mPATH for Cognitive Impairment and Insomnia

Overseen By Julianna Kruemmel

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Disqualifiers: Sleep apnea, Severe depression, Dementia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

176 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a special physical activity program, called mPATH (Mobile Patient Technology for Health), can improve thinking skills and sleep quality in older adults with low income. mPATH includes personalized exercise plans, home workout videos, and regular phone check-ins over several months. Older adults who have trouble sleeping, don't exercise much, and have a low household income might be a good fit for this trial. However, those with untreated sleep apnea or certain mental health conditions may not be suitable candidates. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance the quality of life for older adults.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the mPATH intervention is safe for low-income older adults?

Research shows that the mPATH program offers a personalized exercise plan, including workout routines, training sessions, home exercise videos, and regular phone coaching. The program uses wearable devices and mobile health (mHealth) tools to support participants.

Exercise programs like mPATH are generally well-received and aim to improve overall health and fitness. Research has not reported any negative effects linked to mPATH. The study's "Not Applicable" label for typical trial phases suggests that mPATH is likely safe for general use.

Participants usually find these activities safe, especially with personalized plans and professional guidance. However, discussing any concerns with a healthcare provider before joining a trial is always best. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about mPATH for cognitive impairment and insomnia because it offers a personalized approach to physical activity, which is different from standard treatments like medication or cognitive behavioral therapy. mPATH provides customized exercise plans and training sessions, supported by wearable devices and mHealth strategies, to boost physical activity at home. This innovative use of technology and personalization could lead to improved outcomes by directly engaging participants in their own care and potentially offering a more sustainable lifestyle change.

What evidence suggests that the mPATH intervention is effective for cognitive impairment and insomnia?

Research shows that exercise can help older adults think more clearly and sleep better. In this trial, the mPATH program, which participants may receive, offers personalized exercise plans and uses wearable devices to enhance these benefits. Studies have found that mobile health tools like mPATH encourage healthier habits, improving brain function. Although specific data on mPATH's effectiveness for low-income older adults is limited, similar programs have shown good results. Therefore, mPATH could likely help improve thinking and sleep in this group. ^{1 2 3 4 6}

Who Is on the Research Team?

Junxin Li

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

This trial is for low-income older adults who have trouble sleeping, lead a sedentary lifestyle without much exercise, and can do moderate intensity workouts. It's not suitable for those who don't meet the income criteria or cannot safely engage in physical activity.

Inclusion Criteria

Lack of physical activity/exercise

Low household income

Self-reported difficulty of sleep

Exclusion Criteria

Current enrollment in another clinical trial

I have a history of brain injury or mental health disorders.

I have sleep apnea that has not been treated.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the mPATH intervention, which includes personalized physical activity plans, training sessions, exercise at home with videos, and biweekly phone coaching over 24 weeks

24 weeks

Biweekly phone coaching

Follow-up

Participants are monitored for changes in cognitive function and sleep efficiency

6 months

Monthly home visits

Extension

mHealth strategies and exercise videos continue to support participant's physical activity

6-12 months

What Are the Treatments Tested in This Trial?

Interventions

• mPATH

Trial Overview The study tests an mHealth-facilitated program called mPATH designed to improve sleep and cognitive function through increased physical activity. Participants will either receive this intervention or be part of an attention control group for comparison.

How Is the Trial Designed?

Group I: mPATH Experimental Treatment 1 Intervention

mPATH is a personalized physical activity intervention that includes personalized physical activity plans and training sessions, exercise at home by following personalized exercise videos, and biweekly phone coaching over 24 weeks, supported by wearable devices-enabled mHealth strategies. mHealth strategies and exercise videos will be used to support participant's physical activity during 6-12months

Group II: Education and Social control Active Control 1 Intervention

This attention control group is designed to match the intervention for mPATH's staff-subject interaction duration through monthly home visits in the first 6 months

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Published Research Related to This Trial

The iREST app, designed for delivering cognitive behavioral therapy for insomnia (CBTI), was found to be highly usable among 19 Active Duty Service Members and Veterans, achieving an excellent usability score of 85.74, indicating it is an effective tool for improving access to insomnia treatment.

The app's design allows for real-time monitoring and personalized interventions, making it a promising solution for overcoming barriers to traditional CBTI delivery in specialty clinics, while also integrating wearable technology to enhance sleep pattern assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a Just-in-Time Adaptive mHealth Intervention for Insomnia: Usability Study. Pulantara, IW., Parmanto, B., Germain, A.[2023]

The review analyzed 54 studies on mobile health (mHealth) programs promoting physical activity, identifying 31 methods to measure user adherence, which were categorized into 8 indicators across 4 dimensions.

Adherence to mHealth programs is significantly linked to positive health outcomes, and a new framework was developed to help understand and measure adherence, which could guide future research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Measurement of Adherence to mHealth Physical Activity Interventions and Exploration of the Factors That Affect the Adherence: Scoping Review and Proposed Framework. Yang, Y., Boulton, E., Todd, C.[2022]

A study involving 55 participants over 6 months found that individual factors like self-monitoring and goal setting, along with social factors such as user interaction, significantly influenced engagement with a mobile app designed to promote physical activity.

Technological features like automation and personalization enhanced user experience, but limitations in technology were identified as barriers to long-term use, suggesting that interventions need to be tailored to meet diverse user preferences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using a Mobile Social Networking App to Promote Physical Activity: A Qualitative Study of Users' Perspectives. Tong, HL., Coiera, E., Laranjo, L.[2020]

This systematic review identified only 15 studies evaluating 8 different mHealth apps for sleep disturbances, highlighting a significant gap between the number of available commercial apps and those with evidence-based design and clinical evaluation.

Most apps focused on delivering cognitive behavioral therapy for insomnia (CBT-I), but only one app had a robust randomized controlled trial supporting its efficacy, indicating a need for more rigorous testing and standardization in app development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Framework for the Design Engineering and Clinical Implementation and Evaluation of mHealth Apps for Sleep Disturbance: Systematic Review. Aji, M., Gordon, C., Stratton, E., et al.[2021]

The newly developed mHealth application (PAC app) shows promise for enhancing personalized physical activity counseling in primary health care settings, as indicated by focus group discussions with 16 health care providers.

However, successful implementation of the PAC app faces challenges, including barriers to use by providers and the need for patient involvement, highlighting the importance of understanding the service delivery context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Challenges of Implementing an mHealth Application for Personalized Physical Activity Counselling in Primary Health Care: A Qualitative Study. Wattanapisit, A., Amaek, W., Wattanapisit, S., et al.[2022]

The 'Moving Up' app, designed to increase physical activity among underactive older adults, showed good usability and acceptability after beta-testing with 13 participants aged around 71 years.

Feedback from older adults highlighted the importance of personalized messaging and timely notifications, suggesting that involving them in the design process can lead to more effective health interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preliminary User Evaluation of a Physical Activity Smartphone App for Older Adults. Schepens Niemiec, SL., Wagas, R., Vigen, CLP., et al.[2023]

The study aims to evaluate the effectiveness of a mobile app called Stay Strong, which tracks physical activity and weight in veterans, comparing the impact of the app alone versus the app combined with personalized health coaching over a year.

With 357 veterans enrolled, the trial will assess whether adding coaching features, such as tailored messaging and phone calls, enhances physical activity levels compared to using the app without coaching.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Understanding the Effect of Adding Automated and Human Coaching to a Mobile Health Physical Activity App for Afghanistan and Iraq Veterans: Protocol for a Randomized Controlled Trial of the Stay Strong Intervention. Buis, LR., McCant, FA., Gierisch, JM., et al.[2020]

A 24-week mHealth intervention for 21 older adults led to increased physical activity levels compared to a control group, with improvements observed at 8, 16, and 24 weeks, although activity levels decreased slightly by 24 weeks compared to earlier assessments.

The intervention also significantly improved subjective sleep quality and increased both sleep duration and efficiency by the end of the study, suggesting that mHealth strategies can positively impact both physical activity and sleep in older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An mHealth-Facilitated Personalized Intervention for Physical Activity and Sleep in Community-Dwelling Older Adults. Li, J., Szanton, SL., McPhillips, MV., et al.[2023]

A study involving 176 participants (9 in focus groups and 167 in an online survey) identified that users with poor sleep prefer personalized features in a sleep app, such as sleep diaries and alarms, to enhance engagement and effectiveness.

Most participants (93%) expressed willingness to try an evidence-based sleep app, highlighting the importance of tailoring app functionalities to user needs, especially for those with severe insomnia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploring User Needs and Preferences for Mobile Apps for Sleep Disturbance: Mixed Methods Study. Aji, M., Gordon, C., Peters, D., et al.[2020]

Citations

1. reporter.nih.gov reporter.nih.gov/project-details/10913610

Project Details This randomized controlled trial is designed to examine the immediate and sustaining efficacy of an mHealth-facilitated Physical Activity Toward Health (mPATH) ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05935241

NCT05935241 | mPATH for Low-income Older Adults The study aims to test the immediate and sustaining efficacy of an mHealth-facilitated Physical Activity Toward Health (mPATH) intervention on cognitive ...

3. nursing.jhu.edu nursing.jhu.edu/faculty-research/research/projects/mhealth-facilitated-physical-activity-toward-health-mpath/

mHealth-Facilitated Physical Activity Toward Health (mPATH) The study aims to test the immediate and sustaining efficacy of an mHealth-facilitated Physical Activity Toward Health (mPATH) intervention on cognitive ...

4. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05935241/mpath-for-low-income-older-adults

mPATH for Low-income Older Adults | Clinical Research ... The study aims to test the immediate and sustaining efficacy of an mHealth-facilitated Physical Activity Toward Health (mPATH) intervention on ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0197457224004683

Health-promoting lifestyle mediates the relationship ... A health-promoting lifestyle can fully mediate the association between mobile health technology acceptance and cognitive function.

6. researchprotocols.org researchprotocols.org/2025/1/e74174

Promoting Physical Activity and Preventing Falls Among ... Methods: We iteratively developed a novel, tablet-based mobile app (BeSt Age) that enables nursing home staff to deliver individualized physical ...