- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04621448
Moving Together: An Online Group Movement Program for People Living With Memory Loss and Caregivers
Extending Independence and Quality of Life for People With Alzheimer's Disease or Dementia Through Telehealth Program Delivery
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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California
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San Francisco, California, United States, 94143
- University of California, San Francisco
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Immediate Start
The Immediate Start group will participate in the 12-week Moving Together program after completing the baseline assessment.
Moving Together is a gentle, live-streaming, group movement program designed specifically for people with memory loss (PWML) and caregivers (CG) to do together.
It is based on the in-person Preventing Loss of Independence through Exercise (PLIÉ) and Paired PLIÉ programs.
The program combines physical movements to help maintain daily function with mindful body awareness exercises and social interactions to provide a comprehensive, multi-domain program.
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Two-way livestreaming virtual group classes will be offered for 1 hour, 2 days/week for 12 weeks to all participants. Classes will be led by a trained instructor who will demonstrate all movements and will provide brief explanations for the goals of movements. Consistent with the in-person program, classes will focus on the 7 guiding principles of Moving Together:
Other Names:
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Experimental: Delayed Start
A Delayed Start group will be encouraged to continue with their usual daily activities during the first 12 weeks of the study and will begin the Moving Together program after completing the mid-point assessment.
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Two-way livestreaming virtual group classes will be offered for 1 hour, 2 days/week for 12 weeks to all participants. Classes will be led by a trained instructor who will demonstrate all movements and will provide brief explanations for the goals of movements. Consistent with the in-person program, classes will focus on the 7 guiding principles of Moving Together:
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quality of life - change (Quality of Life in Alzheimer's Disease Scale, QOL-AD)
Time Frame: Baseline to 12-weeks
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The QOL-AD is a standard quality of life measure that has been validated for people with cognitive impairment.
Scores may range from 0-52, with higher scores reflecting better quality of life.
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Baseline to 12-weeks
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Caregiver Health - change (Short Form Health Survey (SF-12))
Time Frame: Baseline to 12-weeks
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The Short Form Health Survey (SF-12) is a 12-item questionnaire that was developed as a shorter alternative to the SF-36 Health Survey (SF-36).
It consists of a subset of 12 items from the SF-36 covering the same eight domains of health outcomes and generates two summary scores: the Physical and Mental Health Composite Scores (PCS, MCS).
Scores may range from 0-100, with higher scores reflecting better levels of health.
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Baseline to 12-weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Well-being - change (Neuro-QOL v1.0 Positive Affect and Well-Being Short Form)
Time Frame: Baseline to 12-weeks
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The Neuro-QOL v1.0 Positive Affect and Well-Being Short Form includes 9 items (e.g.
sense of well-being, feeling hopeful, life was satisfying, etc.) with 5-point responses from never (1) to always (5).
Scores range from 0-40 with higher scores indicating increased mobility.
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Baseline to 12-weeks
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Social isolation - change (Patient-Reported Outcomes Measurement Information System v2.0 social isolation scale)
Time Frame: Baseline to 12-weeks
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The Patient-Reported Outcomes Measurement Information System v2.0 social isolation scale consists of 4 items (feeling left out, people barely know me, feeling isolated, people are around but not with me) that are rated as 1 (never), 2 (rarely), 3 (sometimes), 4 (usually), or 5 (always).
Scores range from 0-20 with higher scores indicating less perceived social isolation.
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Baseline to 12-weeks
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Mobility - change (Neuro-QOL Short Form V1.0 - Lower Extremity Function - Mobility)
Time Frame: Baseline to 12-weeks
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The (Neuro-QOL Short Form v1.0 -- Lower Extremity Function -- Mobility), which includes 8 items for functional mobility (getting on and off the toilet, getting in and out of a car, getting out of bed into a chair).
Responses are rated on a 5-point Likert scale: 1( Without any difficult), 2 (With a little difficulty), 3 (With some difficulty), 4 (With much difficulty), 5 (Unable to do).
Scores may range from 0-40 with higher scores indicating increased mobility.
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Baseline to 12-weeks
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Cognitive function - change (telephone Montreal Cognitive Assessment, t-MoCA)
Time Frame: Baseline to 12-weeks
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The t-MoCA is extracted from the original face-to-face MoCA and uses items not requiring the use of a pencil and paper or visual stimulus.
Scores may range from 0-22 with higher scores indicating higher cognitive function.
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Baseline to 12-weeks
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Caregiver Healthy Days - change (Healthy Days Core Module)
Time Frame: Baseline to 12-weeks
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The Healthy Days Core Modules includes 3 questions about the number of days during the past 30 days that physical or mental health was not good or poor physical or mental health kept from doing usual activities.
Scores range from 0-18 with lower scores indicating higher physical or mental health.
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Baseline to 12-weeks
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Caregiver self-efficacy - change (Gain in Alzheimer care INstrument (GAIN))
Time Frame: Baseline to 12-weeks
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The GAIN consists of 10-items (e.g., increased my self-awareness, increased my knowledge and skills in dementia care) using a Likert scale from 0 (disagree a lot) to 4 (agree a lot).
Scores range from 0 to 40 with higher scores indicating increased positive feelings about caregiving
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Baseline to 12-weeks
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Caregiver burden - change (Zarit Burden Interview, 6-item version)
Time Frame: Baseline to 12-weeks
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The Zarit Burden Interview is one of the most widely used assessments for caregiver burden covering areas including caregiver's health, psychological well-being, finances, social life, and the relationship between the caregiver and the person with dementia.
Scores range from 0-24 with higher scores indicating positive caregiver experience.
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Baseline to 12-weeks
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Caregiver social isolation - change (PROMIS v2.0 social isolation scale)
Time Frame: Baseline to 12-weeks
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The Patient-Reported Outcomes Measurement Information System v2.0 social isolation scale consists of 4 items (feeling left out, people barely know me, feeling isolated, people are around but not with me) that are rated as 1 (never), 2 (rarely), 3 (sometimes), 4 (usually), or 5 (always).
Scores range from 0-20 with higher scores indicating less perceived social isolation.
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Baseline to 12-weeks
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Caregiver self-regulation - change (Abbreviated Multidimensional Assessment of Interoceptive Awareness-2 (MAIA) self-regulation subscale)
Time Frame: Change from baseline to 12-weeks
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The MAIA-2 - Self-regulation subscale is designed to assess ability to regulate distress by attention to body sensations (e.g., when I feel overwhelmed, I can find a calm place inside).
Scores range from 0-20 with higher scores indicating increased self-regulation.
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Change from baseline to 12-weeks
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Caregiver positive affect (Positive States of Mind)
Time Frame: Baseline to 12-weeks
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The Positive States of Mind scale is designed to assess types of positive mood (e.g., focused attention, productivity, responsible caregiving, etc.).
This scale consists of 6-items using a 4-point Likert scale from 0 (Unable to have it) to 3 (Have it Easily).
Scores range from 0-18 with higher scores indicating positive mood.
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Baseline to 12-weeks
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Caregiver sleep - change (Symptom Checklist, 3 items)
Time Frame: Baseline to 12-weeks
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The Symptom Checklist-90-Revised is a 90-item self-report questionnaire often used to assess global psychological distress and the investigators will be using 3 items assessing: trouble falling asleep, awakening in the early morning, and sleep that is restless or disturbed.
Scores range from 0-12 with lower scores indicating less sleep difficulties.
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Baseline to 12-weeks
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People With Memory Loss (PWML) sleep - change (Symptom Checklist, 3 items)
Time Frame: Baseline to 12-weeks
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Caregivers also will be asked about sleep for the PWML using the 3 sleep items from the Symptom Checklist-90-Revised (trouble falling asleep, awakening in the early morning, and sleep that is restless or disturbed).
Scores range from 0-12 with lower scores indicating less sleep difficulties.
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Baseline to 12-weeks
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People With Memory Loss (PWML) mobility - change (Neuro-QOL Short Form V1.0 - Lower Extremity Function - Mobility)
Time Frame: Baseline to 12-weeks
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As described above, the Neuro-QOL Short Form v1.0 - Lower Extremity Function - Mobility includes 8 items for functional mobility (e.g.
getting on and off the toilet, getting in and out of a car, getting out of bed into a chair, etc.).
CGs will be asked about the mobility of the PWML.
Scores range from 0-35 with higher scores indicating less physical difficulty with daily activities.
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Baseline to 12-weeks
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People With Memory Loss (PWML) cognitive function - change (Cognitive Function Instrument - Modified)
Time Frame: Baseline to 12-weeks
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The original Cognitive Function Instrument included 14 items that asked about decline in cognitive function (e.g., memory, tendency to repeat questions, misplacing things, etc.) compared to 1 year ago with responses of yes (1), no (0) or maybe (0.5).
The investigators will be using a modified 11-item version that excludes items on driving, managing money, work; asking about change in the past 3 months (to match the duration of our study); and using a 5-point Likert scale from 1 (a lot worse) to 5 (a lot better).
Scores range from 0-55 with higher scores indicating improved cognitive function.
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Baseline to 12-weeks
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Preventing Loss of Independence through Éxercise (PLIÉ) Experience Scale
Time Frame: 12 weeks in the immediate start group. 24 weeks in the delayed start group.
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The PLIÉ Experience Scale is designed to capture feelings of stigma as well as elements of the program that participants have self-reported change.
Six items including (belonging, acceptance, problems are not unique, energy, relaxation, enjoying being with similar people are rated on a 4-point Likert scale.
Scores range from 0-24 with higher scores indicating positive feelings about the PLIÉ program.
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12 weeks in the immediate start group. 24 weeks in the delayed start group.
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Final Evaluation Survey
Time Frame: 12 weeks in the immediate start group. 24 weeks in the delayed start group.
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After completing the final class, participants will be asked to provide an overall rating of the program (poor, fair, good, or excellent), to indicate whether they would recommend it to others on a 11-point Likert scale (0, not at all likely to 10, highly likely), as well as open-ended questions that will ask about qualitative changes observed in themselves, their study partners, and others in the class; what they liked most, and suggestions for improvement.
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12 weeks in the immediate start group. 24 weeks in the delayed start group.
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Health Services Utilization
Time Frame: 24 weeks
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Emergency department/urgent care visits, hospitalizations (Number/month)
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24 weeks
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Caregiver (CG) Falls
Time Frame: 24 weeks
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Number of falls for CG
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24 weeks
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People with Memory Loss (PWML) Falls
Time Frame: 24 weeks
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Number of falls for PWML
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24 weeks
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Deborah Barnes, PhD, MPH, University of California, San Francisco
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R44AG059520 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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