Clinical trial NCT03124550: Development of An Exergame for Caregivers of Individuals With Alzheimer's Disease or Related Dementias
Official title: Development of An Exergame for Caregivers of Individuals With Alzheimer's Disease or Related Dementias
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sedentary Lifestyle
Stress, Psychological
Keywords: Caregivers
Exercise
Behavior Change
Lead sponsor: Brandeis University
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2017-04-24
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Number of Steps
timeFrame: Daily for six weeks
Secondary outcomes:
measure: Caregiver's Management of Distress
timeFrame: Baseline (pretest) and 6 weeks from the start of the intervention (posttest)
measure: Exercise Self-efficacy
timeFrame: Baseline (pretest) and 6 weeks from the start of the intervention (posttest)
measure: Number of Social Contacts
timeFrame: Daily for six weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Northeastern University
state: Massachusetts
Study officials:
affiliation: Brandeis University
name: Margie Lachman, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: