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

June 2, 2023 updated by: Stacey L. Schepens Niemiec, University of Southern California

A Smartphone Application to Improve Physical Activity in Underactive Older Adults With Mild Cognitive Impairment/Mild Dementia

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90089-9003
        • University of Southern California

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

61 years and older (Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Target Users - Moving Up-A app
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.
Behavioral: 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.
Other: Study Partners - Moving Up-A app
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.
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Daily Steps Change From Baseline to Month 2
Time Frame: 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
baseline and 2 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Daily Sitting Time (activPAL) Change From Baseline to Month 2
Time Frame: 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.
baseline and 2 months
App Usability Measured Using the User Version of the Mobile Application Rating Scale (uMARS)
Time Frame: 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).
Month 2
App Usage Behavior
Time Frame: 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
from baseline through Month 2 (daily)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Southern California

Collaborators

National Institute on Aging (NIA)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 5, 2021

Primary Completion (Actual)

April 25, 2022

Study Completion (Actual)

April 25, 2022

Study Registration Dates

First Submitted

June 25, 2021

First Submitted That Met QC Criteria

June 25, 2021

First Posted (Actual)

July 6, 2021

Study Record Updates

Last Update Posted (Actual)

June 27, 2023

Last Update Submitted That Met QC Criteria

June 2, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HS-19-00444
  • 3R21AG052838-02S1 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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