Wellness Program for Cystic Fibrosis

Not yet recruiting at 2 trial locations

Overseen By Kristin Riekert, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Disqualifiers: Pulmonary exacerbation, Pregnant, Contraindication, others

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

Compensation: Varies

Number of Visits: 8

Duration: 15 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a special wellness program can help people with cystic fibrosis feel less tired, sleep better, and be more active compared to usual care. Participants in the treatment group will receive written materials and up to eight coaching sessions focused on reducing fatigue and improving overall well-being. The trial seeks adults with cystic fibrosis who often feel fatigued and have access to a smartphone or computer.

As an unphased trial, this study provides a unique opportunity to explore new methods for enhancing well-being and managing fatigue.

Do I need to stop my current medications for this trial?

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 CF Wellness Program is safe for individuals with cystic fibrosis?

Research has shown that wellness programs like the CF Wellness Program (CFWP) are generally safe for individuals, including those with cystic fibrosis. The CFWP includes coaching sessions that focus on managing tiredness, staying active, and improving mental health. Studies on similar programs have not identified any serious side effects.

While specific safety data for the CF Wellness Program itself may be limited, similar wellness and coaching programs typically have few side effects. Participants often do well with these programs because they emphasize lifestyle and behavior changes instead of medication. However, it is important to consider personal health and consult a doctor before starting any new program. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the CF Wellness Program because it goes beyond standard medical treatments for cystic fibrosis, which typically focus on managing lung infections and nutritional needs. This program uniquely targets overall well-being by providing personalized support through written materials and coaching sessions. Participants receive guidance on managing fatigue, increasing physical activity, and improving mental health, all delivered conveniently via video chat or phone. By addressing these aspects, the program aims to enhance quality of life for adults with cystic fibrosis in ways that traditional treatments may not.

What evidence suggests that the CF Wellness Program could be effective for cystic fibrosis?

Research has shown that the Cystic Fibrosis Wellness Program (CFWP), which participants in this trial may receive, might help reduce tiredness, improve sleep, and increase physical activity in people with cystic fibrosis. Early results suggest that participants find the program easy to follow and are likely to continue with it. The program offers personalized coaching sessions that focus on managing tiredness, exercising, and mental health. Although it's still early, combining coaching with written materials seems promising for improving overall health in people with cystic fibrosis. More studies are needed to confirm these benefits, but the initial results are encouraging. ^{3 6 7 8 9}

Who Is on the Research Team?

Kristin Riekert, PhD

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

This trial is for individuals with Cystic Fibrosis who experience fatigue, poor sleep quality, or lead a sedentary lifestyle. Participants should be willing to complete wellness program coaching sessions and assessments.

Inclusion Criteria

Access to a smartphone, tablet, and/or computer with access to internet

Documentation of CF diagnosis in the medical record

Ability to understand/read/speak English

Exclusion Criteria

Pregnant or <6 months post-partum

Contraindication to light physical activity

Participated in the CFWP Feasibility Study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants complete baseline assessments including fitness tracker data collection

1 week

Treatment

Participants receive the CFWP intervention with up to 8 coaching sessions over 15 weeks

15 weeks

8 virtual sessions

Follow-up

Participants are monitored for intervention adherence and data quality at Week 15

1 week

What Are the Treatments Tested in This Trial?

Interventions

• CF Wellness Program

Trial Overview The study tests the Cystic Fibrosis Wellness Program (CFWP) against usual care to see if it improves adherence to treatment, retention in the study, data quality from fitness trackers, reduces fatigue and sedentary behavior, and enhances sleep and physical activity.

How Is the Trial Designed?

Group I: Treatment Group Experimental Treatment 1 Intervention

Adults With Cystic Fibrosis (AWCF) randomized to the intervention will receive the CFWP written materials and be offered up to 8 coaching sessions tailored to fatigue, physical activity, and mental well-being. The sessions will last approximately 45 - 60 minutes and be delivered either by web-based video chat (e.g., Zoom) or by telephone.

Group II: Usual Care Active Control 1 Intervention

Usual clinical care

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

Boston Children's Hospital, Boston, MA, USA

Collaborator

Trials

4

Recruited

2,600+

National Jewish Health

Collaborator

Trials

145

Recruited

318,000+

Cystic Fibrosis Foundation

Collaborator

Trials

199

Recruited

37,800+

Citations

1. centerwatch.com centerwatch.com/clinical-trials/listings/NCT07071324/cf-wellness-program

CF Wellness Program | Clinical Research Trial Listing Highly effective modulator therapy (HEMT) has improved lung health for many adults with cystic fibrosis (CF), but does not appear to have ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04809207

Acceptability, Feasibility and Preliminary Efficacy of CFWP ... This study aims to test the acceptability, feasibility and preliminary efficacy of a tailored intervention known as the CF Wellness Program (CFWP) to treat ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8660127/

Real-World Outcomes in Cystic Fibrosis Telemedicine ... The global pandemic presented an unprecedented opportunity to assess the impact of telemedicine on clinical outcomes in cystic fibrosis (CF).

4. clinconnect.io clinconnect.io/trials/NCT07071324

CF Wellness Program (NCT07071324) - ClinConnect This study is a pilot randomized control trial (RCT; N=80) comparing the Cystic Fibrosis Wellness Program (CFWP) to usual care (UC) to evaluate (1) ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1569199325000013

Impact of CFTR modulator therapy on basic life needs and ... In this large survey of PwCF taking and not taking CFTR-M, most respondents experienced no change in their basic life needs and financial well-being.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37918520/

Predictors of Transition Outcomes in Cystic Fibrosis - PubMed Patients from CF centers with greater rates of CF RISE engagement had improved lung function and weight at their first adult outpatient visit.

7. cff.org cff.org/managing-cf/care-center-data

Care Center Data Current data on key measures at each center and for the past five years are available to all users of cff.org. The CF Foundation also publishes annual data ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT03434886

Outcomes in CF Patients Accessing Their Registry Health ... The study aims are to examine the effect of patient access to C View on a range of clinical outcomes, health service usage, health literacy and patient reported ...

9. shieldshealthsolutions.com shieldshealthsolutions.com/content/uploads/2024/08/ASHP-Futures-2024-CF-Poster_FINAL.pdf

Clinical Outcomes in Cystic Fibrosis Patients Enrolled in an ... Objectives: To evaluate outcomes in CF patients within a health system specialty pharmacy (HSSP) care model by comparing them to established benchmarks.