Clinical trial NCT04950998: 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
Overall status: COMPLETED
Phase: NA
Conditions: Sedentary Lifestyle
Dementia, Mild
Mild Cognitive Impairment
Memory and Thinking Problems
Keywords: Smartphone app
Physical activity
Older adults
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2021-07-06
Enrollment: 21
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


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

Primary outcomes:
measure: Daily Steps Change From Baseline to Month 2
timeFrame: baseline and 2 months
Secondary outcomes:
measure: Daily Sitting Time (activPAL) Change From Baseline to Month 2
timeFrame: baseline and 2 months
measure: App Usability Measured Using the User Version of the Mobile Application Rating Scale (uMARS)
timeFrame: Month 2
measure: App Usage Behavior
timeFrame: from baseline through Month 2 (daily)
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of Southern California
state: California
Study officials:
References: