmentIntervention Model Description: Delayed-start control groupMasking: Single (Outcomes Assessor)Masking Description: Dyads will be enrolled and randomized in blocks of 16 (n=8 immediate start, n=8 waitlist). The randomization sequence will be generated in advance by Dr. Barnes' team using a random number generator and will be maintained in a secure location. Individuals who collect or analyze outcome data will be unaware of the randomization sequence and blinded to group assignment.Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

The investigators will perform an RCT with a 12-week delayed start control group in 224 dyads of PWMLs and CGs. The primary outcome in PWML will be self-rated quality of life (Quality of Life in Alzheimer's Disease, QOL-AD). Secondary outcomes will include: a) self-reported emotional well-being; b) ...

The investigators will perform an RCT with a 12-week delayed start control group in 224 dyads of PWMLs and CGs. The primary outcome in PWML will be self-rated quality of life (Quality of Life in Alzheimer's Disease, QOL-AD). Secondary outcomes will include: a) self-reported emotional well-being; b) self-reported social isolation; c) self-reported mobility; and d) directly assess cognitive performance. In CGs, the primary outcome will be self-rated quality of life (SF-12). Secondary outcomes in CGs will include: a) healthy days; b) self-efficacy; c) burden; d) social isolation; e) ability to self-regulate; f) positive affect; and g) sleep quality. In addition, the investigators will ask CGs to report sleep quality, mobility, and cognitive function for PWML. Additional exploratory outcomes will include health services utilization (hospitalizations, emergency department visits) and falls. In addition to the RCT, the investigators propose to compare health utilization outcomes in study participants to a matched 'no contact' comparison sample of patients with dementia diagnoses who receive care in the University of California San Francisco (UCSF) Health system.

Tracking Information

NCT #
NCT04621448
Collaborators
National Institute on Aging (NIA)
Investigators
Principal Investigator: Deborah Barnes, PhD, MPH University of California, San Francisco