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

Alzheimer Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04621448
• Other study ID #: R44AG059520
• Secondary ID: R44AG059520
• Status: Completed
• Phase: N/A
• Start date: November 18, 2020
• Est. completion date: May 12, 2023

Study information

• Verified date: November 2023
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 197
• Est. completion date: May 12, 2023
• Est. primary completion date: May 3, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Alzheimer Disease
• Dementia

Intervention

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: 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.

Locations

Country	Name	City	State
United States	University of California, San Francisco	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Preventing Loss of Independence through Éxercise (PLIÉ) Experience Scale	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.	12 weeks in the immediate start group. 24 weeks in the delayed start group.
Other	Final Evaluation Survey	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.	12 weeks in the immediate start group. 24 weeks in the delayed start group.
Other	Health Services Utilization	Emergency department/urgent care visits, hospitalizations (Number/month)	24 weeks
Other	Caregiver (CG) Falls	Number of falls for CG	24 weeks
Other	People with Memory Loss (PWML) Falls	Number of falls for PWML	24 weeks
Primary	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.	Baseline to 12-weeks
Primary	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.	Baseline to 12-weeks
Secondary	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.	Baseline to 12-weeks
Secondary	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.	Baseline to 12-weeks
Secondary	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.	Baseline to 12-weeks
Secondary	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.	Baseline to 12-weeks
Secondary	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.	Baseline to 12-weeks
Secondary	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	Baseline to 12-weeks
Secondary	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.	Baseline to 12-weeks
Secondary	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.	Baseline to 12-weeks
Secondary	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.	Change from baseline to 12-weeks
Secondary	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.	Baseline to 12-weeks
Secondary	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.	Baseline to 12-weeks
Secondary	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.	Baseline to 12-weeks
Secondary	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.	Baseline to 12-weeks
Secondary	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.	Baseline to 12-weeks