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
|Condition or disease||Intervention/treatment||Phase|
|Sedentary Lifestyle Stress, Psychological||Behavioral: Exergame Experience||Not Applicable|
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.
|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|
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.
- Number of steps [ Time Frame: Daily for four weeks ]Average walking step count from Fitbit
- Exercise Intensity [ Time Frame: Daily for four weeks ]Average time in moderate or vigorous activity from Fitbit
- Exercise self-efficacy [ Time Frame: After four week intervention ]Average amount of confidence in ability to exercise
- Number of social contacts [ Time Frame: Monitored during the four week intervention ]Average number of virtual interactions with other caregivers using the exergame
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
|Contact: Elizabeth Res. Asst., B.A.||617-373-6347||WellnessTechLab@gmail.com|
|Contact: Andrea Parker, Ph.D.||617-373-6347||WellnessTechLab@gmail.com|
|United States, Massachusetts|
|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|
|Principal Investigator:||Margie Lachman, Ph.D.||Brandeis University|