- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05032872
Exergame Study for Family Caregivers
Social Exergame Intervention to Promote Physical Activity, Social Support, And Well-Being in Family Caregivers
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Massachusetts
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Waltham, Massachusetts, United States, 02453
- Brandeis University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Participants who are caregivers for a family member (e.g., relative, spouse, friend) who is 65 years or older and is either frail, has a disability, or has at least one chronic illness
- 40 years or older
- Own an Android smartphone with Google play store/internet access
- Able to walk for at least 20 minutes at a time
- Comfortable wearing a fitness tracker for the duration of the study
- Familiar with smartphone app usages
- Comfortable with using the study-related app for the duration of the study
Exclusion Criteria:
- Had a recent (within the past 6 months) cardiovascular event or fall.
- Currently participating in any other physical activity study/intervention
- Currently own or use a Fitbit or other activity tracking watches
- Knows someone who is participating or has participated in the study
- Currently physically active (exercise regularly 3 times a week or more for at least 30 minutes)
- More than 2 errors on the Short Portable Mental Status Questionnaire (Pfeiffer, 1975).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Social Exergame Treatment Group
The treatment group will wear a Fitbit step counter for 8 weeks.
In addition, participants will use the full version of the Go&Grow fitness app for 6 weeks.
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Active Comparator: Control Group
The control group will wear a Fitbit step counter for 8 weeks.
In addition, participants will use the Go&Grow fitness app without the social features for 6 weeks.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percent Change in Steps
Time Frame: Percent Change of Steps from baseline to Weeks 3, 4, 5, 6, 7, and 8
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Steps were automatically synced from the Fitbit for both conditions daily. Days with 500 or fewer recorded steps were coded as missing. Weekly step averages were calculated for weeks with 4 or more days not coded missing. The first two weeks of baseline steps were averaged to form the baseline step. Percent change of steps was calculated as the difference between the average weekly steps during the intervention (weeks 3-8) and baseline steps divided by baseline steps. |
Percent Change of Steps from baseline to Weeks 3, 4, 5, 6, 7, and 8
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Lubben Social Network Scale (LSNS)
Time Frame: Pretest (before week 1) and posttest (after week 8)
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Self-report measure of social support from the Lubben Social Network Scale for family and friends with scores summed across 18 items.
Possible scores range from 0-60, with higher scores indicating higher social support.
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Pretest (before week 1) and posttest (after week 8)
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Social Connectedness Scale
Time Frame: Baseline (Average of Week 1 and 2), Weekly during the intervention from Week 3 to 8
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Social Connectedness Scale was administered weekly during the intervention with the following subscales: relationship salience, shared understandings, knowing other's experiences, satisfaction with the contact quantity and quality, and dissatisfaction with contact quantity. Scores were averaged across items from each subscale and possible scores ranged from 1 to 7 with higher scores indicating a higher level of the subscale. |
Baseline (Average of Week 1 and 2), Weekly during the intervention from Week 3 to 8
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UCLA Loneliness Scale
Time Frame: Pretest (before week 1) and posttest (after week 8)
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The UCLA Loneliness Scale captures one's subjective feelings of loneliness over the past week for weekly surveys and over the past month for pretest and posttest surveys (20 items with ratings from 1 "Never" to 4 "Often").
The scores were averaged across the 20 items, with a score ranging from 1-4.
A higher score indicates more loneliness.
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Pretest (before week 1) and posttest (after week 8)
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Positive and Negative Affect Schedule (PANAS) (20 Items)
Time Frame: Pretest (before week 1) and posttest (after week 8)
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Positive and Negative Affect Schedule (PANAS) (20 items) asks participants to report how often participants felt positive and negative feelings over the past week for weekly surveys, and over the past month for pre-test and post-test surveys.
Scores were averaged across the items (Total positive and negative affect scores can range from 0-4, with a higher score indicating a higher level of positive affect or negative affect).
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Pretest (before week 1) and posttest (after week 8)
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Perceived Stress Scale (PSS)
Time Frame: Pretest (before week 1) and posttest (after week 8)
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Perceived Stress Scale (PSS) asks participants' stress perception over the last month and scores were summed across the items (Possible scores range from 0 to 40 with higher scores indicating higher stress).
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Pretest (before week 1) and posttest (after week 8)
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Brief Symptom Inventory (BSI)
Time Frame: Baseline (Average of Week 1 and 2), Weekly during the intervention from Week 3 to 8
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Brief Symptom Inventory (BSI) captures participants' psychological distress over the past week, scores were summed across the items (Total score ranges from 0-72, with higher scores indicating more stress) (Derogatis, 1975).
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Baseline (Average of Week 1 and 2), Weekly during the intervention from Week 3 to 8
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Caregiver's Stress Scale
Time Frame: Pretest (before week 1) and posttest (after week 8)
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Caregiver's Stress Scale has a series of subscales based on a conceptual model of caregivers' stress: overload, relational deprivation, job and caregiving conflict, role captivity, sense of self, caregiving competence, personal gain, management of situation, management of meaning, management of distress, and expressive support.
Each subscale ranges from 1 (strongly disagree) to 4 (strongly agree), and each subscale was averaged (with possible score ranging from 1-4) so that higher scores would indicate a higher value.
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Pretest (before week 1) and posttest (after week 8)
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International Physical Activity Questionnaire (IPAQ) Short Version
Time Frame: Pretest (before week 1) and posttest (after week 8)
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International Physical Activity Questionnaire - Short Version.
A continuous score was calculated expressed as MET (Metabolic Equivalents) minutes per week: Total MET-min/week = (Walk METs*min*days) + (Mod METs*min*days) + Vig METs*min*days).
A higher score means a higher level of physical activity.
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Pretest (before week 1) and posttest (after week 8)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Exercise Self-Efficacy
Time Frame: Pretest (before week 1) and posttest (after week 8)
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9 items assessed how certain participants will exercise under certain circumstances (e.g., when you are feeling under pressure or when you are away from home).
Items are assessed from 1 (very sure) to 4 (not at all sure).
Items were reverse coded and summed across all items with a score ranging from 9 to 36.
A higher score indicates higher exercise self-efficacy.
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Pretest (before week 1) and posttest (after week 8)
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Satisfaction With Life Scale
Time Frame: Pretest (before week 1) and posttest (after week 8)
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Items are assessed from 1 (disagree strongly) to 7 (agree strongly) summed across all items, ranging from 5-35.
A higher score indicates a higher satisfaction with life.
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Pretest (before week 1) and posttest (after week 8)
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Sense of Control
Time Frame: Pretest (before week 1) and posttest (after week 8)
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items were used to assess sense of control.
For example: "There is little I can do to change many of the important things in my life."
Items are assessed from 1 (strongly disagree) to 7 (strongly agree) and reverse coded.
A sum across all items was calculated ranging from 6-42.
A higher score indicates a higher sense of control.
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Pretest (before week 1) and posttest (after week 8)
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Exergame Enjoyment Questionnaire (EEQ)
Time Frame: Posttest (after week 8)
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Exergame Enjoyment Questionnaire (EEQ) was included in the posttest, which measured how much participants enjoyed the exergame (Fitzgerald et al., 2020).
20 items ranged from strongly disagree (1) to strongly agree (5) were summed.
Scores rannged from 20 - 100, with a higher score indicating more exergame enjoyment.
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Posttest (after week 8)
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Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- GoGrowExergrame #20104R
- P30AG048785 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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