Mobile Health Platform for Cystic Fibrosis

(NUDGE Trial)

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Nemours Children's Clinic

Disqualifiers: Neurological condition, Cognitive impairment, Oxygen requirement

No Placebo Group

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to help adolescents and young adults between the ages of 13-25 with Cystic Fibrosis (CF), medically stable, able to speak and read English, and are not experiencing a CF - related exacerbation, who are already active to remain, or gradually encourage them to increase their levels of physical activity Participants will be asked to utilize a smartphone program, called NUDGE that we have developed. NUDGE is a chatbot with evidence-based features known to help teens make progress toward health goal: * Set and review goals * Self-monitor progress * Provide feedback on goal attainment * Revise future goals

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 data supports the effectiveness of the treatment NUDGE for cystic fibrosis?

Research shows that using digital tools like smartphone apps and connected devices can help detect and manage lung problems early in people with cystic fibrosis. These tools, combined with behavior change techniques, improve adherence to treatment and can lead to better health outcomes. ^{1 2 3 4 5}

How is the NUDGE treatment for cystic fibrosis different from other treatments?

The NUDGE treatment is unique because it uses a mobile health platform to subtly influence patients' behaviors, potentially improving adherence to treatment plans through gamification and real-world rewards, unlike traditional cystic fibrosis treatments that focus solely on medication or physical therapies. ^{3 6 7 8 9}

Research Team

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• NUDGE (Behavioral Intervention)

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.

Participant Groups

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+

R. Lawrence Moss

Nemours Children's Clinic

Chief Executive Officer since 2018

MD, FACS, FAAP

Matthew Davis

Nemours Children's Clinic

Chief Medical Officer since 2023

MD, MAPP

Cystic Fibrosis Foundation

Collaborator

Trials

199

Recruited

37,800+

Michael P. Boyle

Cystic Fibrosis Foundation

Chief Executive Officer since 2019

MD from Johns Hopkins University

Albert Faro

Cystic Fibrosis Foundation

Chief Medical Officer since 2023

MD

Findings from Research

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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

A multi-centre, randomized, controlled trial on coaching and telemonitoring in patients with cystic fibrosis: conneCT CF. [2021]

2. Canada 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. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Designing Nudges for Success in Health Care. [2021]

4. Netherlands 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. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Supporting medication adherence for adults with cystic fibrosis: a randomised feasibility study. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Nudging interventions to improve children's sleep, physical activity and sedentary behavior: A scoping review. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Impact of Nudge Strategies on Nutrition Education Participation in Child Care: Randomized Controlled Trial. [2021]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Why Health-enhancing Nudges Fail. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Increasing Health Care Adherence Through Gamification, Video Feedback, and Real-World Rewards. [2020]