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

NCT03124550 | Completed Results

• 2 other identifiers: Exergame #170655P30AG048785
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Sedentary Lifestyle; Stress, Psychological

Keywords

Caregivers; Exercise; Behavior Change

Outcome Measures

Primary Outcomes (1)

• Number of Steps

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

  Daily for six weeks

Secondary Outcomes (3)

• Caregiver's Management of Distress

  Baseline (pretest) and 6 weeks from the start of the intervention (posttest)

• Exercise Self-efficacy

  Baseline (pretest) and 6 weeks from the start of the intervention (posttest)

• Number of Social Contacts

  Daily for six weeks

Study Arms (1)

Exergame Experience

EXPERIMENTAL

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

Interventions

Exergame Experience BEHAVIORAL

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.

Exergame Experience

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Brandeis University: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Northeastern University

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Sedentary Behavior; Stress, Psychological; Motor Activity

Condition Hierarchy (Ancestors)

Behavior; Behavioral Symptoms

Results Point of Contact

• Title: Dr. Margie E. Lachman
• Organization: Brandeis University

lachman@brandeis.edu

7817363255

Study Officials

• Margie Lachman, Ph.D.

  Brandeis University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychology

Model Details: Participants will use the exergame for 6 weeks. Physical activity will be recorded. Participants will receive game-related rewards when they are active.

Study Record Dates

• First Submitted: April 13, 2017
• First Posted: April 24, 2017
• Study Start: May 11, 2017
• Primary Completion: August 6, 2019
• Study Completion: September 20, 2019
• Last Updated: October 22, 2020
• Results First Posted: October 22, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)