Clinical trial NCT04621448: Moving Together: An Online Group Movement Program for People Living With Memory Loss and Caregivers
Official title: Extending Independence and Quality of Life for People With Alzheimer's Disease or Dementia Through Telehealth Program Delivery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alzheimer Disease
Dementia
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2020-11-09
Enrollment: 224
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Delayed-start control group
Primary purpose: TREATMENT

Brief summary: To determine whether Moving Together improves quality of life in people with memory loss (PWML) and caregivers (CG) by performing a randomized, controlled trial (RCT) with a waitlist control group in 224 dyads.

Detailed 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) 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.

Eligibility criteria: Inclusion Criteria:

* People with memory loss (PWML):

  * U.S. resident;
  * English language fluency;
  * diagnosis of Alzheimer's disease or other dementia; mild severity, assessed using the Quick Dementia Rating System.
* Caregivers (CG):

  * U.S. resident;
  * English language fluency;
  * Primary caregiver for PWML;
  * own one or more devices that can be used to participate in two-way livestreaming video classes (e.g., smart phone/tablet + TV, laptop or desktop with webcam, smart TV);
  * willing and able to participate in two-way livestreaming group movement classes with person with PWML.

Exclusion Criteria:

* Age \< 18 years;
* primarily use wheelchair inside home;
* limited life expectancy (e.g., enrolled in hospice, meta-static cancer);
* physical limitations that could affect ability to participate (e.g., difficulty sitting for 1 hour, chronic pain, vertigo);
* severe visual impairment (e.g., unable to observe instructor's movements on screen);
* severe hearing impairment (e.g., unable to hear instructor's requests);
* behavioral or psychiatric issues that could be disruptive in group setting (e.g., history of physical or verbal abuse, schizophrenia, bipolar disorder, substance abuse);
* unable to provide consent/assent;
* planning to travel for \>1 week during initial 12-week study period.

Primary outcomes:
measure: Quality of Life - Change (Quality of Life in Alzheimer's Disease Scale, QOL-AD)
timeFrame: Baseline to 12-weeks
measure: Caregiver Physical Health - Change (Short Form Health Survey [SF-12] Physical Composite Score [PCS])
timeFrame: Baseline to 12-weeks
measure: Caregiver Mental Health - Change (Short Form - 12 [SF-12] Mental Composite Score [MCS])
timeFrame: Baseline to 12 weeks
Secondary outcomes:
measure: Well-being - Change (Neuro-QOL v1.0 Positive Affect and Well-Being Short Form)
timeFrame: Baseline to 12-weeks
measure: Social Isolation - Change (Patient-Reported Outcomes Measurement Information System v2.0 Social Isolation Scale)
timeFrame: Baseline to 12-weeks
measure: Mobility - Change (Neuro-QOL Short Form V1.0 - Lower Extremity Function - Mobility)
timeFrame: Baseline to 12-weeks
measure: Cognitive Function - Change (Telephone Montreal Cognitive Assessment, t-MoCA)
timeFrame: Baseline to 12-weeks
measure: Caregiver Healthy Days - Change (Healthy Days Core Module)
timeFrame: Baseline to 12-weeks
measure: Caregiver Self-efficacy - Change (Gain in Alzheimer Care INstrument (GAIN))
timeFrame: Baseline to 12-weeks
measure: Caregiver Burden - Change (Zarit Burden Interview, 6-item Version)
timeFrame: Baseline to 12-weeks
measure: Caregiver Social Isolation - Change (PROMIS v2.0 Social Isolation Scale)
timeFrame: Baseline to 12-weeks
measure: Caregiver Self-regulation - Change (Abbreviated Multidimensional Assessment of Interoceptive Awareness-2 (MAIA) Self-regulation Subscale)
timeFrame: Change from baseline to 12-weeks
measure: Caregiver Positive Affect (Positive States of Mind)
timeFrame: Baseline to 12-weeks
measure: Caregiver Sleep - Change (Symptom Checklist, 3 Items)
timeFrame: Baseline to 12-weeks
measure: People With Memory Loss (PWML) Sleep - Change (Symptom Checklist, 3 Items)
timeFrame: Baseline to 12-weeks
measure: People With Memory Loss (PWML) Mobility - Change (Neuro-QOL Short Form V1.0 - Lower Extremity Function - Mobility)
timeFrame: Baseline to 12-weeks
measure: People With Memory Loss (PWML) Cognitive Function - Change (Cognitive Function Instrument - Modified)
timeFrame: Baseline to 12-weeks
Other outcomes:
measure: Caregiver (CG) Falls
timeFrame: Baseline to 12 weeks
measure: People With Memory Loss (PWML) Falls
timeFrame: Baseline to 12 weeks
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Deborah Barnes, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Barnes DE, Mehling W, Wu E, Beristianos M, Yaffe K, Skultety K, Chesney MA. Preventing loss of independence through exercise (PLIE): a pilot clinical trial in older adults with dementia. PLoS One. 2015 Feb 11;10(2):e0113367. doi: 10.1371/journal.pone.0113367. eCollection 2015.
citation: Casey JJ, Harrison KL, Ventura MI, Mehling W, Barnes DE. An integrative group movement program for people with dementia and care partners together (Paired PLIE): initial process evaluation. Aging Ment Health. 2020 Jun;24(6):971-977. doi: 10.1080/13607863.2018.1553142. Epub 2019 Feb 12.
citation: Wu E, Barnes DE, Ackerman SL, Lee J, Chesney M, Mehling WE. Preventing Loss of Independence through Exercise (PLIE): qualitative analysis of a clinical trial in older adults with dementia. Aging Ment Health. 2015;19(4):353-62. doi: 10.1080/13607863.2014.935290. Epub 2014 Jul 14.
citation: Nicosia FM, Lee JA, Chesney MA, Benjamin C, Lee AN, Mehling W, Sudore RL, Barnes DE. Adaptation of an In-Person Mind-Body Movement Program for People with Cognitive Impairment or Dementia and Care Partners for Online Delivery: Feasibility, Satisfaction and Participant-Reported Outcomes. Glob Adv Integr Med Health. 2023 Sep 21;12:27536130231202989. doi: 10.1177/27536130231202989. eCollection 2023 Jan-Dec.
citation: Barnes DE, Jiang F, Benjamin C, Lee JA, Sudore RL, Mehling WE, Chesney MA, Chao LL, Nicosia FM. Livestream, group movement program for people living with cognitive impairment and care partners: A randomized clinical trial. Alzheimers Dement (N Y). 2024 May 2;10(2):e12467. doi: 10.1002/trc2.12467. eCollection 2024 Apr-Jun.