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| ID | Type | Description | Link |
|---|---|---|---|
| 5P30AG048785 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
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| National Institute on Aging (NIA) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Steps | Number of steps recorded daily from the Fitbit, weekly step averages | Daily for six weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Margie Lachman, Ph.D. | Brandeis University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northeastern University | Boston | Massachusetts | 02115 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Steps | Number of steps recorded daily from the Fitbit, weekly step averages | 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. | Posted | Mean | Standard Deviation | Daily Steps | Daily for six weeks |
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6 weeks
Participants were asked to report any adverse events to the investigator throughout the study
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Margie E. Lachman | Brandeis University | 7817363255 | lachman@brandeis.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Mar 16, 2019 | Aug 12, 2020 | ICF_000.pdf |
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 20, 2019 | Sep 7, 2020 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D057185 | Sedentary Behavior |
| D013315 | Stress, Psychological |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D001526 | Behavioral Symptoms |
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Participants will use the exergame for 6 weeks. Physical activity will be recorded. Participants will receive game-related rewards when they are active.
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| 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) |
| Number of Social Contacts | Average daily number of social contacts with other caregivers using the exergame in a week | Daily for six weeks |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Education | Count of Participants | Participants |
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| Care Recipient | Count of Participants | Participants |
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| Age of Care Recipient | Mean | Standard Deviation | years |
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| Caregiving Length | Mean | Standard Deviation | Months |
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| Caregiving Time | Mean | Standard Deviation | Days per Week |
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| 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline (pretest) and 6 weeks from the start of the intervention (posttest) |
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| 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). | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline (pretest) and 6 weeks from the start of the intervention (posttest) |
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| Secondary | Number of Social Contacts | Average daily number of social contacts with other caregivers using the exergame in a week | 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. | Posted | Mean | Standard Deviation | Daily number of social contact | Daily for six weeks |
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