Dementia, Mild, Memory and Thinking Problems, Mild Cognitive Impairment, Sedentary Lifestyle
Conditions
Keywords
Smartphone app, Physical activity, Older adults
Brief summary
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.
Interventions
BEHAVIORALMoving 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.
Sponsors
National Institute on Aging (NIA)
University of Southern California
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
- Target User: * 65+ years old * English speaking; * resides in local Los Angeles area or the Pacific Time Zone; * self-reported memory or thinking problems that score within a range of mildly impaired on a cognitive test or a clinical diagnosis of cognitive impairment ranging from mild cognitive impairment (MCI) or mild dementia (of any form). Mild dementia is the top end of this clinical diagnosis range. MCI is the low end of the range. * reports \<150 minutes of moderate to vigorous physical activity per week as per a single-item screener; * self-reported ability to safely engage in regular walking; * smartphone owner of a compatible smartphone for ≥1 month; * willing and available second family member/friend/caregiver who owns a smartphone and can attend training sessions; and * observed ability to reliably access and operate a smartphone during training.
Exclusion criteria
- Target User: * unwillingness to meet at local community venues and/or via online meetings * unwillingness to comply with study procedures for the length of the study * inability to participate in English. * residing outside of the local Los Angeles (LA) area and do not have the capacity to participate remotely or commuting to the University of Southern California (USC) study site * recent cognitive status does not fall within an acceptable MCI/mild dementia range as determined through Montreal Cognitive Assessment (MoCA) if diagnosis was unverified by health care provider or by ADRC or memory and thinking problems were self-reported * recent cognitive status is below what is acceptable for MCI/mild dementia as determined through MoCA if diagnosis was verified by health care provider or ADRC Inclusion Criteria - Study Partner: * English-speaking * Family member/friend/caregiver of target user * Owns a smartphone * Willing to attend training sessions Note: age limit criterion for target users does not apply to study partners
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Daily Steps Change From Baseline to Month 2 | baseline and 2 months | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Daily Sitting Time (activPAL) Change From Baseline to Month 2 | baseline and 2 months | 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. |
| App Usability Measured Using the User Version of the Mobile Application Rating Scale (uMARS) | Month 2 | 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). |
| App Usage Behavior | from baseline through Month 2 (daily) | Usage behavior is defined as the percentage of days the app was opened at least once across the 2-month trial period |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 15 |
| 2-month Pilot Test - Study Partners Target users (participants) were invited to have study partners to support use of the Moving Up-A app. | 6 |
| Total | 21 |
Baseline characteristics
| Characteristic | Total | 2-month Pilot Test - Target Users | 2-month Pilot Test - Study Partners |
|---|---|---|---|
| Age, Continuous | 73.1 years STANDARD_DEVIATION 4.7 | 73.1 years STANDARD_DEVIATION 4.7 | — |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | — |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 15 Participants | 15 Participants | — |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | — |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | — |
| Race (NIH/OMB) Asian | 3 Participants | 3 Participants | — |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | — |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | — |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 1 Participants | — |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | — |
| Race (NIH/OMB) White | 11 Participants | 11 Participants | — |
| Region of Enrollment United States | 21 Participants | 15 Participants | 6 Participants |
| Relationship to target user Adult child | 1 Participants | — | 1 Participants |
| Relationship to target user Spouse/partner | 5 Participants | — | 5 Participants |
| Sex: Female, Male Female | 13 Participants | 9 Participants | 4 Participants |
| Sex: Female, Male Male | 8 Participants | 6 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 6 |
| other Total, other adverse events | 1 / 15 | 0 / 6 |
| serious Total, serious adverse events | 0 / 15 | 0 / 6 |
Outcome results
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
Time frame: baseline and 2 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Target Users - Moving Up-A App | Daily Steps Change From Baseline to Month 2 | 604.1 steps per day | Standard Deviation 2560.4 |
p-value: 0.37695% CI: [-813.815, 2021.95]t-test, 2 sided
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).
Time frame: Month 2
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Target Users - Moving Up-A App | App Usability Measured Using the User Version of the Mobile Application Rating Scale (uMARS) | 3.997 score on a scale | Standard Deviation 0.541 |
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
Time frame: from baseline through Month 2 (daily)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Target Users - Moving Up-A App | App Usage Behavior | 94.6 percentage of days | Standard Deviation 10.4 |
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.
Time frame: baseline and 2 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Target Users - Moving Up-A App | Daily Sitting Time (activPAL) Change From Baseline to Month 2 | -35.0 sitting minutes/day | Standard Deviation 172.2 |
p-value: 0.44495% CI: [-130.36, 60.324]t-test, 2 sided