This study is accepting new patients by invitation only

Preventing Loss of Independence Through Exercise in Community Living Centers

a study on Dementia Cognitive Dysfunction Pain Neurocognitive Disorder

Summary

Eligibility
for people ages 18 years and up (full criteria)
Healthy Volunteers
healthy people welcome
Location
at San Francisco, California
Dates
study started
study ends around
Principal Investigator
by Francesca M Nicosia, PhD MALinda L. Chao, PhD BS
Headshot of Francesca M Nicosia
Francesca M Nicosia
Headshot of Linda L. Chao
Linda L. Chao

Description

Summary

Approximately 40,000 older Veterans with complex care needs receive long-term care in VA Community Living Centers (CLCs). Many CLC staff have limited specialized training to engage Veterans with dementia. Preventing Loss of Independence through Exercise (PLIÉ) is a gentle, multi-domain, group movement program for people with cognitive impairment that has shown physical, cognitive, social, and emotional benefits. This effectiveness-implementation study will train interprofessional CLC staff via a remote program and evaluate PLIÉ-CLC delivered as part of routine clinical care at up to 12 VA CLCs. We will assess resident physical function (primary outcome) and secondary outcomes (e.g., social engagement, mood, cognition, behaviors, falls, pain, and quality of life), as well as person-centered care practices, staff engagement, burnout, and workplace climate, and the sustainment of the program after external facilitation ends.

Official Title

Preventing Loss of Independence Through Exercise in Community Living Centers: An Effectiveness-Implementation Trial

Details

Background & Significance: Many Veterans in CLCs have comorbid neurocognitive, mental health, and physical impairments; staff often lack specialized training for optimal engagement. PLIÉ-CLC adapts a structured, mind-body movement program for CLC residents (including those using wheelchairs) and provides an experiential staff training model. Prior VA work developed and piloted a remote PLIÉ staff training program with >50 staff trained across multiple sites.

Design: A Type 2 Hybrid Effectiveness-Implementation study using a Stepped Wedge Cluster Randomized Trial (SW-CRT) across up to 12 CLCs. Phases: Pre-implementation planning & champion training; Implementation (remote staff training + staff-delivered PLIÉ groups); Sustainment. Delivery of PLIÉ-CLC classes during Implementation/Sustainment is considered usual clinical care; research activities include staff training and evaluation measures.

Outcomes & Timepoints: Primary: change in physical function from MDS 3.0 Section G. Secondary: mood, cognition, behaviors, falls, pain, social engagement (0, 3, 6 months), resident/staff PLIÉ Experience (residents at 3 months; staff at 3, 6, 12 months), plus exploratory incontinence (MDS). Implementation outcomes include reach, adoption, fidelity, maintenance (e.g., sustainment threshold ≥1 group/week), (0, 3, 6, 12) .

Risks & Precautions: Minimal risk comparable to routine physical activity programs; potential exercise-related injuries (e.g., strain/soreness, joint pain, falls) mitigated via trained staff instructors and graded movement progressions; responding to questionnaires may be uncomfortable, with procedures to minimize discomfort including voluntary nature of completing specific items.

Keywords

Dementia, Cognitive Dysfunction, health-related quality of life, Social Participation, Accidental Falls, Pain, Movement, Behavior, neurocognitive disorder, nursing homes, implementation science, Neurocognitive Disorders, Preventing Loss of Independence through Exercise (PLIE), PLIE-CLC

Eligibility

You can join if…

Open to people ages 18 years and up

VA Community Living Centers (CLCs) internal facilitators/champions Inclusion criteria:

  • Full-time CLC clinical staff member (including registered nurses, certified nursing assistants, nurse aids, recreation therapists, occupational therapists, physical therapists, mental health professionals or others)
  • Willingness to facilitate PLIÉ-CLC implementation at their site
  • Willingness to participate in initial and debrief site visit

PLIÉ-CLC staff instructors Inclusion criteria:

  • CLC clinical staff member or volunteer interested in learning to lead PLIÉ-CLC classes
  • Willingness to participate in remote training process
  • Willingness to lead PLIÉ classes locally, including tracking attendance and other process measures
  • Willingness to participate in initial and debrief site visits and biweekly check-ins

Veteran residents of Community Living Centers (CLCs) Inclusion criteria:

Identification and random selection process for Veteran resident participants in PLIÉ-CLC staff training program: For each internal facilitator/champion, the research team will create a list of residents who meet the following eligibility criteria:

  • Cognitive impairment (defined as documented diagnosis of ADRD or other neurocognitive disorder and/or clinician judgment)
  • Long-stay resident (anticipated length of stay 120 days)
  • Ability to sit in a standard chair or wheelchair unaided for a 1-hour class
  • English language proficiency
  • Current clinical care relationship (defined as documentation of one or more clinical encounters or care provided to the resident during the previous 2 months).

VA Community Living Centers (CLCs) directors Inclusion criteria:

  • Recommended by VHA leader as likely to be 'early adopter' based on successful implementation of program such as STAR-VA OR
  • g based on patient population (primarily palliative care or long stay maintenance/custodial care

You CAN'T join if...

VA Community Living Centers (CLCs) internal facilitators/champions exclusion Criteria:

  • Planning to leave the facility in next 12 months

PLIÉ-CLC staff instructors exclusion criteria:

  • Planning to leave the facility in next 12 months

Veteran residents of Community Living Centers (CLCs) exclusion Criteria:

  • Comatose
  • Bedbound
  • Severe hearing, visual or communication challenges (i.e., unable to hear, see or understand well enough to participate)
  • Limited life expectancy
  • Lack of ability to assent to study procedures and does not have an LAR

VA Community Living Centers (CLCs) Directors exclusion criteria:

  • Lack of willingness or interest in participating

Location

  • San Francisco VA Medical Center, San Francisco, CA
    San Francisco California 94121-1563 United States

Lead Scientists at UCSF

  • Francesca M Nicosia, PhD MA
    As a medical anthropologist, health services researcher, and certified yoga therapist, my research focuses on improving pain, function, and quality of life outcomes for older adults, women, and veterans through nonpharmacologic and complementary and integrative health (CIH) interventions and care models.
  • Linda L. Chao, PhD BS
    Linda Chao, PhD, is a Professor in the Department of Radiology and Biomedical Imaging and in the Department of Psychiatry at the University of California, San Francisco. Dr. Chao obtained her BS in Biological Science from the University of California, Davis in 1991, and she completed her PhD studies in Neuroscience from UCD in 1996.

Details

Status
accepting new patients by invitation only
Start Date
Completion Date
(estimated)
Sponsor
VA Office of Research and Development
ID
NCT06972004
Study Type
Interventional
Participants
Expecting 288 study participants
Last Updated