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Moving Together: An Online Group Movement Program for People Living With Memory Loss and Caregivers

Primary Purpose

Alzheimer Disease, Dementia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Moving Together
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of California, San Francisco

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Immediate Start

Delayed Start

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Quality of life - change (Quality of Life in Alzheimer's Disease Scale, QOL-AD)
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.
Caregiver Health - change (Short Form Health Survey (SF-12))
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.

Secondary Outcome Measures

Well-being - change (Neuro-QOL v1.0 Positive Affect and Well-Being Short Form)
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.
Social isolation - change (Patient-Reported Outcomes Measurement Information System v2.0 social isolation scale)
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.
Mobility - change (Neuro-QOL Short Form V1.0 - Lower Extremity Function - Mobility)
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.
Cognitive function - change (telephone Montreal Cognitive Assessment, t-MoCA)
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.
Caregiver Healthy Days - change (Healthy Days Core Module)
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.
Caregiver self-efficacy - change (Gain in Alzheimer care INstrument (GAIN))
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
Caregiver burden - change (Zarit Burden Interview, 6-item version)
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.
Caregiver social isolation - change (PROMIS v2.0 social isolation scale)
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.
Caregiver self-regulation - change (Abbreviated Multidimensional Assessment of Interoceptive Awareness-2 (MAIA) self-regulation subscale)
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.
Caregiver positive affect (Positive States of Mind)
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.
Caregiver sleep - change (Symptom Checklist, 3 items)
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.
People With Memory Loss (PWML) sleep - change (Symptom Checklist, 3 items)
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.
People With Memory Loss (PWML) mobility - change (Neuro-QOL Short Form V1.0 - Lower Extremity Function - Mobility)
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.
People With Memory Loss (PWML) cognitive function - change (Cognitive Function Instrument - Modified)
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.

Full Information

First Posted
November 3, 2020
Last Updated
June 26, 2023
Sponsor
University of California, San Francisco
Collaborators
National Institute on Aging (NIA)
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1. Study Identification

Unique Protocol Identification Number
NCT04621448
Brief Title
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

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
November 18, 2020 (Actual)
Primary Completion Date
June 3, 2023 (Actual)
Study Completion Date
June 12, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
National Institute on Aging (NIA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease, Dementia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
Delayed-start control group
Masking
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.
Allocation
Randomized
Enrollment
195 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Immediate Start
Arm Type
Experimental
Arm Description
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.
Arm Title
Delayed Start
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Moving Together
Other Intervention Name(s)
Together Senior Health
Intervention Description
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: repetition with variation (to promote procedural learning); progressive, functional movements (to improve daily function); slow pace and step-by-step instruction (to minimize cognitive demands); participant-centered goal orientation (to enhance personal meaningfulness of movements); body awareness, mindfulness and breathing (to encourage present-centeredness); social interaction (to promote meaningful connection); and positive emotions (to promote feelings of well-being.
Primary Outcome Measure Information:
Title
Quality of life - change (Quality of Life in Alzheimer's Disease Scale, QOL-AD)
Description
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.
Time Frame
Baseline to 12-weeks
Title
Caregiver Health - change (Short Form Health Survey (SF-12))
Description
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.
Time Frame
Baseline to 12-weeks
Secondary Outcome Measure Information:
Title
Well-being - change (Neuro-QOL v1.0 Positive Affect and Well-Being Short Form)
Description
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.
Time Frame
Baseline to 12-weeks
Title
Social isolation - change (Patient-Reported Outcomes Measurement Information System v2.0 social isolation scale)
Description
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.
Time Frame
Baseline to 12-weeks
Title
Mobility - change (Neuro-QOL Short Form V1.0 - Lower Extremity Function - Mobility)
Description
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.
Time Frame
Baseline to 12-weeks
Title
Cognitive function - change (telephone Montreal Cognitive Assessment, t-MoCA)
Description
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.
Time Frame
Baseline to 12-weeks
Title
Caregiver Healthy Days - change (Healthy Days Core Module)
Description
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.
Time Frame
Baseline to 12-weeks
Title
Caregiver self-efficacy - change (Gain in Alzheimer care INstrument (GAIN))
Description
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
Time Frame
Baseline to 12-weeks
Title
Caregiver burden - change (Zarit Burden Interview, 6-item version)
Description
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.
Time Frame
Baseline to 12-weeks
Title
Caregiver social isolation - change (PROMIS v2.0 social isolation scale)
Description
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.
Time Frame
Baseline to 12-weeks
Title
Caregiver self-regulation - change (Abbreviated Multidimensional Assessment of Interoceptive Awareness-2 (MAIA) self-regulation subscale)
Description
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.
Time Frame
Change from baseline to 12-weeks
Title
Caregiver positive affect (Positive States of Mind)
Description
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.
Time Frame
Baseline to 12-weeks
Title
Caregiver sleep - change (Symptom Checklist, 3 items)
Description
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.
Time Frame
Baseline to 12-weeks
Title
People With Memory Loss (PWML) sleep - change (Symptom Checklist, 3 items)
Description
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.
Time Frame
Baseline to 12-weeks
Title
People With Memory Loss (PWML) mobility - change (Neuro-QOL Short Form V1.0 - Lower Extremity Function - Mobility)
Description
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.
Time Frame
Baseline to 12-weeks
Title
People With Memory Loss (PWML) cognitive function - change (Cognitive Function Instrument - Modified)
Description
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.
Time Frame
Baseline to 12-weeks
Other Pre-specified Outcome Measures:
Title
Preventing Loss of Independence through Éxercise (PLIÉ) Experience Scale
Description
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.
Time Frame
12 weeks in the immediate start group. 24 weeks in the delayed start group.
Title
Final Evaluation Survey
Description
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.
Time Frame
12 weeks in the immediate start group. 24 weeks in the delayed start group.
Title
Health Services Utilization
Description
Emergency department/urgent care visits, hospitalizations (Number/month)
Time Frame
24 weeks
Title
Caregiver (CG) Falls
Description
Number of falls for CG
Time Frame
24 weeks
Title
People with Memory Loss (PWML) Falls
Description
Number of falls for PWML
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deborah Barnes, PhD, MPH
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Sharing permissions will be configured to ensure files containing PHI can only be accessed by authorized individuals. Two-step verification will be used as an additional safeguard against unauthorized access. Permissions will be updated when personnel roles change and they no longer need access to PHI or when they leave the research team.
Citations:
PubMed Identifier
25671576
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.
Results Reference
background
PubMed Identifier
30744387
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.
Results Reference
background
PubMed Identifier
25022459
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.
Results Reference
background

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Moving Together: An Online Group Movement Program for People Living With Memory Loss and Caregivers

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