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Development of An Exergame for Caregivers of Individuals With Alzheimer's Disease or Related Dementias

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ClinicalTrials.gov Identifier: NCT03124550
Recruitment Status : Recruiting
First Posted : April 24, 2017
Last Update Posted : January 11, 2019
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Margie Lachman, Brandeis University

Brief Summary:
The study goal is to evaluate user experience with our developed exergame, which was designed to increase physical activity, exercise self-efficacy, and social connections among caregivers of individuals with Alzheimer's disease (AD) or related dementias. Participants will use this garden-themed exergame for six weeks. Tailoring an exergame for caregivers of AD or related dementias has the potential to increase physical activity and to improve overall health and well-being in this vulnerable population, which in turn can benefit the patients for whom they provide care. All study sessions be held at a location convenient to participants. Interested participants can fill out the link below (under detailed description) to sign up.

Condition or disease Intervention/treatment Phase
Sedentary Lifestyle Stress, Psychological Behavioral: Exergame Experience Not Applicable

Detailed Description:

The number of Alzheimer's Disease (AD) caregivers providing informal care for family members is rising dramatically, and supportive programs are vitally needed. Caregivers of AD patients have relatively high levels of stress and depression and limited physical activity and social engagement. Technology-driven programs can offer engaging, sustainable, and scalable opportunities to give caregivers critically-needed supports for health and well- being. This pilot study uses cognitive behavioral methods to develop an innovative social exergame to increase physical and social activity among AD caregivers. Leveraging wearable activity monitors, physical activity data collected throughout the day and in varied settings will serve as input to the game experience.

Caregivers will assess the suitability of an exergame prototype with an array of features including (1) instructional exercise modules, (2) activity data visualizations, (3) digital rewards for physical activity that can be used to create virtual gardens, and (4) opportunities to connect virtually with other caregivers to share and comment on their creative products.

The aim of this study is to evaluate enjoyment of the exergame and its feasibility to increase moderate and vigorous physical activity, virtual social contact, and exercise self-efficacy. A group of approximately 20 caregivers will test the exergame for six weeks on an Android smartphone. The findings will be used to develop larger-scale intervention studies to test the efficacy of the exergame in the future. Tailoring an exergame for caregivers of AD has the potential to increase physical activity and to improve overall health and well-being in this vulnerable population, which in turn can benefit the Alzheimer's patients for whom they provide care.

All participants will be given a fitness tracker to keep after the study, a value of over $100! Participants will receive $5 Amazon Gift card each week upon completion of each weekly questionnaire. Participants can receive up to a $30 of Amazon Gift card upon completion of weekly questionnaire. In addition, all study sessions will be held at a location convenient to participants within the above regions.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Participants will use the exergame for 4 weeks Physical activity will be recorded. Participants will receive game-related rewards when they are active.
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Development of An Exergame for Caregivers of Individuals With Alzheimer's Disease or Related Dementias
Actual Study Start Date : May 11, 2017
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : July 2020


Arm Intervention/treatment
Experimental: Exergame Experience
Participants will use the exergame for 6 weeks, during which time game telemetry data (all interactions with the software) will be automatically logged by the system. The participants will be asked to use the game at least every other day. Caregivers will be sent an email or text message to remind them to use the system if they have not done so within three days. Utilizing two-way text messaging, an experience sampling protocol ¬will be employed: once per week, participants will be sent brief questions probing their level of satisfaction with the exergame and their level of perceived connectedness to the community of other caregivers using the exergame.
Behavioral: Exergame Experience

Behavioral: Exergame Experience

Fitbit Charge HR will be used to measure physical activity and sedentary behavior during waking hours. Each participant will wear a Fitbit for a period of one week at baseline and during the entire 6-week pilot study. Data on step counts, heart rate, and moderate/vigorous activity from the Fitbits will be transmitted wirelessly to our secure research server and will be used to assess changes in physical activity and sedentary behavior over the course of the study. Participants will be instructed to wear the monitor continuously on the wrist. Data will be analyzed using previously validated accelerometer count cut-points for adults after accounting for invalid data and wear time.





Primary Outcome Measures :
  1. Number of steps [ Time Frame: Daily for four weeks ]
    Average walking step count from Fitbit


Secondary Outcome Measures :
  1. Exercise Intensity [ Time Frame: Daily for four weeks ]
    Average time in moderate or vigorous activity from Fitbit

  2. Exercise self-efficacy [ Time Frame: After four week intervention ]
    Average amount of confidence in ability to exercise

  3. Number of social contacts [ Time Frame: Monitored during the four week intervention ]
    Average number of virtual interactions with other caregivers using the exergame



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

  • Be 18 years or older
  • Be a caregiver who spends a significant amount of time with a family member, partner, or friend with Alzheimer's Disease or related dementias.
  • Be able to walk for at least 20 minutes at a time
  • Have regular access to an Android smartphone with Internet access
  • Be comfortable wearing a fitness tracker for the duration of the study
  • Must be located in Massachusetts, New Hampshire, Rhode Island, Connecticut, or New York City

Exclusion Criteria:

  • A recent (within the past 6 months) cardiovascular event or fall.
  • A score on the Short Portable Mental Status Questionnaire (SPMSQ) that indicates intellectual impairment.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03124550


Contacts
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Contact: Elizabeth Res. Asst., B.A. 617-373-6347 WellnessTechLab@gmail.com
Contact: Andrea Parker, Ph.D. 617-373-6347 WellnessTechLab@gmail.com

Locations
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United States, Massachusetts
Northeastern University Recruiting
Boston, Massachusetts, United States, 02115
Contact: Elizabeth Research Asst., BA    617-373-6347    WellnessTechLab@gmail.com   
Contact: Andrea Parker, Ph.D.    617-373-6347    WellnessTechLab@gmail.com   
Sponsors and Collaborators
Brandeis University
National Institute on Aging (NIA)
Investigators
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Principal Investigator: Margie Lachman, Ph.D. Brandeis University

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Responsible Party: Margie Lachman, Professor of Psychology, Brandeis University
ClinicalTrials.gov Identifier: NCT03124550     History of Changes
Other Study ID Numbers: Exergame #17065
5P30AG048785 ( U.S. NIH Grant/Contract )
First Posted: April 24, 2017    Key Record Dates
Last Update Posted: January 11, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Margie Lachman, Brandeis University:
Caregivers
Exercise
Behavior Change

Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Stress, Psychological
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Behavioral Symptoms