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OpenTrials
Completed

NCT Number: NCT04950998

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

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

  2. 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).

  3. 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

Sponsors and collaborators

Lead sponsor

University of Southern California

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jul 6, 2021
Registry last updated
Jun 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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