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

Stress, Psychological Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03124550
• Other study ID #: Exergame #17065
• Secondary ID: 5P30AG048785
• Status: Completed
• Phase: N/A
• Start date: May 11, 2017
• Est. completion date: September 20, 2019

Study information

• Verified date: September 2020
• Source: Brandeis University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: September 20, 2019
• Est. primary completion date: August 6, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Alzheimer Disease
• Dementia
• Sedentary Lifestyle
• Stress, Psychological

Intervention

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.

Locations

Country	Name	City	State
United States	Northeastern University	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Brandeis University	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Steps	Number of steps recorded daily from the Fitbit, weekly step averages	Daily for six weeks
Secondary	Caregiver's Management of Distress	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.	Baseline (pretest) and 6 weeks from the start of the intervention (posttest)
Secondary	Exercise Self-efficacy	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).	Baseline (pretest) and 6 weeks from the start of the intervention (posttest)
Secondary	Number of Social Contacts	Average daily number of social contacts with other caregivers using the exergame in a week	Daily for six weeks