MHealth System for Chronic Health Conditions

Overseen By Zara Ambadar, Ph.D.

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University of Pittsburgh

Disqualifiers: Severe intellectual disability, psychiatric illness, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

Duration: 12 months

160 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a mobile health system (MHealth) can help individuals with long-term conditions, such as Spinal Cord Injury or Cerebral Palsy, manage their health more effectively than usual care alone. Participants will either use this mobile system alongside their regular care or continue with just their regular care to compare outcomes. It suits those with a chronic condition who live at home (not in a care facility) and can use a smartphone. As an unphased trial, this study provides a unique opportunity to explore innovative health management solutions.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications, so it's best to ask the trial coordinators for more details.

What prior data suggests that this mobile health system is safe for individuals with chronic health conditions?

Research has shown that mobile health (mHealth) systems are generally safe for managing long-term health conditions. Many studies have explored how these systems assist in tracking health, providing feedback, educating users, and encouraging healthier habits. Surveys and interviews often collect information, indicating that users generally have a positive experience with the technology.

While specific negative effects are rarely reported, user feedback suggests that any issues relate more to the system's ease of use and setup rather than safety concerns. Since this study is not tied to a specific phase, the main goal is to assess the system's effectiveness rather than to prove its safety, which is usually the focus of early trials. Overall, using mHealth for managing chronic conditions has been positive, indicating it is generally safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the MHealth system for chronic health conditions because it leverages cutting-edge mobile technology to enhance patient engagement and monitoring. Unlike standard treatments that rely heavily on in-person visits and routine medication, this system provides real-time health tracking and feedback, offering personalized insights and support directly through a smartphone or tablet. This approach not only aims to improve adherence to treatment plans but also empowers patients by giving them more control over managing their health. By integrating seamlessly with everyday life, the MHealth system has the potential to revolutionize chronic care management, making it more efficient and patient-centered.

What evidence suggests that this mHealth system is effective for improving wellness and self-management in individuals with chronic health conditions?

This trial will compare a mobile health (mHealth) system with standard care for managing chronic health conditions. Studies have shown that mHealth systems can aid in managing long-term health conditions. Research suggests these digital tools can enhance quality of life by supporting physical, mental, and social well-being. For instance, combining mHealth with professional care has proven beneficial for managing conditions like diabetes and increasing daily activity. Many studies emphasize mHealth's role in better monitoring and providing feedback, which can guide lifestyle and health decisions. Although not all studies find mHealth superior to traditional care, the technology shows promise in improving chronic disease management. ^{3 6 7 8 9}

Who Is on the Research Team?

Brad E. Dicianno, M.D.

Principal Investigator

University of Pittsburgh

Bambang Parmanto, Ph.D.

Principal Investigator

University of Pittsburgh

Andi Saptono, Ph.D.

Principal Investigator

University of Pittsburgh

Are You a Good Fit for This Trial?

This trial is for individuals aged 12 or older with chronic conditions like Spinal Cord Injury, Cerebral Palsy, Spina Bifida, or Traumatic Brain Injury. They must be able to use a smartphone and live outside of care facilities. Those with severe intellectual disabilities or persistent psychiatric illnesses cannot participate.

Inclusion Criteria

I have a chronic condition like Spina Bifida or Cerebral Palsy.

Live in a community setting (not within a residential facility that provides care to them)

Pass all the functional screening tests which include basic usage of a smart phone, and impairment severity assessments

Exclusion Criteria

Diagnosis of severe intellectual disability or severe and persistent psychiatric illness

Failing all the screening tests due to severe impairments that cannot be accommodated by the mHealth system (for patient participants)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Initial assessment of psychosocial and medical outcomes using various questionnaires

1 week

1 visit (in-person)

Treatment

Participants in the mHealth group use the mobile health system alongside standard care, while the control group continues with standard care only

12 months

Quarterly assessments (every 3 months)

Follow-up

Participants are monitored for changes in psychosocial outcomes and medical conditions

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• MHealth

Trial Overview The study tests a mobile health (mHealth) system designed to help people with complex health conditions manage their wellness better compared to standard care. It aims to improve self-management skills through the use of technology.

How Is the Trial Designed?

Group I: MHealth Group Experimental Treatment 1 Intervention

Participants randomized into this group will use the mHealth system throughout the study in conjunction with their standard of care

Group II: Control Active Control 1 Intervention

Participants randomized into this group will not use the mHealth system throughout the study, but will continue with their standard of care.

Who Is Running the Clinical Trial?

University of Pittsburgh

Lead Sponsor

Trials

1,820

Recruited

16,360,000+

Department of Health and Human Services

Collaborator

Trials

240

Recruited

944,000+

Published Research Related to This Trial

A systematic review of 32 studies on mobile health (mHealth) interventions for chronic illness self-care revealed that those with positive clinical outcomes often utilized more digital input, suggesting that technology features play a crucial role in effectiveness.

Most studies lacked detailed descriptions of the software used, and only two involved the target audience in the development process, highlighting the need for better system descriptions and user involvement in future mHealth research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An integrative review of chronic illness mHealth self-care interventions: Mapping technology features to patient outcomes. Sockolow, PS., Buck, HG., Shadmi, E.[2021]

mHealth systems can automatically collect and analyze glucose data, providing real-time decision support for both patients and healthcare professionals, which can lead to timely and personalized treatment decisions.

While mHealth shows promise for diabetes management, rigorous testing and regulatory approval are necessary to ensure safety, effectiveness, and to address privacy, clinical, and economic concerns for widespread adoption.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The current status of mHealth for diabetes: will it be the next big thing? Klonoff, DC.[2022]

Biomarkers play a crucial role in diagnosing and managing chronic diseases, which are significant health and economic challenges globally.

The integration of mobile health (mHealth) technologies with biomarkers is set to revolutionize chronic disease management, providing caregivers with more efficient and interactive tools for patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Laboratory medicine and mobile health technologies at crossroads: Perspectives for the management of chronic diseases. Gruson, D., Ko, G.[2018]

The development of a remote monitoring system for individuals with chronic diseases involves multiple stages, focusing on assessing health status and predicting disease exacerbations.

Effective monitoring and control of chronic diseases can be achieved through systematic approaches that utilize technology to track ongoing health conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Remote System for Monitoring the State of Health of People with Chronic Diseases and Predicting Periods of Exacerbation. Yuldashev, ZM.[2023]

A survey of 480 patients and 31 general practitioners (GPs) revealed that while 56% of patients and 42% of GPs were willing to use mobile health (mHealth) applications for reporting adverse drug reactions (ADRs), willingness decreased with age for both groups.

Patients valued rapid feedback on consultation urgency, while GPs preferred information on medication administration difficulties; however, barriers included older patients' preference for personal contact with their GP and GPs' concerns about time and resource demands.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing a Mobile Health Application to Communicate Adverse Drug Reactions - Preconditions, Assessment of Possible Functionalities and Barriers for Patients and Their General Practitioners. Wakob, I., Schmid, GL., Nöhring, I., et al.[2022]

The Brain Buddy mobile health technology was found to have good usability, with a mean score of 78.8 on the System Usability Scale, indicating that all 23 older adult participants could complete tasks effectively.

After using Brain Buddy, 100% of participants felt more informed about their anticholinergic medications, and 82% reported discussing their medication risks with their physician, demonstrating the tool's potential to enhance medication safety and patient engagement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Usability and feasibility of consumer-facing technology to reduce unsafe medication use by older adults. Holden, RJ., Campbell, NL., Abebe, E., et al.[2020]

A study involving 129 patients using a mobile health app for hypertension management developed a model that explains factors influencing continuous use of mobile health services, highlighting the importance of perceived usefulness, user satisfaction, and perceived health status.

The model showed that service quality, information quality, and system quality positively influenced perceived usefulness, which in turn significantly affected user satisfaction and the intention to continue using the app for self-management of chronic conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Measuring Success of Patients' Continuous Use of Mobile Health Services for Self-management of Chronic Conditions: Model Development and Validation. Song, T., Deng, N., Cui, T., et al.[2021]

Out of 45 chronic disease management apps evaluated in China, 73% had a privacy policy, but the overall compliance with the Personal Information Security Specification was low, averaging only 40.4 out of 100.

The weakest area of compliance was in information storage and protection, with an average score of just 29.4%, highlighting significant privacy risks for users' health data.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Privacy Policy Compliance of Chronic Disease Management Apps in China: Scale Development and Content Evaluation. Ni, Z., Wang, Y., Qian, Y.[2021]

The development of a community-based self-management system for diabetes incorporates SMS, web-based, and mobile functionalities, aiming to improve diabetes management and reduce health complications.

This system addresses the significant public health burden caused by poor diabetes self-management, highlighting the growing importance of telehealth solutions in global health systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Design of a large scale community-based self-management system for diabetes mellitus. Chan, KC., Wong, L., Chan, DB.[2017]

Mobile health (mHealth) apps are categorized by their functions, such as behavior change and self-management, but there is limited clinical guidance on their effective use in patient care, highlighting a gap in evidence-based recommendations.

Data security and patient privacy are major concerns when using mHealth apps, and there is a need for better involvement of patients in the development of guidelines to ensure that these apps meet their needs and improve clinical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What is the clinical value of mHealth for patients? Rowland, SP., Fitzgerald, JE., Holme, T., et al.[2023]

Mobile health (mHealth) applications can enhance communication and collaboration between patients and providers, potentially improving the management of chronic diseases.

The review critically evaluates three theoretical frameworks that can guide the research and practice of mHealth in facilitating better patient-provider interactions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Utilization of Mobile Applications in Collaborative Patient-Provider Monitoring of Chronic Health Conditions: An Examination of Three Theoretical Frameworks to Guide Practice. Donevant, SB., Messias, DKH., Estrada, RD.[2020]

A new Chronic Disease mHealth App Intervention Design Framework was developed to guide the creation of mobile health applications, integrating clinical and behavioral evidence to improve chronic disease management.

This framework supports the systematic development and evaluation of mHealth solutions, making it easier to create effective apps tailored to different diseases and populations, ultimately enhancing patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evidence-Based mHealth Chronic Disease Mobile App Intervention Design: Development of a Framework. Wilhide Iii, CC., Peeples, MM., Anthony Kouyaté, RC.[2022]

Improving self-management skills is crucial for individuals with chronic conditions like diabetes, and having high self-efficacy plays a significant role in this process.

The digital health intervention 'Better Choices, Better Health' effectively enhances self-efficacy and supports self-management in adults with chronic conditions, demonstrating a scalable and affordable approach to improving health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Digital Therapeutics: Leading the Way to Improved Outcomes for People With Diabetes. Kaufman, N.[2020]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39589770/

Usability and Effectiveness of eHealth and mHealth ... This systematic review aimed to evaluate the features, acceptability, usability, engagement, and intervention efficacy of eHealth and mHealth interventions

2. sciencedirect.com sciencedirect.com/science/article/pii/S1386505625000371

Effectiveness of digital health interventions for chronic ... Digital health interventions have not yet demonstrated substantial benefits over traditional care for chronic disease management in European primary care.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10176143/

Evaluation of the Effectiveness of Telehealth Chronic ... TCDMS positively affected patients' physical, mental, and social quality of life across multiple chronic diseases.

4. i-jmr.org i-jmr.org/2025/1/e55835

The Effect of Combining mHealth and Health Professional– ... This study confirmed short- and medium-term benefits of mHealth combined with professional interventions for HbA 1c , QoL, and short-term physical activity.

5. sciencedirect.com sciencedirect.com/science/article/pii/S2667102621000346

Mobile health technology: a novel tool in chronic disease ... Many studies have evaluated the utility of mHealth as a tool to improve chronic disease management through monitoring and feedback, educational and lifestyle ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11671791/

Current Implementation of Digital Health in Chronic ... The main method used to assess outcomes was surveys (173/252, 68.7%), followed by interviews (95/252, 37.7%). Key barriers impacting implementation were data ...

7. jmir.org jmir.org/2024/1/e53576/

Current Implementation of Digital Health in Chronic ... The main method used to assess outcomes was surveys (173/252, 68.7%), followed by interviews (95/252, 37.7%). Key barriers impacting ...

8. bmchealthservres.biomedcentral.com bmchealthservres.biomedcentral.com/articles/10.1186/s12913-024-11505-y

Mobile solution and chronic diseases: development and ... Mobile solution and chronic diseases: development and implementation of a mobile application and digital platform for collecting, analyzing data ...

9. who.int who.int/health-topics/digital-health

Digital health The purpose for a Global Strategy on Digital Health is to promote healthy lives and wellbeing for everyone, everywhere, at all ages.