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

NCT04950998 | Completed Results

• 2 other identifiers: HS-19-004443R21AG052838-02S1
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Sedentary Lifestyle; Dementia, Mild; Mild Cognitive Impairment; Memory and Thinking Problems

Keywords

Smartphone app; Physical activity; Older adults

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Daily Sitting Time (activPAL) Change From Baseline to Month 2

  baseline and 2 months

• App Usability Measured Using the User Version of the Mobile Application Rating Scale (uMARS)

  Month 2

• App Usage Behavior

  from baseline through Month 2 (daily)

Study Arms (2)

Target Users - Moving Up-A app

OTHER

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

Study Partners - Moving Up-A app

OTHER

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

Interventions

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.

Study Partners - Moving Up-A app; Target Users - Moving Up-A app

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• + 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University of Southern California: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

University of Southern California

Los Angeles, California, 90089-9003, United States

Location

MeSH Terms

Conditions

Sedentary Behavior; Dementia; Lymphoma, Follicular; Cognitive Dysfunction; Motor Activity

Condition Hierarchy (Ancestors)

Behavior; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Cognition Disorders

Results Point of Contact

• Title: Dr. Stacey Schepens Niemiec
• Organization: University of Southern California

schepens@usc.edu

3234422069

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Research

Study Record Dates

• First Submitted: June 25, 2021
• First Posted: July 6, 2021
• Study Start: December 5, 2021
• Primary Completion: April 25, 2022
• Study Completion: April 25, 2022
• Last Updated: June 27, 2023
• Results First Posted: June 27, 2023

Record last verified: 2023-06

Locations

US (1)