search
Back to results

Smartphone App to Improve Physical Activity in Older Adults With MCI/Mild Dementia

Primary Purpose

Sedentary Lifestyle, Dementia, Mild, Mild Cognitive Impairment

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Moving Up - A
Sponsored by
University of Southern California
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Sedentary Lifestyle focused on measuring Smartphone app, Physical activity, Older adults

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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:

  • 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

Sites / Locations

  • University of Southern California

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Target Users - Moving Up-A app

Study Partners - Moving Up-A app

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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).
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

Full Information

First Posted
June 25, 2021
Last Updated
June 2, 2023
Sponsor
University of Southern California
Collaborators
National Institute on Aging (NIA)
search

1. Study Identification

Unique Protocol Identification Number
NCT04950998
Brief Title
Smartphone App to Improve Physical Activity in Older Adults With MCI/Mild Dementia
Official Title
A Smartphone Application to Improve Physical Activity in Underactive Older Adults With Mild Cognitive Impairment/Mild Dementia
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
December 5, 2021 (Actual)
Primary Completion Date
April 25, 2022 (Actual)
Study Completion Date
April 25, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Southern California
Collaborators
National Institute on Aging (NIA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sedentary Lifestyle, Dementia, Mild, Mild Cognitive Impairment, Memory and Thinking Problems
Keywords
Smartphone app, Physical activity, Older adults

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Target Users - Moving Up-A app
Arm Type
Other
Arm Description
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.
Arm Title
Study Partners - Moving Up-A app
Arm Type
Other
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Moving Up - A
Intervention Description
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.
Primary Outcome Measure Information:
Title
Daily Steps Change From Baseline to Month 2
Description
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
Secondary Outcome Measure Information:
Title
Daily Sitting Time (activPAL) Change From Baseline to Month 2
Description
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
Title
App Usability Measured Using the User Version of the Mobile Application Rating Scale (uMARS)
Description
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
Title
App Usage Behavior
Description
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
University of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90089-9003
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Smartphone App to Improve Physical Activity in Older Adults With MCI/Mild Dementia

We'll reach out to this number within 24 hrs