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

NCT ID: NCT03124550

Last Updated: 2020-10-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-11
• Study Completion Date: 2019-09-20

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.

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.

Conditions

Sedentary Lifestyle; Stress, Psychological

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Exergame Experience

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

Brandeis University

OTHER

Sponsor Role: lead

Responsible Party

Margie Lachman

Professor of Psychology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Margie Lachman, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Brandeis University

Locations

Northeastern University

Boston, Massachusetts, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

5P30AG048785

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Exergame #17065

Identifier Type: -

Identifier Source: org_study_id