Trial Outcomes & Findings for Smartphone App to Improve Physical Activity in Older Adults With MCI/Mild Dementia (NCT NCT04950998)

Last Updated: 2023-06-27

Results Overview

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

Recruitment status

COMPLETED

Study phase

Target enrollment

21 participants

Primary outcome timeframe

baseline and 2 months

Results posted on

2023-06-27

Participant Flow

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.

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	15	6
Overall Study COMPLETED	15	6
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Only target user (not study partner) data were collected and analyzed for this baseline measure.

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: baseline and 2 months

Outcome measures

Outcome measures
Measure	Target Users - Moving Up-A App n=15 Participants 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.
Daily Steps Change From Baseline to Month 2	604.1 steps per day Standard Deviation 2560.4

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Target Users - Moving Up-A App n=15 Participants 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.
Daily Sitting Time (activPAL) Change From Baseline to Month 2	-35.0 sitting minutes/day Standard Deviation 172.2

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Target Users - Moving Up-A App n=15 Participants 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.
App Usability Measured Using the User Version of the Mobile Application Rating Scale (uMARS)	3.997 score on a scale Standard Deviation .541

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Target Users - Moving Up-A App n=15 Participants 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.
App Usage Behavior	94.6 percentage of days Standard Deviation 10.4

Adverse Events

Target Users - Moving Up-A App

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Study Partners - Moving Up-A App

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Target Users - Moving Up-A App n=15 participants at risk 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.	Study Partners - Moving Up-A App n=6 participants at risk 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.
Skin and subcutaneous tissue disorders Skin irritation from tape	6.7% 1/15 • Number of events 1 • 2 months	0.00% 0/6 • 2 months

Additional Information

Dr. Stacey Schepens Niemiec

University of Southern California

Phone: 3234422069

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	2-month Pilot Test - Target Users n=15 Participants 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.	2-month Pilot Test - Study Partners n=6 Participants Target users (participants) were invited to have study partners to support use of the Moving Up-A app.	Total n=21 Participants Total of all reporting groups
Age, Continuous	73.1 years STANDARD_DEVIATION 4.7 • n=15 Participants • Only target user (not study partner) data were collected and analyzed for this baseline measure.	—	73.1 years STANDARD_DEVIATION 4.7 • n=15 Participants • Only target user (not study partner) data were collected and analyzed for this baseline measure.
Sex: Female, Male Female	9 Participants n=15 Participants	4 Participants n=6 Participants	13 Participants n=21 Participants
Sex: Female, Male Male	6 Participants n=15 Participants	2 Participants n=6 Participants	8 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=15 Participants • Only target user (not study partner) data were collected and analyzed for this baseline measure.	—	0 Participants n=15 Participants • Only target user (not study partner) data were collected and analyzed for this baseline measure.
Ethnicity (NIH/OMB) Not Hispanic or Latino	15 Participants n=15 Participants • Only target user (not study partner) data were collected and analyzed for this baseline measure.	—	15 Participants n=15 Participants • Only target user (not study partner) data were collected and analyzed for this baseline measure.
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=15 Participants • Only target user (not study partner) data were collected and analyzed for this baseline measure.	—	0 Participants n=15 Participants • Only target user (not study partner) data were collected and analyzed for this baseline measure.
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=15 Participants • Only target user (not study partner) data were collected and analyzed for this baseline measure.	—	0 Participants n=15 Participants • Only target user (not study partner) data were collected and analyzed for this baseline measure.
Race (NIH/OMB) Asian	3 Participants n=15 Participants • Only target user (not study partner) data were collected and analyzed for this baseline measure.	—	3 Participants n=15 Participants • Only target user (not study partner) data were collected and analyzed for this baseline measure.
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=15 Participants • Only target user (not study partner) data were collected and analyzed for this baseline measure.	—	1 Participants n=15 Participants • Only target user (not study partner) data were collected and analyzed for this baseline measure.
Race (NIH/OMB) Black or African American	0 Participants n=15 Participants • Only target user (not study partner) data were collected and analyzed for this baseline measure.	—	0 Participants n=15 Participants • Only target user (not study partner) data were collected and analyzed for this baseline measure.
Race (NIH/OMB) White	11 Participants n=15 Participants • Only target user (not study partner) data were collected and analyzed for this baseline measure.	—	11 Participants n=15 Participants • Only target user (not study partner) data were collected and analyzed for this baseline measure.
Race (NIH/OMB) More than one race	0 Participants n=15 Participants • Only target user (not study partner) data were collected and analyzed for this baseline measure.	—	0 Participants n=15 Participants • Only target user (not study partner) data were collected and analyzed for this baseline measure.
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=15 Participants • Only target user (not study partner) data were collected and analyzed for this baseline measure.	—	0 Participants n=15 Participants • Only target user (not study partner) data were collected and analyzed for this baseline measure.
Region of Enrollment United States	15 Participants n=15 Participants	6 Participants n=6 Participants	21 Participants n=21 Participants
Relationship to target user Adult child	—	1 Participants n=6 Participants • This baseline measure is only relevant to study partners and not target users.	1 Participants n=6 Participants • This baseline measure is only relevant to study partners and not target users.
Relationship to target user Spouse/partner	—	5 Participants n=6 Participants • This baseline measure is only relevant to study partners and not target users.	5 Participants n=6 Participants • This baseline measure is only relevant to study partners and not target users.