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OpenTrials
Completed

NCT Number: NCT04621448

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

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.

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Key information

Conditions

Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, San Francisco

San Francisco, California, 94143, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Moving Together

Behavioral

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.

Other names: Together Senior Health

Primary outcomes

  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 Physical Health - Change (Short Form Health Survey [SF-12] Physical Composite Score [PCS])

    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.

  3. Caregiver Mental Health - Change (Short Form - 12 [SF-12] Mental Composite Score [MCS])

    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 outcomes

  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 outcomes

  1. Caregiver (CG) Falls

    Time frame: Baseline to 12 weeks

    Total number of falls reported for CG for the entire group (not per CG)

  2. People With Memory Loss (PWML) Falls

    Time frame: Baseline to 12 weeks

    Total number of falls reported for PWML in the entire group (not per participant).

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

Extending Independence and Quality of Life for People With Alzheimer's Disease or Dementia Through Telehealth Program Delivery

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Nov 9, 2020
Registry last updated
Apr 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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