Mobile Health Platform for Cystic Fibrosis

(NUDGE Trial)

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Nemours Children's Clinic

Disqualifiers: Neurological condition, Cognitive impairment, Oxygen requirement

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

Compensation: Varies

Number of Visits: 4

Duration: 6 months

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a smartphone program called NUDGE, designed to help teens and young adults with Cystic Fibrosis (CF) increase their physical activity. NUDGE acts as a digital coach, assisting users in setting and tracking goals, monitoring progress, and adjusting plans as needed. Participants will either use this program or receive standard education on CF management. The trial seeks individuals aged 13 to 25 who have CF, are medically stable, and are not currently experiencing a CF flare-up.

As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance CF management for others.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this mobile health platform is safe for adolescents and young adults with Cystic Fibrosis?

Research has shown that mobile health platforms like NUDGE help manage long-term health conditions. These platforms assist users in setting and tracking goals and provide feedback on their progress. For cystic fibrosis, the NUDGE program monitors participants' progress and ensures their safety.

Although specific data on the safety of NUDGE for cystic fibrosis is not available, similar apps have been safely used for conditions like diabetes. This trial is labeled "Not Applicable" for phase, indicating no serious safety issues are expected with the NUDGE program, as it is a digital tool, not a medication or surgery.

Mobile health tools are generally considered safe because they primarily involve using a smartphone app to guide health activities. Participants are usually closely monitored, allowing for quick resolution of any problems. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Mobile Health Platform for Cystic Fibrosis because it introduces the NUDGE program, a unique approach focusing on digital health solutions. Unlike traditional treatments that rely heavily on medications and physical therapy, NUDGE leverages mobile technology to provide personalized education and support. This platform aims to enhance self-management for patients by offering tailored health guidance and tracking, potentially leading to better adherence to treatment plans and improved quality of life. By integrating digital tools into patient care, this method offers a modern, accessible way to support individuals with cystic fibrosis.

What evidence suggests that the NUDGE platform is effective for increasing physical activity in adolescents and young adults with Cystic Fibrosis?

Research has shown that mobile health platforms can help people with cystic fibrosis improve their health habits and outcomes. This trial will compare two approaches: the NUDGE platform and an education-based approach. Studies have found that digital tools like NUDGE, which assist in setting and tracking health goals, enhance self-care and patient-focused results. These tools effectively motivate physical activity and help reach health targets. Additionally, evidence suggests that mobile health (mHealth) interventions can lead to better health outcomes, such as improved control of conditions like blood pressure and cholesterol. While NUDGE is specifically designed for young people with cystic fibrosis, its method has shown promise in encouraging healthier lifestyles and better disease management. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adolescents and young adults aged 13-25 with Cystic Fibrosis who are medically stable, can communicate in English, and aren't currently having a CF-related health crisis. It aims to help those already active stay that way or encourage less active individuals to increase their physical activity.

Inclusion Criteria

Speaks and reads English

I am between 13 and 25 years old.

I have been diagnosed with cystic fibrosis or a related disorder.

Exclusion Criteria

I have a health condition that prevents me from being physically active.

Have any oxygen, CPAP or BiPAP requirement

I do not have cognitive issues that would stop me from completing the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Completion of baseline study measures and return of actigraphy monitors

1 week

1 visit (in-person)

Treatment

Participants receive the NUDGE intervention content for 6 months

6 months

3 visits (in-person) at Months 0, 3, and 6

Delayed Treatment

Control group receives NUDGE intervention after Month 3

3 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

What Are the Treatments Tested in This Trial?

Interventions

• NUDGE

Trial Overview The intervention being tested is a mobile app called NUDGE designed for smartphones. It's a chatbot that helps set fitness goals, monitor progress, give feedback on achievements, and adjust future objectives based on evidence-based strategies.

How Is the Trial Designed?

Group I: NUDGE Experimental Treatment 1 Intervention

Group II: Education Active Control 1 Intervention

Who Is Running the Clinical Trial?

Nemours Children's Clinic

Lead Sponsor

Trials

128

Recruited

18,000+

Cystic Fibrosis Foundation

Collaborator

Trials

199

Recruited

37,800+

Published Research Related to This Trial

The pilot randomized controlled trial successfully recruited 64 participants (33 in the intervention group and 31 in the control group) within the target timeframe, demonstrating the feasibility of a larger study to improve medication adherence in people with cystic fibrosis.

Participants in the intervention group showed a 10% greater improvement in medication adherence and a 5% increase in FEV1 percent predicted compared to the control group, indicating potential efficacy of the intervention despite some challenges in delivering the full program.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Supporting medication adherence for adults with cystic fibrosis: a randomised feasibility study. Hind, D., Drabble, SJ., Arden, MA., et al.[2023]

In a study involving 88 early childhood education centers, incorporating nudge strategies into workshop invitations did not significantly increase registration rates compared to generic invitations, with only 25% of the intervention group registering versus 20% in the control group.

The study found no significant differences in invitation recall or acceptability between the two groups, suggesting that low-intensity behavioral nudges may not be effective in promoting participation in nutrition education workshops.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of Nudge Strategies on Nutrition Education Participation in Child Care: Randomized Controlled Trial. Grady, A., Barnes, C., Lum, M., et al.[2021]

Health-enhancing nudges, which aim to influence people's choices for better health, often fail because they do not consider the holistic understanding of individual health and can lead to negative emotional responses like resentment and anger.

These nudges can be detrimental to health as they assume people lack the ability to make their own choices, which can undermine their agency and lead to increased health risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Why Health-enhancing Nudges Fail. Schramme, T.[2023]

A review of 17 studies on nudging interventions for children aged 2-12 revealed that most efforts focused on increasing physical activity, with very few targeting sedentary behavior or sleep, indicating a significant gap in research.

Most studies reported positive effects and utilized multicomponent interventions, but there is a need for more research specifically on nudges alone to effectively improve children's lifestyle behaviors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nudging interventions to improve children's sleep, physical activity and sedentary behavior: A scoping review. Diamant, É., Perez, T., Drouin, O.[2023]

A randomized controlled trial involving 402 cystic fibrosis patients will assess the effectiveness of telemonitoring combined with behavior change interventions over 18 months, focusing on adherence to inhalation therapies and lung function.

The primary goal is to determine if continuous monitoring and support can reduce the time to the first pulmonary exacerbation, which is crucial for improving patient outcomes in cystic fibrosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A multi-centre, randomized, controlled trial on coaching and telemonitoring in patients with cystic fibrosis: conneCT CF. Thee, S., Stahl, M., Fischer, R., et al.[2021]

A pilot study involving 36 cystic fibrosis patients tested a new management process for pulmonary exacerbations (PEx) using connected devices and personalized education, with 27 patients completing the educational phase.

The study aims to improve early detection and management of PEx by equipping patients with tools and knowledge to react promptly, potentially enhancing self-management and care team collaboration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of Home-Based Connected Devices in Patients With Cystic Fibrosis for the Early Detection and Treatment of Pulmonary Exacerbations: Protocol for a Qualitative Study. Morsa, M., Perrin, A., David, V., et al.[2021]

Nudges, which are small changes in the environment or information presentation, can significantly improve patient outcomes in healthcare by influencing behaviors.

To effectively implement nudges, it is crucial to systematically design them to fit clinical workflows, engage relevant stakeholders, and conduct rapid experimentation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Designing Nudges for Success in Health Care. Harrison, JD., Patel, MS.[2021]

Non-adherence to treatment is a significant issue in healthcare, costing the US over $100 billion annually in avoidable healthcare expenses and an additional $230 billion in lost productivity.

The proposed framework combines gamification techniques with real-world rewards to enhance patient motivation and adherence, implemented through modifications to a health tracking app and video feedback on potential rewards.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Increasing Health Care Adherence Through Gamification, Video Feedback, and Real-World Rewards. Saric, K., Redd, C., Varnfield, M., et al.[2020]

The smartphone app developed for adults with cystic fibrosis (CF) helped reduce the time it took to detect respiratory exacerbations that required antibiotics, with a median detection time of 70 days compared to 141 days in the control group.

While the app did not significantly affect the number of intravenous (IV) antibiotic courses used, it was associated with an increase in oral antibiotic courses, indicating a potential shift in treatment approach rather than a reduction in antibiotic use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A smartphone application for reporting symptoms in adults with cystic fibrosis improves the detection of exacerbations: Results of a randomised controlled trial. Wood, J., Jenkins, S., Putrino, D., et al.[2021]

Citations

1. withpower.com withpower.com/trial/mobile-health-platform-for-cystic-fibrosis-a968b

Mobile Health Platform for Cystic Fibrosis (NUDGE Trial) A randomized controlled trial involving 402 cystic fibrosis patients will assess the effectiveness of telemonitoring combined with behavior change interventions ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12138008/

Developing a data-enabled nudge intervention for ... Our data-driven intervention incorporates this antibiotic exposure data as a nudge that prompts clinicians to consider a non-antibiotic strategy ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06958094

Effectiveness of Gamified Mobile Health Apps for Airway ... The aim of this randomized controlled trial is to evaluate the effectiveness of gamified mobile health (mHealth) applications for airway clearance therapy ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37085386/

Impact on patient-centered care outcomes Mobile health platform for self-management of pediatric cystic fibrosis: Impact on patient-centered care outcomes. J Cyst Fibros. 2023 Apr 19 ...

5. researchgate.net researchgate.net/publication/388680249_The_impact_of_mobile_health_interventions_on_service_users'_health_outcomes_and_the_role_of_health_professions_a_systematic_review_of_systematic_reviews

(PDF) The impact of mobile health interventions on service ... mHealth interventions showed positive impacts on clinical outcomes, such as reductions in blood pressure, HbA1c, and cholesterol.

6. jmir.org jmir.org/2021/1/e16842/

Sharing Patient-Controlled Real-World Data Through the ... This study aimed to propose a conceptual model that describes how patient-controlled real-world data can be shared effectively in chronic care management.

7. mdpi.com mdpi.com/1424-8220/22/12/4620

A Nudge-Inspired AI-Driven Health Platform for Self- ... In this paper, we propose, develop, and implement a nudge-inspired artificial intelligence (AI)-driven health platform for self-management of diabetes.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7872830/

A Mobile Health Platform for Self-Management of Pediatric ... The aim of this study is to adapt a mobile health (mHealth) app originally developed in Sweden to the needs of patients, families, and health care providers in ...