Cystic FibrosisNCT05420844
Pilot Study to Evaluate a Voice Journaling Application in Adolescents With Cystic Fibrosis
A study testing Kintsugi voice journaling application in people with Cystic Fibrosis, run by University of Colorado, Denver at 1 site in United States.
Trial summary
The overall goal of this pilot study is to evaluate the feasibility and acceptability of the Kintsugi voice journaling app in adolescents with CF to inform the design of future observational and interventional trials. Read more about this study
- Who is it for?
- Ages 14 to 18 years
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Kintsugi voice journaling application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jul 2022to 16 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Diagnosis of cystic fibrosis based on sweat chloride (≥60) or two known disease-causing mutations
- Age 14 - 18 years
- History of elevated GAD-7 and/or PHQ-9 on screening questionnaires completed during routine CF clinical visits within the past year
- Clinically stable at the time of enrollment, without increased respiratory and/or GI symptoms or treatment with IV and/or oral antibiotics for an acute illness for the 14 days prior to enrollment visit. Participants receiving inhaled antibiotics every other month are eligible to enroll. Participants receiving chronic oral antibiotics, including thrice weekly azithromycin will be eligible to participate
- Access to an iOS device (iPhone or iPad) and internet/data plan
- Parent/participant enrolled in MyChart
- Willing to participate in study after informed consent and assent has been obtained
- English speaking
Who cannot join
- Endorsement of suicidal ideation on the baseline PHQ-9 (item 9) questionnaire at the enrollment visit
- Developmental or cognitive delay preventing participant from interacting with voice journaling app
- Unable to speak and write proficiently in English
- Enrollment in another behavioral health study
- Actively in treatment with a mental health provider
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital Colorado
Aurora, Colorado, 80045
About this study
Official title: Pilot Study to Evaluate the Feasibility and Acceptability of a Voice Journaling Application in Adolescents With Cystic Fibrosis
The overall goal of this pilot study is to evaluate the feasibility and acceptability of the Kintsugi voice journaling app in adolescents with CF to inform the design of future observational and interventional trials. Additionally, the investigators aim to evaluate the potential impact of the voice journaling app on key clinical outcomes in CF.
- Conditions
- Cystic Fibrosis
- Being tested
- Kintsugi voice journaling application
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kintsugi voice journaling applicationOther
Participants will use the Kintsugi voice journaling phone application for three months.
| Study group | Role | What they receive |
|---|---|---|
| Kintsugi | Other | Enrolled participants who will be using the Kintsugi voice journaling phone application. Receives: Other: Kintsugi voice journaling application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Kintsugi Usage
Establish the feasibility of the Kintsugi voice journaling app in participants. The investigators expect that the use of the voice journaling app will be feasible based on the frequency of use by participants over a three-month period. Frequency will be assessed on number of individual journal entries completed by participants.
Measured: 3 Months
Kintsugi Satisfaction
Establish the acceptability of the Kintsugi voice journaling app in participants. Likert scales will be utilized in the satisfaction survey and the percentage for each answer will be reported to determine acceptability of the application. Possible responses range from "Strongly Disagree" to "Strongly Agree" with "Strongly Agree" indicating a better outcome.
Measured: 3 Months
Secondary outcomes (2)
Change in GAD-7 (Generalized Anxiety Disorder-7) Scores
The GAD-7 (Generalized Anxiety Disorder-7) scale is used for screening, diagnosis and severity assessment of anxiety disorder. Possible scores range from 0 to 21, with higher scores indicating a worse outcome.
Measured: 3 Months
Change in PHQ-9 (Patient Health Questionnaire-9) Scores
The PHQ-9 (Patient Health Questionnaire-9 measures depression severity. Possible scores range from 0 to 27, with higher scores indicating a worse outcome.
Measured: 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2022
- Study start29 Jul 2022
- Primary completion16 Apr 2024
- Study completion16 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jordana Hoppe, MD, Principal investigator, Children's Hospital Colorado
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05420844
- Sponsor's protocol ID
- 21-4821
- Status last verified
- Nov 2025
- First submitted
- 18 May 2022
- Last updated
- 13 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Evaluate the Feasibility and Acceptability of a Voice Journaling Application in Adolescents With Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT05420844
- Acronym / sponsor ID
- 21-4821
- Conditions
- Cystic Fibrosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 29 Jul 2022 (actual)
- Primary completion
- 16 Apr 2024 (actual)
- Study completion
- 16 Apr 2024 (actual)
- First posted
- 15 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overall goal of this pilot study is to evaluate the feasibility and acceptability of the Kintsugi voice journaling app in adolescents with CF to inform the design of future observational and interventional trials. Additionally, the investigators aim to evaluate the potential impact of the voice journaling app on key clinical outcomes in CF.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Kintsugi | Other | Other: Kintsugi voice journaling applicationEnrolled participants who will be using the Kintsugi voice journaling phone application. |
Who may qualify
- Ages
- 14 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- Diagnosis of cystic fibrosis based on sweat chloride (≥60) or two known disease-causing mutations
- Age 14 - 18 years
- History of elevated GAD-7 and/or PHQ-9 on screening questionnaires completed during routine CF clinical visits within the past year
- Clinically stable at the time of enrollment, without increased respiratory and/or GI symptoms or treatment with IV and/or oral antibiotics for an acute illness for the 14 days prior to enrollment visit. Participants receiving inhaled antibiotics every other month are eligible to enroll. Participants receiving chronic oral antibiotics, including thrice weekly azithromycin will be eligible to participate
- Access to an iOS device (iPhone or iPad) and internet/data plan
Key exclusion criteria (5 listed)
- Endorsement of suicidal ideation on the baseline PHQ-9 (item 9) questionnaire at the enrollment visit
- Developmental or cognitive delay preventing participant from interacting with voice journaling app
- Unable to speak and write proficiently in English
- Enrollment in another behavioral health study
- Actively in treatment with a mental health provider
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Kintsugi voice journaling applicationParticipants will use the Kintsugi voice journaling phone application for three months. | Other | Kintsugi |
Primary outcome
Kintsugi Usage
Time frame: 3 Months
Establish the feasibility of the Kintsugi voice journaling app in participants. The investigators expect that the use of the voice journaling app will be feasible based on the frequency of use by participants over a three-month period. Frequency will be assessed on number of individual journal entries completed by participants.
Kintsugi Satisfaction
Time frame: 3 Months
Establish the acceptability of the Kintsugi voice journaling app in participants. Likert scales will be utilized in the satisfaction survey and the percentage for each answer will be reported to determine acceptability of the application. Possible responses range from "Strongly Disagree" to "Strongly Agree" with "Strongly Agree" indicating a better outcome.
2 secondary outcomes
Change in GAD-7 (Generalized Anxiety Disorder-7) Scores
Time frame: 3 Months
Change in PHQ-9 (Patient Health Questionnaire-9) Scores
Time frame: 3 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jordana Hoppe, MD principal investigator
Children's Hospital Colorado
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kintsugi voice journaling application in people with Cystic Fibrosis, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Kintsugi Usage (time frame: 3 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2025; AzTrials last refreshed its copy on 30 Oct 2026.