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

Mild Cognitive Impairment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04950998
• Other study ID #: HS-19-00444
• Secondary ID: 3R21AG052838-02S
• Status: Completed
• Phase: N/A
• Start date: December 5, 2021
• Est. completion date: April 25, 2022

Study information

• Verified date: June 2023
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: April 25, 2022
• Est. primary completion date: April 25, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Dementia
• Dementia, Mild
• Mild Cognitive Impairment
• Sedentary Lifestyle

Intervention

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.

Locations

Country	Name	City	State
United States	University of Southern California	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of Southern California	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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	baseline and 2 months
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.	baseline and 2 months
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).	Month 2
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	from baseline through Month 2 (daily)