Sedentary LifestyleNCT04950998
Smartphone App to Improve Physical Activity in Older Adults With MCI/Mild Dementia
A study testing Moving Up - A in people with Sedentary Lifestyle and Dementia, Mild, run by University of Southern California at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Sedentary Lifestyle, Dementia, Mild, Mild Cognitive Impairment
- What is being tested?
- Moving Up - A
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Dec 2021to 25 Apr 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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;
Show all 14Show fewer
- 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.
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Southern California
Los Angeles, California, 90089-9003
About this study
Official title: A Smartphone Application to Improve Physical Activity in Underactive Older Adults With Mild Cognitive Impairment/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.
- Conditions
- Sedentary Lifestyle, Dementia, Mild, Mild Cognitive Impairment, Memory and Thinking Problems
- Being tested
- Moving Up - A
- Keywords
- Smartphone app, Physical activity, Older adults
- Medical subject headings
- Sedentary Behavior, Dementia, Lymphoma, Follicular, Cognitive Dysfunction, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moving Up - ABehavioural
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Moving Up - A |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: baseline and 2 months
Secondary outcomes (3)
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.
Measured: baseline and 2 months
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).
Measured: Month 2
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
Measured: from baseline through Month 2 (daily)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2021
- Study start5 Dec 2021
- Primary completion25 Apr 2022
- Study completion25 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Sedentary LifestyleStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Stacey L. Schepens Niemiec, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04950998
- Sponsor's protocol ID
- HS-19-00444
- Other IDs
- 3R21AG052838-02S1
- Status last verified
- Jun 2023
- First submitted
- 25 Jun 2021
- Last updated
- 27 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Smartphone Application to Improve Physical Activity in Underactive Older Adults With Mild Cognitive Impairment/Mild Dementia
- ClinicalTrials.gov ID
- NCT04950998
- Acronym / sponsor ID
- HS-19-00444
- Conditions
- Sedentary Lifestyle, Dementia, Mild, Mild Cognitive Impairment, Memory and Thinking Problems
- Keywords
- Smartphone app, Physical activity, Older adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 5 Dec 2021 (actual)
- Primary completion
- 25 Apr 2022 (actual)
- Study completion
- 25 Apr 2022 (actual)
- First posted
- 6 Jul 2021 (actual)
- Results
- Posted 27 Jun 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Target Users - Moving Up-A app | Other | Behavioral: Moving Up - AIn 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. |
| Study Partners - Moving Up-A app | Other | Behavioral: Moving Up - AIn 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (14 listed)
- 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;
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Moving Up - AMoving 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. | Behavioural | Study Partners - Moving Up-A app, Target Users - Moving Up-A app |
Primary outcome
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
3 secondary outcomes
Daily Sitting Time (activPAL) Change From Baseline to Month 2
Time frame: baseline and 2 months
App Usability Measured Using the User Version of the Mobile Application Rating Scale (uMARS)
Time frame: Month 2
App Usage Behavior
Time frame: from baseline through Month 2 (daily)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Moving Up - A in people with Sedentary Lifestyle and Dementia, Mild, run by University of Southern California at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Jun 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Daily Steps Change From Baseline to Month 2 (time frame: baseline and 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2023.