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| ID | Type | Description | Link |
|---|---|---|---|
| 3R21AG052838-02S1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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The purpose of this study is to develop and test a physical activity-tracking smartphone app designed to facilitate physical activity in older adults with mild cognitive impairments or mild dementia. The app targets provides tips, messages, and strategies to overcome common barriers older adults face to being physically active. Participants will include older adults with memory or thinking problems or those diagnosed with mild cognitive impairment or mild forms of dementia who are smartphone users age 65 years or older and who are not meeting nationally recommended levels of physical activity. In the clinical trial phase of this study, 15 participant-study partner dyads will be oriented to the app and use it for a two-month period. Dyads will keep a diary to document their experiences and participants' activity patterns will also be tracked at the beginning and end of the study. After the two-month app trial is complete, dyads will return for a follow-up interview to discuss their experiences and provide suggestions for app improvements. Findings from this stage of the overall study will be combined with previous study phases to derive specifications for an optimized app for older people with mild cognitive impairments or mild dementia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Target Users - Moving Up-A app | Other | In this single-arm trial, target users (participants) will use a physical activity smartphone app for a two-month period. The app includes motivational messages, tips to increase the intensity level of everyday activities, and strategies to reduce sedentary behaviors. Users can also track their physical activity levels and sedentary activity. |
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| Study Partners - Moving Up-A app | Other | In this single-arm trial, study partners were invited to support target users (participants) in using a physical activity smartphone app for a two-month period. The app includes motivational messages, tips to increase the intensity level of everyday activities, and strategies to reduce sedentary behaviors. Users can also track their physical activity levels and sedentary activity. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Moving Up - A | Behavioral | Moving Up - A is a physical activity smartphone app for persons with mild cognitive impairment or mild forms of dementia. The app includes a personally tailored set of messages, tips, strategies, and tasks designed to increase physical activity levels and disrupt extended periods of sedentary time. Users also have the ability to track their steps and and sedentary behavior time as well as their progress towards activity goals. |
| Measure | Description | Time Frame |
|---|---|---|
| Daily Steps Change From Baseline to Month 2 | Step counts (objective physical activity) were measured using the activPAL thigh-worn accelerometer during a 96-hour monitoring period. Change is computed as the activPAL-tracked mean daily steps at Month 2 minus that value at baseline | baseline and 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| Daily Sitting Time (activPAL) Change From Baseline to Month 2 | Objective sedentary activity time was measured using the activPAL thigh-worn accelerometer during a 96-hour monitoring period. Expressed as average minutes/day. Change is computed as the activPAL-tracked mean minutes/day of sitting time at Month 2 minus that value at baseline. | baseline and 2 months |
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Inclusion Criteria - Target User:
Exclusion Criteria - Target User:
Inclusion Criteria - Study Partner:
Note: age limit criterion for target users does not apply to study partners
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Southern California | Los Angeles | California | 90089-9003 | United States |
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59 target users screened for eligibility; 15 signed consent; 15 completed the 2-month trial and included in analyses.
6 study partners were screened for eligibility; 6 signed consent; 6 completed their role in the study. Only limited baseline analyses regarding characteristics were included.
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| ID | Title | Description |
|---|---|---|
| FG000 | Target Users - Moving Up-A App | In this single-arm trial, participants will use a physical activity smartphone app for a two-month period. The app includes motivational messages, tips to increase the intensity level of everyday activities, and strategies to reduce sedentary behaviors. Users can also track their physical activity levels and sedentary activity. Moving Up - A: Moving Up - A is a physical activity smartphone app for persons with mild cognitive impairment or mild forms of dementia. The app includes a personally tailored set of messages, tips, strategies, and tasks designed to increase physical activity levels and disrupt extended periods of sedentary time. Users also have the ability to track their steps and and sedentary behavior time as well as their progress towards activity goals. |
| FG001 | Study Partners - Moving Up-A App | Study partners: target users (participants) were invited to have a study partner (friend, family, caregiver) to support use of the Moving Up-A app by the target users. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Target users' data were primarily collected and analyzed for this study. Only limited baseline data relevant to the study partners was collected and analyzed.
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| ID | Title | Description |
|---|---|---|
| BG000 | 2-month Pilot Test - Target Users | In this single-arm trial, participants will use a physical activity smartphone app for a two-month period. The app includes motivational messages, tips to increase the intensity level of everyday activities, and strategies to reduce sedentary behaviors. Users can also track their physical activity levels and sedentary activity. Moving Up - A: Moving Up - A is a physical activity smartphone app for persons with mild cognitive impairment or mild forms of dementia. The app includes a personally tailored set of messages, tips, strategies, and tasks designed to increase physical activity levels and disrupt extended periods of sedentary time. Users also have the ability to track their steps and and sedentary behavior time as well as their progress towards activity goals. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Only target user (not study partner) data were collected and analyzed for this baseline measure. |
| 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 | Daily Steps Change From Baseline to Month 2 | Step counts (objective physical activity) were measured using the activPAL thigh-worn accelerometer during a 96-hour monitoring period. Change is computed as the activPAL-tracked mean daily steps at Month 2 minus that value at baseline | Posted | Mean | Standard Deviation | steps per day | baseline and 2 months |
|
2 months
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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 | Target Users - Moving Up-A App | In this single-arm trial, participants will use a physical activity smartphone app for a two-month period. The app includes motivational messages, tips to increase the intensity level of everyday activities, and strategies to reduce sedentary behaviors. Users can also track their physical activity levels and sedentary activity. Moving Up - A: Moving Up - A is a physical activity smartphone app for persons with mild cognitive impairment or mild forms of dementia. The app includes a personally tailored set of messages, tips, strategies, and tasks designed to increase physical activity levels and disrupt extended periods of sedentary time. Users also have the ability to track their steps and and sedentary behavior time as well as their progress towards activity goals. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Skin irritation from tape | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Participant reported skin irritation from the Tegederm tape used to adhere the activity monitor to the thigh. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Stacey Schepens Niemiec | University of Southern California | 3234422069 | schepens@usc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 28, 2021 | Apr 18, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D057185 | Sedentary Behavior |
| D003704 | Dementia |
| D008224 | Lymphoma, Follicular |
| D060825 | Cognitive Dysfunction |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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|
| App Usability Measured Using the User Version of the Mobile Application Rating Scale (uMARS) | The Mobile App Rating Scale User Version (uMARS) was used to measure user satisfaction with the app, particularly participant's ratings for app quality. The uMARS includes a usability feedback subindex which is comprised of the average of item responses for 4 subsections (engagement, functionality, aesthetics, information), to yield a total quality score. Ratings are on a scale of 1 (low perceived quality, min) to 5 (high perceived quality, max). | Month 2 |
| App Usage Behavior | Usage behavior is defined as the percentage of days the app was opened at least once across the 2-month trial period | from baseline through Month 2 (daily) |
| BG001 | 2-month Pilot Test - Study Partners | Target users (participants) were invited to have study partners to support use of the Moving Up-A app. |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Only target user (not study partner) data were collected and analyzed for this baseline measure. | Count of Participants | Participants |
|
| Race (NIH/OMB) | Only target user (not study partner) data were collected and analyzed for this baseline measure. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
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| Relationship to target user | This baseline measure is only relevant to study partners and not target users. | Count of Participants | Participants |
|
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|
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| Secondary | Daily Sitting Time (activPAL) Change From Baseline to Month 2 | Objective sedentary activity time was measured using the activPAL thigh-worn accelerometer during a 96-hour monitoring period. Expressed as average minutes/day. Change is computed as the activPAL-tracked mean minutes/day of sitting time at Month 2 minus that value at baseline. | Posted | Mean | Standard Deviation | sitting minutes/day | baseline and 2 months |
|
|
|
|
| Secondary | App Usability Measured Using the User Version of the Mobile Application Rating Scale (uMARS) | The Mobile App Rating Scale User Version (uMARS) was used to measure user satisfaction with the app, particularly participant's ratings for app quality. The uMARS includes a usability feedback subindex which is comprised of the average of item responses for 4 subsections (engagement, functionality, aesthetics, information), to yield a total quality score. Ratings are on a scale of 1 (low perceived quality, min) to 5 (high perceived quality, max). | Posted | Mean | Standard Deviation | score on a scale | Month 2 |
|
|
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| Secondary | App Usage Behavior | Usage behavior is defined as the percentage of days the app was opened at least once across the 2-month trial period | Posted | Mean | Standard Deviation | percentage of days | from baseline through Month 2 (daily) |
|
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| 1 |
| 15 |
| EG001 | Study Partners - Moving Up-A App | Target users (participants) were invited to have a study partner support them in using the Moving Up-A app. Study partners were not actively intervened on during this trial. | 0 | 6 | 0 | 6 | 0 | 6 |
|
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| D019965 |
| Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D003072 | Cognition Disorders |
| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
|
| Unknown or Not Reported |
|