N/A
Completed N=21
Smartphone App to Improve Physical Activity in Older Adults With MCI/Mild Dementia
Sedentary Lifestyle · Dementia, Mild · Mild Cognitive Impairment · Memory and Thinking Problems
Source: ClinicalTrials.gov NCT04950998 ↗
Enrolled (actual)
21
Serious AEs
0.0%
Results posted
Jun 2023
Primary outcomePrimary: Daily Steps Change From Baseline to Month 2 — 604.1 steps per day — p=0.376
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Daily Steps Change From Baseline to Month 2 |
604.1 | 0.376 |
| SECONDARY Daily Sitting Time (activPAL) Change From Baseline to Month 2 |
-35.0 | .444 |
| SECONDARY App Usability Measured Using the User Version of the Mobile Application Rating Scale (uMARS) |
3.997 | — |
| SECONDARY App Usage Behavior |
94.6 | — |
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
Data sourced from ClinicalTrials.gov (NCT04950998). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.