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| ID | Type | Description | Link |
|---|---|---|---|
| R44AG059520 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immediate Start | Experimental | 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. |
|
| Delayed Start | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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:
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Caregiver Physical Health - Change (Short Form Health Survey [SF-12] Physical Composite Score [PCS]) | 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 |
| Caregiver Mental Health - Change (Short Form - 12 [SF-12] Mental Composite Score [MCS]) | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Caregiver (CG) Falls | Total number of falls reported for CG for the entire group (not per CG) | Baseline to 12 weeks |
| People With Memory Loss (PWML) Falls | Total number of falls reported for PWML in the entire group (not per participant). |
Inclusion Criteria:
People with memory loss (PWML):
Caregivers (CG):
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Deborah Barnes, PhD, MPH | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Francisco | San Francisco | California | 94143 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25671576 | Background | 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. | |
| 30744387 | Background | 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. |
| Label | URL |
|---|---|
| Published results | View source |
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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.
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Study participants are enrolled as dyads of persons living with dementia (PLWD) and care partners (CPs).
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| ID | Title | Description |
|---|---|---|
| FG000 | Waitlist Control - PLWD | Usual activities for 12 weeks followed by Moving Together classes (1 hour, 2 days/week) for 12 weeks for PLWD. |
| FG001 | Moving Together - PLWD | Synchronous, online, mind-body group movement classes (1 hour, 2 days/week) for 12 weeks followed by optional continuation of classes for 12 weeks for PLWD. |
| FG002 | Waitlist Control - CP | Usual activities for 12 weeks followed by Moving Together classes for 12 weeks (1 hour, 2 days/week) for CPs. |
| FG003 | Moving Together - CP | Synchronous, online, mind-body group movement classes (1 hour, 2 days/week) for 12 weeks followed by optional continuation of classes for 12 weeks for CPs. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline to 12 Weeks |
|
| ||||||||||||||||||
| 12 to 24 Weeks |
|
Participants enrolled as dyads of persons living with dementia (PLWD) and care partners (CPs).
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| ID | Title | Description |
|---|---|---|
| BG000 | Waitlist Control | Usual activities for 12 weeks followed by Moving Together classes (1 hour, 2 days/week) for 12 weeks. |
| BG001 | Moving Together | Synchronous, online, mind-body group movement classes (1 hour, 2 days/week) for 12 weeks followed by return to usual activities for 12 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | There are separate rows for PLWD and CPs. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Only measured in PLWD. Baseline data missing for 1 participant in the Moving Together group. | Posted | Mean | Standard Deviation | score on a scale | Baseline to 12-weeks |
|
24 weeks
Care partners are sent a month survey that asks about hospitalizations, emergency department visits, falls, and other unexpected major medical events or changes to health in the past month for themselves and PLWD. We did not group events by organ system; therefore, they are reported as general events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Immediate Start - Care Partners (CPs) | The Immediate Start group will participate in Moving Together classes (1 hour, 2 days/week) for 12 weeks and will then return to usual activities for 12 weeks. Adverse events are reported separately for care partners (CPs) and participants living with dementia (PLWD). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Other | General disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Any Adverse Event | General disorders | Systematic Assessment |
Dyads were enrolled in cohorts with a goal of 16 dyads per cohort. Our original target sample size of 224 dyads (112/group) was reduced to 112 dyads (56/group) following a futility analysis requested by our Safety Officer (SO). We did not penalize the alpha for this unplanned interim analysis. Due to time and funding constraints, the 7th (final) cohort only included 10 dyads, all of whom were assigned to the Immediate Start (Moving Together) group.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Deborah Barnes | University of California, San Francisco | 415-502-2943 | deborah.barnes@ucsf.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 7, 2022 | Dec 19, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D003704 | Dementia |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
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Delayed-start control group
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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.
|
|
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Baseline to 12 weeks |
| 25022459 | Background | 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. |
| 37745819 | Background | 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. |
| 38698931 | Result | Barnes DE, Jiang F, Benjamin C, Lee JA, Sudore RL, Mehling WE, Chesney MA, Chao LL, Nicosia FM. Livestream, group movement program for people living with cognitive impairment and care partners: A randomized clinical trial. Alzheimers Dement (N Y). 2024 May 2;10(2):e12467. doi: 10.1002/trc2.12467. eCollection 2024 Apr-Jun. |
| Lost to Follow-up |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | There are separate rows for PLWD and CPs. | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | There are separate rows for PLWD and CPs. | Count of Participants | Participants |
|
| Education | Separate rows are provided for PLWD and CPs | Mean | Standard Deviation | years |
|
| Dementia Diagnosis | Measure only collected for PLWD | Count of Participants | Participants |
|
| Quick Dementia Rating System (QDRS) | 10-item validated questionnaire. Scores range from 0 to 30 with higher scores indicating greater cognitive impairment. Enrollment restricted to participants with scores of 2.5 to 12.5 (mild severity). | Measure only relevant for PLWD. | Mean | Standard Deviation | points on a scale |
|
| Relationship to PLWD | Only relevant for CPs | Count of Participants | Participants |
|
|
|
|
| Primary | Caregiver Physical Health - Change (Short Form Health Survey [SF-12] Physical Composite Score [PCS]) | 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. | Measured only in CPs. | Posted | Mean | Standard Deviation | score on a scale | Baseline to 12-weeks |
|
|
|
|
| Primary | Caregiver Mental Health - Change (Short Form - 12 [SF-12] Mental Composite Score [MCS]) | 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. | Only measured in CPs. | Posted | Mean | Standard Deviation | score on a scale | 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. | Only measured in PLWD. Data missing for 1 participant. | Posted | Mean | Standard Deviation | score on a scale | 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. | Measured in PLWD. Data missing for 1 participant. | Posted | Mean | Standard Deviation | score on a scale | 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. | Measure applies to PLWD. Data missing for 1 Moving Together participant. | Posted | Mean | Standard Deviation | score on a scale | 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. | Measured only in PLWD. Data missing for 1 Moving Together participant. | Posted | Mean | Standard Deviation | score on a scale | 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. | Measure applies to CPs only. | Posted | Mean | Standard Deviation | score on a scale | 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 | Measure applies to CPs only. | Posted | Mean | Standard Deviation | score on a scale | 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. | Measure applies to CPs only. | Posted | Mean | Standard Deviation | score on a scale | 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. | Measure applies to CPs only. | Posted | Mean | Standard Deviation | score on a scale | 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. | Measure applies to CPs only. | Posted | Mean | Standard Deviation | score on a scale | 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. | Measure applies to CPs only. | Posted | Mean | Standard Deviation | score on a scale | 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. | Measure only applies to CPs. | Posted | Mean | Standard Deviation | score on a scale | 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. | Measure only asked of CPs regarding PLWD. | Posted | Mean | Standard Deviation | score on a scale | 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. | Measure asked of CPs regarding PLWD. | Posted | Mean | Standard Deviation | score on a scale | 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. | Measure asked CPs about PLWD. | Posted | Mean | Standard Deviation | score on a scale | Baseline to 12-weeks |
|
|
|
|
| Other Pre-specified | Caregiver (CG) Falls | Total number of falls reported for CG for the entire group (not per CG) | Applies to CPs only. Data missing for 2 Waitlist and 6 Moving Together CPs. | Posted | Number | falls | Baseline to 12 weeks |
|
|
|
|
| Other Pre-specified | People With Memory Loss (PWML) Falls | Total number of falls reported for PWML in the entire group (not per participant). | Applies only to PLWD. Data missing for 2 Waitlist and 6 Moving Together participants. | Posted | Number | falls | Baseline to 12 weeks |
|
|
|
|
| 0 |
| 54 |
| 1 |
| 54 |
| 3 |
| 54 |
| EG001 | Immediate Start - Participants Living With Dementia (PLWD) | The Immediate Start group will participate in Moving Together classes (1 hour, 2 days/week) for 12 weeks and will then return to usual activities for 12 weeks. Adverse events are reported separately for care partners (CPs) and participants living with dementia (PLWD). | 0 | 54 | 7 | 54 | 17 | 54 |
| EG002 | Delayed Start - Care Partners (CPs) | The Delayed Start group will engage in usual activities for 12 weeks and will then participate in Moving Together classes (1 hour, 2 days/week) for 12 weeks. Adverse events are reported separately for care partners (CPs) and participants living with dementia (PLWD). | 0 | 43 | 1 | 43 | 8 | 43 |
| EG003 | Delayed Start - Participants Living With Dementia (PLWD) | The Delayed Start group will engage in usual activities for 12 weeks and will then participate in Moving Together classes (1 hour, 2 days/week) for 12 weeks. Adverse events are reported separately for care partners (CPs) and participants living with dementia (PLWD). | 0 | 43 | 3 | 43 | 15 | 43 |
Not provided
Not provided
| D019636 |
| Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| Male |
|
| Hispanic/Latino/a/x (any race) |
|
| Non-Hispanic White |
|
| Other/unknown race/ethnicity |
|
| Black or African American |
|
| Hispanic/Latino/a/x (any race) |
|
| Non-Hispanic White |
|
| Other/unknown race/ethnicity |
|
| Mild cognitive impairment |
|
| Mixed dementia |
|
| Vascular dementia |
|
| Other/unknown type of dementia |
|
| Paid |
|
| Other relationship |
|