Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04621448
Recruitment Status : Recruiting
First Posted : November 9, 2020
Last Update Posted : May 25, 2021
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
University of California, San Francisco

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.

Condition or disease Intervention/treatment Phase
Alzheimer Disease Dementia Behavioral: Moving Together Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 224 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Delayed-start control group
Masking: Single (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.
Primary Purpose: Treatment
Official Title: Extending Independence and Quality of Life for People With Alzheimer's Disease or Dementia Through Telehealth Program Delivery
Actual Study Start Date : November 18, 2020
Estimated Primary Completion Date : September 30, 2022
Estimated Study Completion Date : September 30, 2022


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.
Behavioral: Moving Together

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:

  1. repetition with variation (to promote procedural learning);
  2. progressive, functional movements (to improve daily function);
  3. slow pace and step-by-step instruction (to minimize cognitive demands);
  4. participant-centered goal orientation (to enhance personal meaningfulness of movements);
  5. body awareness, mindfulness and breathing (to encourage present-centeredness);
  6. social interaction (to promote meaningful connection); and
  7. positive emotions (to promote feelings of well-being.
Other Name: Together Senior Health

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.
Behavioral: Moving Together

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:

  1. repetition with variation (to promote procedural learning);
  2. progressive, functional movements (to improve daily function);
  3. slow pace and step-by-step instruction (to minimize cognitive demands);
  4. participant-centered goal orientation (to enhance personal meaningfulness of movements);
  5. body awareness, mindfulness and breathing (to encourage present-centeredness);
  6. social interaction (to promote meaningful connection); and
  7. positive emotions (to promote feelings of well-being.
Other Name: Together Senior Health




Primary Outcome Measures :
  1. Quality of life - change (Quality of Life in Alzheimer's Disease Scale, QOL-AD) [ Time Frame: Baseline to 12-weeks ]
    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.

  2. Caregiver Health - change (Short Form Health Survey (SF-12)) [ Time Frame: Baseline to 12-weeks ]
    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 :
  1. Well-being - change (Neuro-QOL v1.0 Positive Affect and Well-Being Short Form) [ Time Frame: Baseline to 12-weeks ]
    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.

  2. Social isolation - change (Patient-Reported Outcomes Measurement Information System v2.0 social isolation scale) [ Time Frame: Baseline to 12-weeks ]
    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.

  3. Mobility - change (Neuro-QOL Short Form V1.0 - Lower Extremity Function - Mobility) [ Time Frame: Baseline to 12-weeks ]
    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.

  4. Cognitive function - change (telephone Montreal Cognitive Assessment, t-MoCA) [ Time Frame: Baseline to 12-weeks ]
    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.

  5. Caregiver Healthy Days - change (Healthy Days Core Module) [ Time Frame: Baseline to 12-weeks ]
    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.

  6. Caregiver self-efficacy - change (Gain in Alzheimer care INstrument (GAIN)) [ Time Frame: Baseline to 12-weeks ]
    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

  7. Caregiver burden - change (Zarit Burden Interview, 6-item version) [ Time Frame: Baseline to 12-weeks ]
    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.

  8. Caregiver social isolation - change (PROMIS v2.0 social isolation scale) [ Time Frame: Baseline to 12-weeks ]
    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.

  9. Caregiver self-regulation - change (Abbreviated Multidimensional Assessment of Interoceptive Awareness-2 (MAIA) self-regulation subscale) [ Time Frame: Change from baseline to 12-weeks ]
    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.

  10. Caregiver positive affect (Positive States of Mind) [ Time Frame: Baseline to 12-weeks ]
    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.

  11. Caregiver sleep - change (Symptom Checklist, 3 items) [ Time Frame: Baseline to 12-weeks ]
    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.

  12. People With Memory Loss (PWML) sleep - change (Symptom Checklist, 3 items) [ Time Frame: Baseline to 12-weeks ]
    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.

  13. People With Memory Loss (PWML) mobility - change (Neuro-QOL Short Form V1.0 - Lower Extremity Function - Mobility) [ Time Frame: Baseline to 12-weeks ]
    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.

  14. People With Memory Loss (PWML) cognitive function - change (Cognitive Function Instrument - Modified) [ Time Frame: Baseline to 12-weeks ]
    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.


Other Outcome Measures:
  1. 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. ]
    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.

  2. Final Evaluation Survey [ Time Frame: 12 weeks in the immediate start group. 24 weeks in the delayed start group. ]
    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.

  3. Health Services Utilization [ Time Frame: 24 weeks ]
    Emergency department/urgent care visits, hospitalizations (Number/month)

  4. Caregiver (CG) Falls [ Time Frame: 24 weeks ]
    Number of falls for CG

  5. People with Memory Loss (PWML) Falls [ Time Frame: 24 weeks ]
    Number of falls for PWML



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04621448


Contacts
Layout table for location contacts
Contact: Deborah E Barnes, PhD, MPH 415-298-5498 deborah.barnes@ucsf.edu
Contact: Cynthia Benjamin 650-906-6032 cbenjamin@togetherseniorhealth.com

Locations
Layout table for location information
United States, California
University of California, San Francisco Recruiting
San Francisco, California, United States, 94143
Principal Investigator: Deborah E Barnes, PhD, MPH         
Sponsors and Collaborators
University of California, San Francisco
National Institute on Aging (NIA)
Investigators
Layout table for investigator information
Principal Investigator: Deborah Barnes, PhD, MPH University of California, San Francisco
Publications:
Layout table for additonal information
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT04621448    
Other Study ID Numbers: R44AG059520 ( U.S. NIH Grant/Contract )
R44AG059520 ( U.S. NIH Grant/Contract )
First Posted: November 9, 2020    Key Record Dates
Last Update Posted: May 25, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders