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A Dyadic Approach for a Remote Physical Activity Intervention in Adults With AD and Their 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: NCT04102514
Recruitment Status : Recruiting
First Posted : September 25, 2019
Last Update Posted : November 4, 2020
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
University of Kansas

Tracking Information
First Submitted Date  ICMJE September 23, 2019
First Posted Date  ICMJE September 25, 2019
Last Update Posted Date November 4, 2020
Actual Study Start Date  ICMJE July 6, 2020
Estimated Primary Completion Date November 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 23, 2019)
Moderate Physical Activity [ Time Frame: Baseline to 18 months ]
Moderate physical activity will be assessed using an ActiGraph model wGT3x-BT triaxial at baseline, 3, 6, 12 and 18 months. accelerometer.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 23, 2020)
  • Sedentary time [ Time Frame: Baseline to 18 months ]
    Sedentary time will be assessed using an ActiGraph model wGT3x-BT triaxial at baseline, 6, 12 and 18 months.
  • Functional Fitness [ Time Frame: Baseline to 18 months ]
    Functional fitness will be measured at baseline, 6, 12 and 18 months using Functional Fitness Test (FFT) previously called the Senior Fitness Test. The individual fitness test items involve common activities such as getting up from a chair, walking, lifting, bending, and stretching.
  • Activities of Daily Living [ Time Frame: Baseline to 18 months ]
    Activities of daily living will be assessed at baseline, 6, 12 and 18 months using the Disabilities Assessment for Dementia (DAD). The DAD includes 40 items: 17 related to basic self-care and 23 to instrumental activities of daily living.
  • Change in Quality of Life [ Time Frame: Baseline to 18 months ]
    Quality of life will be assessed at baseline to 18 months using the QOL-AD, a brief, 13-item self-report and 15-item caregiver-report.
  • Residential Transitions [ Time Frame: Baseline to 18 months ]
    Residential transitions, i.e., from home to institutional care, will be tracked by health coaches. Caregiver desire to institutionalize the adult with AD will be assessed using the 6-item Morycz's Desire-to-Institutionalize Scale
  • Cognitive Function [ Time Frame: Baseline to 18 months ]
    Cognitive function will be assessed at baseline, 6, 12 and 18 months using Applied Cognition Abilities 4a instruments from the Patient-Reported Outcomes Measurement Information System (PROMIS) Cognitive Function Battery. Both test contain 4 questions that will be answered by the adult with AD.
  • Caregiver Sedentary Time [ Time Frame: Baseline to 18 months ]
    Caregiver sedentary time will be assessed using an ActiGraph model wGT3x-BT triaxial at baseline, 6, 12 and 18 months.
  • Caregiver Functional Fitness [ Time Frame: Baseline to 18 months ]
    Caregiver functional fitness will be measured at baseline, 6, 12 and 18 months using Functional Fitness Test (FFT) previously called the Senior Fitness Test. The individual fitness test items involve common activities such as getting up from a chair, walking, lifting, bending, and stretching.
  • Caregiver Quality of Life [ Time Frame: Baseline to 18 months ]
    Caregiver quality of life will be assessed at baseline, 6, 12 and 18 months using the SF-36, which involves 36 questions relating to quality of life in typically developed adults.
  • Caregiver Burden [ Time Frame: Baseline to 18 months ]
    Caregiver Burden will be assessed at baseline, 6, 12 and 18 months using the Zarit Burden Interview-short version, a 12-item self-report questionnaire in which the caregiver is asked to answer using a 5-point scale.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 23, 2019)
  • Sedentary time [ Time Frame: Baseline to 18 months ]
    Sedentary time will be assessed using an ActiGraph model wGT3x-BT triaxial at baseline, 6, 12 and 18 months.
  • Functional Fitness [ Time Frame: Baseline to 18 months ]
    Functional fitness will be measured at baseline, 6, 12 and 18 months using Functional Fitness Test (FFT) previously called the Senior Fitness Test. The individual fitness test items involve common activities such as getting up from a chair, walking, lifting, bending, and stretching.
  • Activities of Daily Living [ Time Frame: Baseline to 18 months ]
    Activities of daily living will be assessed at baseline, 6, 12 and 18 months using the Disabilities Assessment for Dementia (DAD). The DAD includes 40 items: 17 related to basic self-care and 23 to instrumental activities of daily living.
  • Change in Quality of Life [ Time Frame: Baseline to 18 months ]
    Quality of life will be assessed at baseline to 18 months using the QOL-AD, a brief, 13-item self-report and 15-item caregiver-report.
  • Residential Transitions [ Time Frame: Baseline to 18 months ]
    Residential transitions, i.e., from home to institutional care, will be tracked by health coaches. We will also assess caregiver desire to institutionalize the adult with AD using the 6-item Morycz's Desire-to-Institutionalize Scale
  • Neuropsychiatric Symptoms [ Time Frame: Baseline to 18 months ]
    Neuropsychiatric symptoms will be assessed at baseline, 6, 12 and 18 months using the Neuropsychiatric Inventory (NPI). The NPI evaluates 12 neuropsychiatric disturbances common in dementia and the amount of caregiver distress engendered by each of the neuropsychiatric disorders.
  • Cognitive Function [ Time Frame: Baseline to 18 months ]
    Cognitive function will be assessed at baseline, 6, 12 and 18 months using the Symbol Digit Modalities Test (SDMT). This test involves a simple substitution task where the taker has 90 seconds to pair specific numbers with given geometric figures.
  • Caregiver Sedentary Time [ Time Frame: Baseline to 18 months ]
    Caregiver sedentary time will be assessed using an ActiGraph model wGT3x-BT triaxial at baseline, 6, 12 and 18 months.
  • Caregiver Functional Fitness [ Time Frame: Baseline to 18 months ]
    Caregiver functional fitness will be measured at baseline, 6, 12 and 18 months using Functional Fitness Test (FFT) previously called the Senior Fitness Test. The individual fitness test items involve common activities such as getting up from a chair, walking, lifting, bending, and stretching.
  • Caregiver Quality of Life [ Time Frame: Baseline to 18 months ]
    Caregiver quality of life will be assessed at baseline, 6, 12 and 18 months using the SF-36, which involves 36 questions relating to quality of life in typically developed adults.
  • Caregiver Burden [ Time Frame: Baseline to 18 months ]
    Caregiver Burden will be assessed at baseline, 6, 12 and 18 months using the Zarit Burden Interview-short version, a 12-item self-report questionnaire in which the caregiver is asked to answer using a 5-point scale.
Current Other Pre-specified Outcome Measures
 (submitted: March 23, 2020)
  • Body Mass Index [ Time Frame: Baseline to 18 months ]
    Weight will be measured in duplicate at baseline, 6, 12 and 18 months in light clothing on a calibrated scale (Model #PS6600, Belfour, Saukville, WI) to the nearest 0.1 kg. Standing height will be measured at baseline, 6, 12 and 18 months in duplicate with a portable stadiometer (Model #IP0955, Invicta Plastics Limited, Leicester, UK). BMI will be calculated as weight (kg)/height (m2).
  • Session Attendance [ Time Frame: Baseline to 18 months ]
    Session attendance for group exercise (RGV only) and support sessions will be obtained from records maintained by the health coach, and expressed as the percent of possible sessions from 0-6 mos. and 7-12 mos. Attendance for adults with AD, enrolled caregivers, and alternative caregivers will be recorded separately.
  • Use of recorded videos [ Time Frame: Baseline to 18 months ]
    Use of recorded videos including frequency and duration of access (RGV only) will be assessed using Dropbox® analytics.
  • Self-monitoring of physical activity [ Time Frame: Baseline to 18 months ]
    Self-monitoring of physical activity will be assessed as the percentage of days with Fitbit data over a minimum of 8 hrs., between 6 am and midnight
  • Peer interactions (RGV only) [ Time Frame: Baseline to 18 months ]
    Staff will review video recordings of a random sample of 33% of group exercise sessions to identify and classify both peer to peer, and health coach to participant interactions. Interactions will be quantified and coded as verbal/non-verbal (waving, pointing, shaking head in agreement/disagreement), and as positive, neutral or negative, relative to support.
  • Caregiver support [ Time Frame: Baseline to 18 months ]
    Caregiver support will be assessed using the percentage of group exercise sessions (RGV) and/ or individual support sessions completed by both the person with AD and their caregiver.
  • Quality of the dyadic relationship [ Time Frame: Baseline to 18 months ]
    Quality of the dyadic relationship will be assessed at baseline, 6, 12, and 18 mos. using the dyadic relationship scale (DRS) which measures negative and positive dyadic interactions from the perspective of both the patient and the caregiver.
Original Other Pre-specified Outcome Measures
 (submitted: September 23, 2019)
  • Body Mass Index [ Time Frame: Baseline to 18 months ]
    Weight will be measured in duplicate at baseline, 6, 12 and 18 months in light clothing on a calibrated scale (Model #PS6600, Belfour, Saukville, WI) to the nearest 0.1 kg. Standing height will be measured at baseline, 6, 12 and 18 months in duplicate with a portable stadiometer (Model #IP0955, Invicta Plastics Limited, Leicester, UK). BMI will be calculated as weight (kg)/height (m2).
  • Session Attendance [ Time Frame: Baseline to 18 months ]
    Session attendance for group exercise (RGV only) and support sessions will be obtained from records maintained by the health coach, and expressed as the percent of possible sessions from 0-6 mos. and 7-12 mos. Attendance for adults with AD, enrolled caregivers, and alternative caregivers will be recorded separately.
  • Use of recorded videos [ Time Frame: Baseline to 18 months ]
    Use of recorded videos including frequency and duration of access (RGV only) will be assessed using Dropbox® analytics.
  • Self-monitoring of physical activity [ Time Frame: Baseline to 18 months ]
    Self-monitoring of physical activity will be assessed as the percentage of days with Fitbit data over a minimum of 8 hrs., between 6 am and midnight
  • Peer interactions (RGV only) [ Time Frame: Baseline to 18 months ]
    Staff will review video recordings of a random sample of 33% of group exercise sessions to identify and classify both peer to peer, and health coach to participant interactions. Interactions will be quantified and coded as verbal/non-verbal (waving, pointing, shaking head in agreement/disagreement), and as positive, neutral or negative, relative to support, using a modification of a checklist we previously developed for a group video exercise intervention for adolescents with IDD
  • Caregiver support [ Time Frame: Baseline to 18 months ]
    Caregiver support will be assessed using the percentage of group exercise sessions (RGV) and/ or individual support sessions completed by both the person with AD and their caregiver.
  • Quality of the dyadic relationship [ Time Frame: Baseline to 18 months ]
    Quality of the dyadic relationship will be assessed at baseline, 6, 12, and 18 mos. using the dyadic relationship scale (DRS) which measures negative and positive dyadic interactions from the perspective of both the patient and the caregiver.
  • Type of dyadic relationship [ Time Frame: Baseline to 18 months ]
    We will document the type of caregiver, e.g., spouse, adults child, paid staff, and evaluate the impact of caregiver on our primary and secondary outcomes.
  • Number of caregivers [ Time Frame: Baseline to 18 months ]
    We will document the number of different caregivers for adults with AD and evaluate the impact of change in caregivers on our primary and secondary outcomes.
  • Level of Dementia [ Time Frame: Baseline ]
    Level of dementia will be assessed at baseline using the CDR. The CDR is calculated on the basis of testing six different cognitive and behavioral domains such as memory, orientation, judgment and problem solving. The CDR is based on a scale of 0-3: no dementia (CDR = 0), questionable dementia (CDR = 0.5), MCI (CDR = 1), moderate cognitive impairment (CDR = 2), and severe cognitive impairment (CDR = 3).
 
Descriptive Information
Brief Title  ICMJE A Dyadic Approach for a Remote Physical Activity Intervention in Adults With AD and Their Caregivers
Official Title  ICMJE A Dyadic Approach for a Remote Physical Activity Intervention in Adults With AD and Their Caregivers
Brief Summary The objective of this study is to compare the effectiveness of 2 intervention delivery strategies for increasing moderate physical activity (MPA), real-time group video conferencing (RGV) vs. enhanced usual care (EUC), in community dwelling adults with Alzheimer's diseases (AD) and their caregiver (dyads) over 18 mos. (6 mos. active, 6 mos. maintenance, 6 mos. no contact). The primary outcome is to compare total MPA (min/wk.), assessed using ActiGraph, in adults with AD from baseline to 6 mos. Secondary aims for the Adults with AD are to compare MPA (min/wk), sedentary time (min/wk.), percentage meeting 150 min/wk. goal, functional fitness, activities of daily living (basic/instrumental), quality of life, residential transitions, and cognitive function across 18 months between RGV and EUC. Secondary aims for the caregivers are to compare total MPA (min/wk.), sedentary time (min/wk.), functional fitness, quality of life, caregiver burden across 18 months between RGV and EUC. Additionally, as an exploratory aim, this study will evaluate the influence of process variables/participant characteristics on MPA in adults with AD and their caregiver across 6, 12 & 18 mos.: age, sex, BMI, attendance (exercise/support sessions), use of recorded videos, PA self-monitoring, peer interactions during group sessions, caregiver support, type and quality of dyadic relationship, and number of caregivers.
Detailed Description This study will compare 2 strategies for the delivery of an intervention to increase moderate physical activity (MPA) in community dwelling adults with AD and their caregiver (dyads); real-time group video conferencing (RGV) vs. enchanced usual care (EUC). Adults (age ≥ 55 yrs.) with mild to moderate AD (n=100) and their caregiver (n=100) will be randomized (1:1) to one of the 2 intervention arms for an 18-mo. trial (6 mos. active intervention, 6 mos. maintenance, 6 mos no contact). Cohorts of ~20 dyads will be recruited and computer randomized. Dyads will be stratified by the sex of the person with AD, and sequentially randomized by the study statistician with equal allocation to the RGV or EUC arms. Participants in both arms will be provided with an iPad® for intervention delivery, Fitbit (Fitbit Inc., San Francisco, CA) for self-monitoring MPA, and will be asked to complete 150 min of MPA/wk. Dyads in the RGV arm will be asked to complete three 45 min sessions that include aerobic, resistance, and balance/coordination exercises delivered by a trained health coach via Zoom® software on an iPad during mos. 0-6, and 1 session/wk. during mos. 7-12 to groups of 5-8 dyads in their home. Dyads in the EUC arm, will be given a recommended exercise plan to follow own their own. Dyads in both arms will be provided with written materials regarding exercise and physical activity from the National Institute on Aging and will be asked to complete brief (15-20 min) FaceTime meetings (0-6 mos.= 2/mo.; 7-12 mos.= 1/mo.) with the heath coach to discuss progress, provide support and receive additional guidance on how to increase MPA. All outcomes will be collected by trained research assistants who are blinded to the study condition. The primary outcome, total MPA, will be assessed, in both individuals with AD and caregivers, by Actigraph at baseline, 3, 6, 12 & 18 mos. All secondary/exploratory outcomes will be assessed at the individual with AD or caregivers' home at baselines, 6, 12, and 18 months. Secondary outcomes for the individual with AD are sedentary time, functional fitness, activities of daily living, quality of life, residential transition, and cognitive function. Secondary outcomes for the caregiver are sedentary time, functional fitness, quality of life, and caregiver burden. The exploratory outcomes are age, sex, BMI, attendance (exercise/support sessions), use of pre-recorded videos, PA self-monitoring, peer interactions during group sessions, caregiver support, type and quality of dyadic relationship, and number of caregivers. This trial is powered to detect a between-arm difference (RGV vs. EUC) of 10 min./d. in MPA. This difference represents additional 70 mins. of MPA/wk. in the RGV arm. Power analysis shows that 84 participants (42/arm) would provide 81% power to test an overall between-arm difference across time, i.e., group effect. This sample size would also provide ≥ 80% power to detect a between-arm difference in change, i.e., group-by-time interaction, as small as f = 0.10. Thus, conservatively assuming a high attrition rate of 20%, the study team will recruit 100 dyads at baseline to assure the final sample size requirements are achieved, i.e., final N ≥ 84 (thus, power ≥ 80%) with attrition up to 20%. General mixed modeling for repeated measures will be utilized to evaluate the primary aim to compare total MPA (min/wk.) across the 6 mo. active intervention in adults with AD and their caregiver randomized to the RGV and EUC interventions. A similar mixed modeling analysis will be conducted to examine the secondary aim. General mixed models will be fitted for the two arms combined to examine the association for the process variables/participant characteristics with MPA. However, if there is a significant between-arm difference in MPA, the investigators will determine whether the process variables/participant characteristics amplify or attenuate the RGV effect, i.e., moderation, by testing a 2-way interaction with the group effect and/or a 3-way interaction with the group-by-time interaction term.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Alzheimer Disease
Intervention  ICMJE
  • Behavioral: Real-time Group Video
    Dyads in the RGV arm will be asked to complete three 45 min sessions that include aerobic, resistance, and balance/coordination exercises delivered by a trained health coach via Zoom® software on an iPad during mos. 0-6, and 1 session/wk. during mos. 7-12 to groups of 5-8 dyads in their home along with being provided written materials regarding exercise and physical activity from the National Institute on Aging and brief (15-20 min) FaceTime meetings (0-6 mos.= 2/mo.; 7-12 mos.= 1/mo.) with the heath coach to discuss progress, provide support and receive additional guidance on how to increase MPA.
  • Behavioral: Enhanced Usual Care
    Dyads in the EUC arm, will be given a recommended exercise plan to follow on their own along with being provided written materials regarding exercise and physical activity from the National Institute on Aging and brief (15-20 min) FaceTime meetings (0-6 mos.= 2/mo.; 7-12 mos.= 1/mo.) with the heath coach to discuss progress, provide support and receive additional guidance on how to increase MPA.
Study Arms  ICMJE
  • Real-time Group Video
    Intervention: Behavioral: Real-time Group Video
  • Enhanced Usual Care
    Intervention: Behavioral: Enhanced Usual Care
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 23, 2019)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2023
Estimated Primary Completion Date November 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Adults with AD -

  1. Very mild to moderate dementia
  2. Age ≥ 55 yrs
  3. Low-risk of falls
  4. Ability to participate in MPA, e.g., walk including with an assistive device, as verified PCP clearance.
  5. Ability to communicate verbally.
  6. Vision and hearing sufficient to safely comply with the intervention program as verified by PCP clearance.
  7. Reside at home and receive support from a caregiver.
  8. Internet access in the home.

Caregivers-

  1. Age ≥18 yrs.
  2. Spends at least 20 hrs./wk. with the adult with AD.

Exclusion Criteria: Adults with AD-

  1. Current exercise, i.e., > 3, 30-min bouts of planned exercise/wk.
  2. Clinically significant psychiatric disorder; systemic illness or infection likely to affect safety; clinically-evident stroke; myocardial infarction or coronary artery disease in the last 2 yrs.; cancer in the last 5 yrs.; or significant pain or musculoskeletal symptoms that would prohibit exercise.
  3. Unwilling to be randomized.

Caregivers-

  1. Unable to participate in MPA, i.e., brisk walking.
  2. Unwilling to be randomized.
  3. Serious medical risk, such as cancer within the last 5 yrs. or cardiac event, i.e., heart attack, stroke, angioplasty within the last 2 yrs.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 55 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Lauren Ptomey, PhD 9135887983 lptomey@kumc.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04102514
Other Study ID Numbers  ICMJE STUDY00144595
R01AG061187 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of Kansas
Study Sponsor  ICMJE University of Kansas
Collaborators  ICMJE National Institute on Aging (NIA)
Investigators  ICMJE Not Provided
PRS Account University of Kansas
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP