NCT05420844

Brief 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. Additionally, the investigators aim to evaluate the potential impact of the voice journaling app on key clinical outcomes in CF.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 18, 2022

Completed
28 days until next milestone

First Posted

Study publicly available on registry

June 15, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

July 29, 2022

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 16, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 16, 2024

Completed
Last Updated

November 13, 2025

Status Verified

November 1, 2025

Enrollment Period

1.7 years

First QC Date

May 18, 2022

Last Update Submit

November 11, 2025

Conditions

Cystic Fibrosis

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    3 Months

Secondary Outcomes (2)

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

    3 Months

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

    3 Months

Study Arms (1)

Kintsugi

OTHER

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

Other: Kintsugi voice journaling application

Interventions

Kintsugi voice journaling applicationOTHER

Participants will use the Kintsugi voice journaling phone application for three months.

Kintsugi

Eligibility Criteria

Age14 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, Diseases

Study Officials

  • Jordana Hoppe, MD

    Children's Hospital Colorado

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 18, 2022

First Posted

June 15, 2022

Study Start

July 29, 2022

Primary Completion

April 16, 2024

Study Completion

April 16, 2024

Last Updated

November 13, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)