Pilot Pragmatic Clinical Trial to Embed Tele-Savvy Into Health Care Systems
Condition: Alzheimer Disease; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurocognitive Disorders; Neurodegenerative Diseases; Mental Disorders
MeSH terms: Alzheimer Disease; Nervous System Diseases; Neurodegenerative Diseases; Brain Diseases; Central Nervous System Diseases; Tauopathies; Mental Disorders; Neurocognitive Disorders
Study type: Interventional

Summary: 
      This cluster randomized pragmatic clinical trial will test the effectiveness and feasibility
      of embedding the Tele-Savvy intervention, a psychoeducational program for family and other
      informal caregivers of older adults living in the community with Alzheimer's disease and
      related dementia (ADRD), in two health care systems/clinical sites: UConn Health in
      Farmington, Connecticut, and Emory Healthcare in Atlanta, Georgia.
    

Detailed description: 
      This cluster randomized pragmatic clinical trial will test the effectiveness and feasibility
      of embedding the Tele-Savvy intervention, a psychoeducational program for family and other
      informal caregivers of older adults living in the community with Alzheimer's disease and
      related dementia (ADRD), in two health care systems/clinical sites: UConn Health in
      Farmington, Connecticut, and Emory Healthcare in Atlanta, Georgia. A total of 100 caregivers,
      50 at each study site, will participate in this pilot study. At each site, 30 caregivers will
      be randomly assigned to receive the Tele-Savvy intervention, and 20 caregivers will be
      randomly assigned to receive the self-guided Caregiving During Crisis online program.

      All 100 caregivers will complete identical self-administered questionnaires to measure the
      caregiver-specific outcome measures in this pilot study. Outcome measures will include
      caregiver mastery (primary outcome), caregiver response to specific memory and behavioral
      problems, and caregiver stress. Also, we will employ process measures of participation and
      engagement in the interventions for caregivers in both arms of the trial, as well as
      implementation outcomes via surveys with clinicians and Information Technology staff at each
      of the two clinical sites responsible for programming electronic medical records to enable
      capture and storage of caregiver outcomes.
    

Intervention name(s): Tele-Savvy; Caregiving During Crisis (Educational Program)
Intervention type(s): Behavioral; Behavioral
Intervention description(s): A low-risk, psychoeducational, group-based intervention, is grounded in social learning and stress process theory and its main goal is to produce improved caregiver mastery over the symptom management skills commonly encountered when supervising and caring at home for an older adult living with ADRD. Over the 7-week program, there are synchronous and asynchronous activities each week. The synchronous portion includes weekly scheduled videoconferences (60-80 min) that serve as an online classroom in which facilitators lead lectures and discussions. Daily, caregivers access online 6- to 15-min prerecorded videos, each focused on one main learning objective. Caregivers can watch the lessons whenever and as often as they wish.; The attention control group will receive the self-guided Caregiving During Crisis program. Caregiving During Crisis is a fully online, asynchronous, professionally designed continuing education course aimed at developing the competency of informal caregivers of community-dwelling persons living with dementia to ensure the safety of that person and themselves during this time of the COVID-19 pandemic. The course, readily accessible by home computer or smartphone, describes methods of home infection control and prevention to create a Safe Home space, strategies for safely leaving and re-entering the home (e.g., to shop), additional strategies for safely allowing service personnel (e.g., home health aides or electricians) and select family members to enter the Safe Home space, and risk management strategies to frame decisions when/if COVID restrictions are relaxed or revoked.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Three Tele-Savvy programs, with 10 caregivers in each Tele-Savvy program cohort, will be held sequentially at each health care system site, for a total of 60 caregivers in 6 Tele-Savvy cohorts. Recruitment will occur in three waves, whereby caregivers will be randomly assigned at a 3:2 ratio to either Tele-Savvy or the attention control group until the first Tele-Savvy cohort is filled (first wave), followed by the same randomization procedure until the second and third Tele-Savvy cohorts are filled.
Masking: None (Open Label)
Primary purpose: Other