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

Primary Purpose

Sedentary Lifestyle, Stress, Psychological

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exergame Experience
Sponsored by
Brandeis University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Sedentary Lifestyle focused on measuring Caregivers, Exercise, Behavior Change

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Northeastern University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Exergame Experience

Arm Description

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.

Outcomes

Primary Outcome Measures

Number of Steps
Number of steps recorded daily from the Fitbit, weekly step averages

Secondary Outcome Measures

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.
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).
Number of Social Contacts
Average daily number of social contacts with other caregivers using the exergame in a week

Full Information

First Posted
April 13, 2017
Last Updated
September 30, 2020
Sponsor
Brandeis University
Collaborators
National Institute on Aging (NIA)
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1. Study Identification

Unique Protocol Identification Number
NCT03124550
Brief Title
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

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
May 11, 2017 (Actual)
Primary Completion Date
August 6, 2019 (Actual)
Study Completion Date
September 20, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brandeis University
Collaborators
National Institute on Aging (NIA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sedentary Lifestyle, Stress, Psychological
Keywords
Caregivers, Exercise, Behavior Change

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exergame Experience
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Exergame Experience
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Steps
Description
Number of steps recorded daily from the Fitbit, weekly step averages
Time Frame
Daily for six weeks
Secondary Outcome Measure Information:
Title
Caregiver's Management of Distress
Description
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.
Time Frame
Baseline (pretest) and 6 weeks from the start of the intervention (posttest)
Title
Exercise Self-efficacy
Description
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).
Time Frame
Baseline (pretest) and 6 weeks from the start of the intervention (posttest)
Title
Number of Social Contacts
Description
Average daily number of social contacts with other caregivers using the exergame in a week
Time Frame
Daily for six weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Margie Lachman, Ph.D.
Organizational Affiliation
Brandeis University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northeastern University
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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