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

• ClinicalTrials.gov Identifier: NCT03124550
• Recruitment Status: Completed
• First Posted: April 24, 2017
• Results First Posted: October 22, 2020
• Last Update Posted: October 22, 2020
• Sponsor: Brandeis University
• Collaborator: National Institute on Aging (NIA)
• Information provided by (Responsible Party): Margie Lachman, Brandeis University

Study Description

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.

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 18 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: Participants will use the exergame for 6 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
• Actual Primary Completion Date: August 6, 2019
• Actual Study Completion Date: September 20, 2019

Arms and Interventions

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; 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.

Outcome Measures

Primary Outcome Measures :

1. Number of Steps [ Time Frame: Daily for six weeks ]
   Number of steps recorded daily from the Fitbit, weekly step averages

Secondary Outcome Measures :

1. Caregiver's Management of Distress [ Time Frame: Baseline (pretest) and 6 weeks from the start of the intervention (posttest) ]
   Caregiver's management of distress was measured with the amount of time caregivers spent on themselves doing leisure activities when they were under stress from caregiving. Answer choices ranged from never (1) to very often (4). A higher score indicated better management of distress.
2. Exercise Self-efficacy [ Time Frame: Baseline (pretest) and 6 weeks from the start of the intervention (posttest) ]
   A modified version of Bandura's Exercise Self-Efficacy scale (Bandura, 1997) was used in the current study. This 8-item scale assesses how sure one is that they would exercise under different conditions or constraints (e.g. How sure are you that you will exercise when you are feeling down or depressed?), with answer choices ranging from not sure at all (1) to very sure (4). The 8 items are averaged to create a composite score, where a higher score indicates greater exercise self-efficacy (Neupert et al., 2009).
3. Number of Social Contacts [ Time Frame: Daily for six weeks ]
   Average daily number of social contacts with other caregivers using the exergame in a week

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (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.

Contacts and Locations

Locations

United States, Massachusetts

Northeastern University

Boston, Massachusetts, United States, 02115

Sponsors and Collaborators

Brandeis University

National Institute on Aging (NIA)

Investigators

• Principal Investigator: Margie Lachman, Ph.D.; Brandeis University

  Study Documents (Full-Text)

Documents provided by Margie Lachman, Brandeis University:

Informed Consent Form  [PDF] March 16, 2019

Study Protocol and Statistical Analysis Plan  [PDF] September 20, 2019

More Information

• Responsible Party: Margie Lachman, Professor of Psychology, Brandeis University
• ClinicalTrials.gov Identifier: NCT03124550
• Other Study ID Numbers: Exergame #17065; 5P30AG048785 ( U.S. NIH Grant/Contract )
• First Posted: April 24, 2017
• Results First Posted: October 22, 2020
• Last Update Posted: October 22, 2020
• Last Verified: September 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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:

Alzheimer Disease; Dementia; Stress, Psychological; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Behavioral Symptoms