Technology and Family Thriving Study (Thrive)

Using Rendever to Improve the Quality of Life of Older Adults With Cognitive Impairments in Senior Living Communities and Their Family Members Who Live at a Distance

The purpose of this project is to test the impact of different forms of technology (virtual reality vs. video chat) on quality of life and family relationships in older adults who reside in senior living communities and an adult child who lives at a distance. The study will also investigate whether responses to the technology and quality of life outcomes depend on older adults' level of cognitive impairment.

Study Overview

• Status: Completed
• Conditions: Quality of Life; Dementia; Alzheimer Disease; Mental Health Wellness 1; Loneliness; Caregiver Burnout; Family Relationship
• Intervention / Treatment: Behavioral: Virtual Reality; Behavioral: Video Chat

Detailed Description

Purpose of the clinical trial: The virtual reality (VR) program, Rendever, enables older adults in senior living communities to maintain important family relationships, engage fully with life, and reconnect with their past, regardless of physical location, through its advanced networking and live-streaming capabilities. This project will test the immediate and longer-term impact of the Rendever virtual reality platform (vs. video chat) on the quality of life of residents and their adult children in an experimental design. The study will also investigate whether responses to the technology and quality of life outcomes depend on older adults' level of cognitive impairment.

Participants: Participants will be older adults (age 50+) with mild cognitive impairments (MCI) or mild to moderate Alzheimer's Disease or related dementias (ADRD) who reside in senior living communities and an adult child who lives at a distance. The resident-adult child dyads (target N=192 dyads) will be recruited from 12 senior living communities in the greater Boston area and central California. Residents will participate from their senior living community and adult children will participate from their own home, at least 45 minutes driving distance away.

Study Design and Method: The design is a 2 (Intervention Group: Virtual Reality vs. Active Control) x 2 (Level of Cognitive Impairment: MCI vs. ADRD) x Time (7 time points) design. Dyads will be randomly assigned to an intervention group (Virtual Reality vs. Video Chat Control). Dependent variables will include quality of life, psychological and social well-being (loneliness, mental health, thriving, and relationship quality), caregiver guilt (guilt, stress, and burden), and positive engagement while using the technology. Outcomes will be assessed through surveys, interviews, and observational methods.

The experimental intervention will be implemented in a between-group design. Dyads will be randomly assigned to either the Virtual Reality Condition or the active Control Condition (video chat). Participants will complete a baseline survey (T1), followed by four activity sessions once a week for 4 consecutive weeks (T2-T5). Follow-up surveys will be conducted at 1-month (T6) and 3-months (T7) post-intervention for exploratory purposes (to determine if any effects of the technology are sustained over time). Residents and adult children will also be interviewed briefly after the intervention and at each follow-up. All sessions will be video and audiotaped. Computerized and human coding will examine positive engagement and interpersonal dynamics while using the technology.

Dyads assigned to the virtual reality (VR) condition will engage in 4 weekly VR sessions that include immersive virtual adventures (e.g., bucket list travel) and reminiscence activities (e.g., virtual life story). Dyads assigned to the control condition will engage in 4 weekly video chat sessions. During these sessions, dyads will engage in conversations that are typical in their daily lives. All other procedures will be identical in the two conditions.

Sample size, recruitment, and statistical power: A power analysis using simulation methods (for multi-level regression models and structural equation models) was used to determine the sample size. A sample size of 192 dyads (96 in each intervention condition) evenly split between cognitive impairment groups (MCI vs. dementia) will achieve a high level of power for detecting the minimal expected effect size (accounting for expected attrition).

Statistical analysis: Because data from parent-adult child dyads will be dependent, and because the dyad is the unit of analysis for assignment to experimental conditions, the analysis of quantitative data will utilize linear models designed for nested (clustered) data. Hypothesis testing will be conducted with multi-level, random-effects regression and multi-level structural equation modeling.

Study Aims:

AIM 1: Determine whether virtual reality (vs. control) improves quality of life for residents and their adult children who live at a distance.

AIM 2: Determine whether the positive effects of virtual reality (vs. control) on quality of life depend upon residents' level of cognitive impairment (MCI vs. mild to moderate AD/ADRD).

AIM 3: Determine whether virtual reality (vs. control) reduces caregiver guilt for adult children and whether these effects depend on the adult child's own responses to the technology and their parent's responses to the technology.

• Study Type: Interventional
• Enrollment (Actual): 186
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Calabasas, California, United States, 91302
      • Belmont Calabasas
    • Camarillo, California, United States, 93012
      • Oakmont of Camarillo
    • Goleta, California, United States, 93117
      • Friendship Manor
    • Montecito, California, United States, 93108
      • Casa Dorinda
    • Ojai, California, United States, 93023
      • Ojai Gables
    • Santa Barbara, California, United States, 93101
      • Garden Court on De La Vina
    • Santa Barbara, California, United States, 93105
      • Covenant Living at the Samarkand
    • Santa Barbara, California, United States, 93105
      • Gardens on Hope
    • Santa Barbara, California, United States, 93105
      • Grace Village Apartments
    • Santa Barbara, California, United States, 93105
      • Valle Verde
    • Santa Barbara, California, United States, 93105
      • Vista Del Monte
    • Santa Barbara, California, United States, 93111
      • Heritage House
    • Santa Barbara, California, United States, 93111
      • Maravilla
    • Solvang, California, United States, 93463
      • Atterdag Village of Solvang
  • Massachusetts
    • Andover, Massachusetts, United States, 01810
      • Stone Hill at Andover
    • Burlington, Massachusetts, United States, 01803
      • Stonebridge at Burlington
    • Cambridge, Massachusetts, United States, 02138
      • Youville House Assisted Living
    • Cambridge, Massachusetts, United States, 02140
      • Cadbury Commons
    • Canton, Massachusetts, United States, 02021
      • Brightview Canton
    • Danvers, Massachusetts, United States, 01923
      • The Linden at Danvers
    • North Andover, Massachusetts, United States, 01845
      • Brightview North Andover
    • Norwood, Massachusetts, United States, 02062
      • Benchmark of Norwood (Clapboardtree)
    • Plymouth, Massachusetts, United States, 02630
      • Laurelwood at The Pinehills
    • South Dartmouth, Massachusetts, United States, 02747
      • Autumn Glen at Dartmouth
    • Tewksbury, Massachusetts, United States, 01876
      • Bayberry at Emerald Court
    • Wayland, Massachusetts, United States, 01778
      • Carriage House at Lee's Farm
  • New Hampshire
    • Milford, New Hampshire, United States, 03055
      • Ledgewood Bay Assisted Living

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria for older adults:

• Must reside in one of the senior living communities participating in the study
• at least 50 years old
• Fluent in English or Spanish
• Have MCI or mild to moderate AD/ADRD
• Mini-mental state examination (MMSE-2) score between 13 and 27
• Have an adult child who lives at least 45 minutes driving distance from the community and is willing to participate with them
• Do not have an overly negative, aggressive, or abusive relationship with this adult child

Inclusion Criteria for adult children:

• At least 18 years old
• Fluent in English or Spanish,
• Live at least 45 minutes driving distance from the residential community
• Do not have an overly negative, aggressive, or abusive relationship with their parent

Exclusion Criteria:

• Severe AD/ADRD (MMSE-2 score < 13)
• History of seizure, severe vertigo, hallucinations, or aggression
• Severe visual impairment (screening will be conducted to determine if vision is sufficient to participate)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Virtual Reality; Weekly activities using virtual reality (Rendever)	Behavioral: Virtual Reality; Older adults (residents of senior living communities) engage in four 20-minute virtual reality activities (via the Rendever platform) with their adult child each week for 4 consecutive weeks. The 4 sessions include immersive virtual adventures (e.g., bucket list travel) and reminiscence activities (e.g., virtual life story). Adult children participate remotely from their own homes.
Active Comparator: Video Chat; Weekly activities using video conference (Zoom)	Behavioral: Video Chat; Older adults (residents of senior living communities) engage in four 20-minute video chat sessions (via the Zoom platform) with their adult child each week for 4 consecutive weeks. Adult children participate remotely from their own homes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Life in Alzheimer's Disease (QOL-AD) - Changes From Baseline (Older Adult)	QOL-AD (R.G. Logsdon, 1996) is a 13-item self-report measure of quality of life (completed by older adult participants). (As a secondary outcome, adult children also reported on their parents' quality of life). Items are rated on a 4-point scale: 1 = Poor, 2 = Fair, 3 = Good, 4 = Excellent. The total score is the mean of all items (range: 1 to 4). Higher scores indicate greater quality of life.	T1 (baseline, 1-week pre-intervention), T2 (1-week post-intervention), T3 (1-month post-intervention), T4 (3-months post-intervention)
Brief Inventory of Thriving (BIT) - Changes From Baseline (Older Adult)	An 11-item measure of thriving adapted from the Brief Inventory of Thriving (BIT) and the Comprehensive Inventory of Thriving (CIT; Su, R., Tay, L., & Diener, E., 2014). This measure provides a holistic view of positive functioning (completed by older adults and adult children). Items are rated on a 5-point scale: 1 = Strongly Disagree, 2 = Disagree, 3 = Neither Agree nor Disagree, 4 = Agree, 5 = Strongly Agree. The total score is the average of the 11 items (range: 1 to 5). Higher scores indicate a greater sense of thriving.	T1 (baseline, 1-week pre-intervention), T2 (1-week post-intervention), T3 (1-month post-intervention), T4 (3-months post-intervention)
Positive and Negative Affect Schedule (PANAS) - Changes From Baseline (Older Adult)	This scale includes 12 items from the longer PANAS (Watson, Clark, & Tellegen, 1988), which measures two primary dimensions of mood. (Completed by older adults and adult children.) Participants rate the extent to which they experienced positive and negative emotions over the past week. Each item is rated on a 5-point scale: 1 = Not at all, 2 = A little, 3 = Moderately, 4 = Quite a lot, 5 = Extremely. Separate subscale scores are calculated for positive emotion (6 items) and negative emotion (6 items) by averaging responses within each set (range: 1 to 5). Higher scores on the positive emotion subscale reflect greater positive mood during the past week, indicating better well-being. Higher scores on the negative emotion subscale reflect greater negative mood, indicating poorer well-being.	T1 (baseline, 1-week pre-intervention), T2 (1-week post-intervention), T3 (1-month post-intervention), T4 (3-months post-intervention)
Geriatric Depression Scale (GDS) - Changes From Baseline (Older Adult)	GDS (Sheikh, J.I., & Yesavage, J.A., 1986) is a 15-item self-report measure of depression (completed by older adult participants). Items are rated "Yes" or "No" and are scored "1" if the response reflects depressive symptoms. Total score is the sum of all items (range: 0 to 15). Higher scores indicate greater depression.	T1 (baseline, 1-week pre-intervention), T2 (1-week post-intervention), T3 (1-month post-intervention), T4 (3-months post-intervention)
Mental Health Inventory (MHI) - Changes From Baseline (Older Adult)	The MHI includes 5 items from the longer MHI (McHorney, Ware, & Raczek, 1993) to assess depression, anxiety, and vitality during the past week (completed by older adults and adult children). Items are rated on a 6-point scale: 1= None of the time, 2= A little of the time, 3 = Some of the time, 4 = A good bit of the time, 5 = Most of the time, 6 = All of the time. The total score is the average of all 8 items, some reverse-scored (range: 1 to 6). Higher scores indicate better mental health.	T1 (baseline, 1-week pre-intervention), T2 (1-week post-intervention), T3 (1-month post-intervention), T4 (3-months post-intervention)
Revised UCLA Loneliness Scale (Short Form) - Changes From Baseline (Older Adult)	The short form of the Revised UCLA Loneliness Scale (Hughes, Waite, Hawkley, & Cacioppo, 2008) is a 4-item scale widely used in field research with older adults, and adapted from the original scale (Russell D, Peplau LA, Cutrona CE, 1980). Items are rated on a 4-point scale: 1 = Never, 2 = Rarely, 3 = Sometimes, 4 = Often. The total score is the mean of the 4 items (range: 1 to 4). Higher scores indicate greater loneliness.	T1 (baseline, 1-week pre-intervention), T2 (1-week post-intervention), T3 (1-month post-intervention), T4 (3-months post-intervention)
Unidimensional Relationship Closeness Scale - Changes From Baseline (Older Adult)	Relationship closeness is assessed with 4 items from the Unidimensional Relationship Closeness Scale (Dibble, Levine, & Park, 2011). (Completed by older adults and adult children). Items are rated on a 7-point scale: 1 = Strongly disagree, 2 = Disagree, 3 = Somewhat disagree, 4 = Neutral, 5 = Somewhat agree, 6 = Agree, 7 = Strong Agree. The total score is the average of the 4 items (range: 1 to 7). Higher scores indicate greater relationship closeness.	T1 (baseline, 1-week pre-intervention), T2 (1-week post-intervention), T3 (1-month post-intervention), T4 (3-months post-intervention)
Relationship Satisfaction - Changes From Baseline (Older Adult)	Global relationship satisfaction is assessed with 3 items adapted from Huston et al.'s (1986) relationship satisfaction scale (completed by older adults and adult children). Items are rated on a 6-point scale: 1 = Not at all, 2 = A little, 3 = Somewhat, 4 = Very, 5 = Almost completely, 6 = Completely. Total scores are the average of the 3 items (range: 1 to 6). Higher scores indicate greater relationship satisfaction.	T1 (baseline, 1-week pre-intervention), T2 (1-week post-intervention), T3 (1-month post-intervention), T4 (3-months post-intervention)
Communal Coping - Changes From Baseline (Older Adult)	Communal coping is assessed with 3 items reflecting feelings of unity when combatting stress (Afifi et al., 2019). (Completed by older adults and adult children.) Items are rated on a 5-point scale: 1 = Strongly disagree, 2 = Disagree, 3 = Neutral, 4 = Agree, 5 = Strongly agree. The total score is the average of the 3 items (range: 1 to 5). Higher scores indicate a greater sense of communal coping.	T1 (baseline, 1-week pre-intervention), T2 (1-week post-intervention), T3 (1-month post-intervention), T4 (3-months post-intervention)
Brief Inventory of Thriving (BIT) - Changes From Baseline (Adult Child)	An 11-item measure of thriving adapted from the Brief Inventory of Thriving (BIT) and the Comprehensive Inventory of Thriving (CIT; Su, R., Tay, L., & Diener, E., 2014). This measure provides a holistic view of positive functioning (completed by older adults and adult children). Items are rated on a 5-point scale: 1 = Strongly Disagree, 2 = Disagree, 3 = Neither Agree nor Disagree, 4 = Agree, 5 = Strongly Agree. The total score is the average of the 11 items (range: 1 to 5). Higher scores indicate a greater sense of thriving.	T1 (baseline, 1-week pre-intervention), T2 (1-week post-intervention), T3 (1-month post-intervention), T4 (3-months post-intervention)
Center for Epidemiological Studies Depression Scale Revised Short Form (CESD-R-10) - Changes From Baseline (Adult Child)	The CESD-R-10 (Björgvinsson, Kertz, Bigda-Peyton, McCoy, Aderka,2013) is a 10-item measure of depressive symptoms adapted from the longer CESD (completed by adult children). Participants are asked to report how they felt during the past week. Items are rated on a 4-point scale: 0 = Rarely or none of the time, 1 = Some or a little of the time, 2 = Occasionally or a moderate amount of the time, 3 = Most or all of the time. The total score is the mean of the 10 items, some reverse-scored (range: 0 to 3). Higher scores reflect more depressive symptoms, worse mental health.	T1 (baseline, 1-week pre-intervention), T2 (1-week post-intervention), T3 (1-month post-intervention), T4 (3-months post-intervention)
Positive and Negative Affect Schedule (PANAS) - Changes From Baseline (Adult Child)	This scale includes 12 items from the longer PANAS (Watson, Clark, & Tellegen, 1988), which measures two primary dimensions of mood. (Completed by older adults and adult children.) Participants rate the extent to which they experienced positive and negative emotions over the past week. Each item is rated on a 5-point scale: 1 = Not at all, 2 = A little, 3 = Moderately, 4 = Quite a lot, 5 = Extremely. Separate subscale scores are calculated for positive emotion (6 items) and negative emotion (6 items) by averaging responses within each set (range: 1 to 5). Higher scores on the positive emotion subscale reflect greater positive mood during the past week, indicating better well-being. Higher scores on the negative emotion subscale reflect greater negative mood, indicating poorer well-being.	T1 (baseline, 1-week pre-intervention), T2 (1-week post-intervention), T3 (1-month post-intervention), T4 (3-months post-intervention)
Mental Health Inventory (MHI) - Changes From Baseline (Adult Child)	The MHI includes 5 items from the longer MHI (McHorney, Ware, & Raczek, 1993) to assess depression, anxiety, and vitality during the past week (completed by older adults and adult children). Items are rated on a 6-point scale: 1 = None of the time, 2 = A little of the time, 3 = Some of the time, 4 = A good bit of the time, 5 = Most of the time, 6 = All of the time. The total score is the average of all 8 items, some reverse-scored (range: 1 to 6). Higher scores indicate better mental health.	T1 (baseline, 1-week pre-intervention), T2 (1-week post-intervention), T3 (1-month post-intervention), T4 (3-months post-intervention)
Perceived Stress Scale (PSS) - Changes From Baseline (Adult Child)	The PSS short form (completed by adult children) is a 4-item scale adapted from the longer PSS (Cohen, Kamarck, & Mermelstein, 1983). Items are rated on a 5-point scale: 1 = Never, 2 = Almost never, 3 = Sometimes, 4 = Fairly often, 5 = Very often. The total score is the average of the 4 items, some reverse-scored (range: 1 to 5). Higher scores indicate greater perceived stress.	T1 (baseline, 1-week pre-intervention), T2 (1-week post-intervention), T3 (1-month post-intervention), T4 (3-months post-intervention)
Caregiver Guilt/Grief Scale - Changes From Baseline (Adult Child)	This scale (completed by adult children) includes 13 items adapted from the caregiver guilt and grief scales (Wells, Jorm, Jordan, & Lefroy, 1990). Items are rated on a 5-point scale: 1= Not at all, 2 = A little, 3 = A moderate amount, 4 = A lot, 5 = Almost unbearably. The total score is the average of the 13 items (range: 1 to 5). Higher scores indicate greater caregiver guilt/grief.	T1 (baseline, 1-week pre-intervention), T2 (1-week post-intervention), T3 (1-month post-intervention), T4 (3-months post-intervention)
Relational Burnout/Load Scale - Changes From Baseline (Adult Child)	Relational burnout/load is assessed with 6 items from the Relational Load Scale (Afifi et al., 2019). (Completed by adult children.) Items are rated on a 5-point scale: 1 = Strongly disagree, 2 = Disagree, 3 = Neutral, 4 = Agree, 5 = Strongly agree. The total score is the average of the 6 items, some reverse-scored (range: 1 to 5). Higher scores indicate a greater sense of relational load/burnout.	T1 (baseline, 1-week pre-intervention), T2 (1-week post-intervention), T3 (1-month post-intervention), T4 (3-months post-intervention)
Unidimensional Relationship Closeness Scale - Changes From Baseline (Adult Child)	Relationship closeness is assessed with 4 items from the Unidimensional Relationship Closeness Scale (Dibble, Levine, & Park, 2011). (Completed by older adults and adult children.) Items are rated on a 7-point scale: 1 = Strongly disagree, 2 = Disagree, 3 = Somewhat disagree, 4 = Neutral, 5 = Somewhat agree, 6 = Agree, 7 = Strong Agree. The total score is the average of the 4 items (range: 1 to 7). Higher scores indicate greater relationship closeness.	T1 (baseline, 1-week pre-intervention), T2 (1-week post-intervention), T3 (1-month post-intervention), T4 (3-months post-intervention)
Relationship Satisfaction - Changes From Baseline (Adult Child)	Global relationship satisfaction is assessed with 3 items adapted from Huston et al.'s (1986) relationship satisfaction scale (completed by older adults and adult children). Items are rated on a 6-point scale: 1 = Not at all, 2 = A little, 3 = Somewhat, 4 = Very, 5 = Almost completely, 6 = Completely. The total score is the average of the 3 items (range: 1 to 6). Higher scores indicate greater relationship satisfaction.	T1 (baseline, 1-week pre-intervention), T2 (1-week post-intervention), T3 (1-month post-intervention), T4 (3-months post-intervention)
Communal Coping - Changes From Baseline (Adult Child)	Communal coping is assessed with 3 items reflecting feelings of unity when combatting stress (Afifi et al., 2019). (Completed by older adults and adult children.) Items are rated on a 5-point scale: 1 = Strongly disagree, 2 = Disagree, 3 = Neutral, 4 = Agree, 5 = Strongly agree. The total score is the average of the 3 items (range: 1 to 5). Higher scores indicate a greater sense of communal coping.	T1 (baseline, 1-week pre-intervention), T2 (1-week post-intervention), T3 (1-month post-intervention), T4 (3-months post-intervention)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Positive and Negative Affect Schedule (PANAS) - Technology Sessions	Positive and negative emotions experienced during the technology session (older adult and adult child). Rated on a scale from 1 to 5, and separate indexes are computed for positive emotion and negative emotion. Higher scores represent greater positive and negative emotion. Scores will be averaged across the intervention period (4 weeks) for overall measures of positive/negative affect experienced during the intervention. Higher positive emotion and lower negative emotion indicate a more favorable response during the technology session.	Immediately after each of the 4 technology sessions during the intervention (one week apart)
Social and Conversational Engagement - Technology Sessions	Social and conversational engagement during the technology sessions will be evaluated using items developed specifically for this study, based on findings from a pilot study. Higher scores indicate greater engagement. Engagement scores will be averaged over the four-week intervention period to generate an overall engagement measure. In addition to self-reports, objective coders will analyze video and audio recordings of the sessions to assess conversational and emotional engagement. Kinesic (physical) engagement of the older adult will be evaluated both by trained raters and an automated computer program.	Immediately after each of the 4 technology sessions during the intervention (one week apart)
Relationship Satisfaction and Communication Quality - Technology Sessions	Multiple items designed to assess features of relationship quality (older adult and adult child). Higher scores represent greater satisfaction and communication quality. Scores will be averaged across the intervention period (4 weeks) for an overall score of relationship satisfaction and communication quality during the technology sessions, during the intervention period.	Immediately after each of the 4 technology sessions during the intervention (one week apart)
Telepresence and Copresence - Technology Session	Rating of engagement and immersion during the technology session (older adult and adult child). Items were written for this project based on a pilot study. Higher scores represent greater telepresence and co-presence. Due to time limitations, this measure is completed only during the first technology session.	Measured after the first technology session (Week 1 of the intervention)

Collaborators and Investigators

• Sponsor: University of California, Santa Barbara
• Collaborators: National Institute on Aging (NIA); Rendever, Inc.
• Investigators: Principal Investigator: Tamara Afifi, PhD, University of California, Santa Barbara; Principal Investigator: Kyle Rand, B.A., Rendever Co.; Principal Investigator: Nancy Collins, PhD, University of California, Santa Barbara

Study record dates

Study Major Dates

• Study Start (Actual): October 2, 2021
• Primary Completion (Actual): March 16, 2024
• Study Completion (Actual): March 16, 2024

Study Registration Dates

• First Submitted: October 28, 2021
• First Submitted That Met QC Criteria: November 26, 2021
• First Posted (Actual): December 9, 2021

Study Record Updates

• Last Update Posted (Actual): July 15, 2025
• Last Update Submitted That Met QC Criteria: June 25, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Quality of Life; Dementia; Caregiver burden; Loneliness; Cognitive impairment; Mental health; Older adults; Virtual reality; Seniors; Technology; Thriving; Assisted living; Social connection; Video chat (Zoom); Senior living community; Caregiver guilt; Family relationships; Adult children
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Behavioral Symptoms; Neurocognitive Disorders; Tauopathies; Neurodegenerative Diseases; Stress, Psychological; Caregiver Burden; Alzheimer Disease; Dementia
• Other Study ID Numbers: NIH 13336607; R42AG063640-02 (U.S. NIH Grant/Contract); 3R42AG063640-03S1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Deidentified data and related information will be made available to researchers and data analysts at no cost through NACDA-Open Aging Repository (NACDA-OAR), which is an NIH-funded repository. Quantitative data, codebooks, descriptions of missing data, and any errors will be made available on the site. The data submitted will conform to the NACDA-OAR standards.
• IPD Sharing Time Frame: Deidentified data and related files will be made available in the NACDA-OAR repository no later than within one year of the completion of the funded project period or upon the first publication of the data online. Data will be posted indefinitely.
• IPD Sharing Access Criteria: Data will be deposited and made available through NACDA-Open Aging Repository (NACDA-OAR) and will be shared with investigators working under an institution with a Federal Wide Assurance (FWA). Data can be used for secondary study purposes. Users will be required to register on the password-protected site in order to access the data files, which includes agreeing to the conditions of use related to the public release of the data. This includes not using any identifying information, ethical reporting, not selling the data to third parties, acknowledging the data source, and destroying the data upon use.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No