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

Not Applicable

Completed

• Conditions: Stress, Psychological; Sedentary Lifestyle
• Interventions: Behavioral: Exergame Experience

• Registration Number: NCT03124550
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2017-04-13
• Study First Submitted QC: 2017-04-19
• Study First Posted: 2017-04-24
• Study Start: 2017-05-11
• Primary Completion: 2019-08-06
• Study Completion: 2019-09-20
• Results First Submitted: 2020-08-17
• Status Verified: 2020-09
• Results First Submitted QC: 2020-09-30
• Last Update Submitted: 2020-09-30
• Results First Posted: 2020-10-22
• Last Update Posted: 2020-10-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Exergame Experience	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.

Primary Outcome Measures

Name	Time	Method
Number of Steps	Daily for six weeks	Number of steps recorded daily from the Fitbit, weekly step averages

Secondary Outcome Measures

Name	Time	Method
Caregiver's Management of Distress	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.
Exercise Self-efficacy	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).
Number of Social Contacts	Daily for six weeks	Average daily number of social contacts with other caregivers using the exergame in a week

Trial Locations

Locations (1)

Northeastern University; 🇺🇸 Boston, Massachusetts, United States