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Voice Journaling Application for Cystic Fibrosis

N/A

Waitlist Available

Led By Jordana Hoppe, MD

Research Sponsored by University of Colorado, Denver

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of cystic fibrosis based on sweat chloride (≥60) or two known disease-causing mutations

Age 14 - 18 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months

Awards & highlights

Study Summary

This trial is testing a journaling app for adolescents with CF. The goal is to see if it is feasible and acceptable, and if it impacts key clinical outcomes.

Who is the study for?

This trial is for adolescents aged 14-18 with cystic fibrosis, who have had signs of anxiety or depression in the past year. They must be stable health-wise, not on acute illness antibiotics recently but can be on routine treatments. Participants need access to an iOS device and speak English. Those with suicidal thoughts, cognitive delays preventing app use, non-English proficiency, participation in another mental health study or active mental health treatment are excluded.Check my eligibility

What is being tested?

The Kintsugi voice journaling application is being tested to see if it's practical and liked by teenagers with cystic fibrosis and to check its effect on their clinical outcomes. This pilot study will help design future research based on these initial findings.See study design

What are the potential side effects?

Since this trial involves a voice journaling app rather than medication, traditional physical side effects aren't expected. However, participants may experience emotional discomfort while reflecting upon personal experiences during journaling.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with cystic fibrosis.

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I am between 14 and 18 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Kintsugi Satisfaction

Kintsugi Usage

Secondary outcome measures

Change in GAD-7 (Generalized Anxiety Disorder-7) Scores

Change in PHQ-9 (Patient Health Questionnaire-9) Scores

Trial Design

1Treatment groups

Experimental Treatment

Group I: KintsugiExperimental Treatment1 Intervention

Enrolled participants who will be using the Kintsugi voice journaling phone application.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Colorado, DenverLead Sponsor

1,732 Previous Clinical Trials

2,143,518 Total Patients Enrolled

16 Trials studying Cystic Fibrosis

863 Patients Enrolled for Cystic Fibrosis

Jordana Hoppe, MDPrincipal InvestigatorChildren's Hospital Colorado

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are patient participants still being enrolled in this research endeavor?

"This medical experiment, which was launched on July 29th 2022 and edited most recently on August 12th, is still recruiting participants according to clinicaltrials.gov's records."

Answered by AI

How many individuals have signed up for participation in this clinical trial?

"Affirmative. According to clinicaltrials.gov, this research project is presently recruiting individuals; the trial was initially posted on July 29th 2022 and recently updated on August 12th 2022. In total, 30 participants are needed for the single medical centre taking part in this investigation."

Answered by AI

Could you elucidate if this clinical trial is accepting participants below the age of 40?

"Eligible participants must fall between the age of 14 and 18 in order to partake in this study. Clinicialtrials.gov houses 79 studies for minors, and 379 trials targeting seniors past 65 years old."

Answered by AI

Could I be a participant in this experiment?

"This clinical trial is recruiting 30 adolescents aged 14-18 with cystic fibrosis. To be eligible, participants must meet the following qualifications: Diagnosis of CF based on sweat chloride (≥60) or two known disease-causing mutations, Elevated GAD-7 and/or PHQ-9 scores in the past year, Clinically stable for at least 2 weeks prior to enrollment without increased respiratory and/or GI symptoms, Accessible iOS device and internet plan, Parental consent if under 18 years old, English speakers who are willing to participate after informed consent has been obtained."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Pilot Study to Evaluate a Voice Journaling Application in Adolescents With Cystic Fibrosis

2022. "Pilot Study to Evaluate a Voice Journaling Application in Adolescents With Cystic Fibrosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05420844.

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