Trial Outcomes & Findings for Development of An Exergame for Caregivers of Individuals With Alzheimer's Disease or Related Dementias (NCT NCT03124550)

NCT ID: NCT03124550

Last Updated: 2020-10-22

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 18 participants
• Primary outcome timeframe: Daily for six weeks
• Results posted on: 2020-10-22

Participant Flow

Participant milestones

Measure	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.
Overall Study STARTED	18
Overall Study COMPLETED	18
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Exergame Experience n=18 Participants 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.
Age, Continuous	49 years STANDARD_DEVIATION 15 • n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	16 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	5 Participants n=5 Participants
Race (NIH/OMB) White	8 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Region of Enrollment United States	18 participants n=5 Participants
Education Less Than 7th Grade	0 Participants n=5 Participants
Education Junior high/middle school	0 Participants n=5 Participants
Education Some high school	2 Participants n=5 Participants
Education Completed high school or GED	4 Participants n=5 Participants
Education Some college or Vocational training	1 Participants n=5 Participants
Education Completed 2 years of college, Associate Degree	1 Participants n=5 Participants
Education Completed 4 years college, College Degree	7 Participants n=5 Participants
Education Completed graduate school degree	3 Participants n=5 Participants
Care Recipient Parent	10 Participants n=5 Participants
Care Recipient Other family members	6 Participants n=5 Participants
Care Recipient Friend	2 Participants n=5 Participants
Age of Care Recipient	80 years STANDARD_DEVIATION 8 • n=5 Participants
Caregiving Length	45 Months STANDARD_DEVIATION 33 • n=5 Participants
Caregiving Time	5 Days per Week STANDARD_DEVIATION 2 • n=5 Participants

PRIMARY outcome

Timeframe: Daily for six weeks

Population: Daily step averages less than 500 steps were classified as a missing day of data. Weekly step averages were calculated for weeks with 4 or more days of valid data.

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

Outcome measures

Measure	Exergame Experience n=18 Participants 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.
Number of Steps Week 1	8857 Daily Steps Standard Deviation 5132
Number of Steps Week 2	8179 Daily Steps Standard Deviation 4263
Number of Steps Week 3	8659 Daily Steps Standard Deviation 5280
Number of Steps Week 4	7867 Daily Steps Standard Deviation 5428
Number of Steps Week 5	6554 Daily Steps Standard Deviation 4301
Number of Steps Week 6	6837 Daily Steps Standard Deviation 4413

SECONDARY outcome

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

Population: Because of participant family emergencies, one of the participant did not get to complete the posttest. Therefore, we missed the pre and post test comparison for one participant.

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.

Outcome measures

Measure	Exergame Experience n=17 Participants 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.
Caregiver's Management of Distress Pre-test	2.1 units on a scale Standard Deviation .39
Caregiver's Management of Distress Post-test	2.4 units on a scale Standard Deviation .30

SECONDARY outcome

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

Population: Because of participant family emergencies, one of the participant did not get to complete the posttest. Therefore, we missed the pre and post test comparison for one participant. Another participant did not fill out the pretest for the exercise self-efficacy section. Thus, we only analyzed 16 participants for 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).

Outcome measures

Measure	Exergame Experience n=16 Participants 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.
Exercise Self-efficacy Pre-test	2.59 units on a scale Standard Deviation 1.02
Exercise Self-efficacy Post-test	2.61 units on a scale Standard Deviation 1.06

SECONDARY outcome

Timeframe: Daily for six weeks

Population: Social contact is measured daily by the sum of number of times participants viewed, liked, added, and replied to stories, and viewed other caregivers' gardens.

Average daily number of social contacts with other caregivers using the exergame in a week

Outcome measures

Measure	Exergame Experience n=18 Participants 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.
Number of Social Contacts Week 1	5.7 Daily number of social contact Standard Deviation 7.4
Number of Social Contacts Week 2	4.8 Daily number of social contact Standard Deviation 5.0
Number of Social Contacts Week 3	4.7 Daily number of social contact Standard Deviation 5.1
Number of Social Contacts Week 4	3.7 Daily number of social contact Standard Deviation 4.6
Number of Social Contacts Week 5	3.9 Daily number of social contact Standard Deviation 7.2
Number of Social Contacts Week 6	3.4 Daily number of social contact Standard Deviation 6.2

Adverse Events

Exergame Experience

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Margie E. Lachman

Brandeis University

Phone: 7817363255

Email: lachman@brandeis.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place