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

Cystic Fibrosis Clinical Trial

Official title:

Pilot Study to Evaluate the Feasibility and Acceptability of a Voice Journaling Application in Adolescents With Cystic Fibrosis

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05420844
• Other study ID #: 21-4821
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 29, 2022
• Est. completion date: December 2024

Study information

• Verified date: January 2024
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: December 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 18 Years

Eligibility

Inclusion Criteria:

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

2. Age 14 - 18 years

3. History of elevated GAD-7 and/or PHQ-9 on screening questionnaires completed during routine CF clinical visits within the past year

4. 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

5. Access to an iOS device (iPhone or iPad) and internet/data plan

6. Parent/participant enrolled in MyChart

7. Willing to participate in study after informed consent and assent has been obtained

8. English speaking

Exclusion Criteria:

1. Endorsement of suicidal ideation on the baseline PHQ-9 (item 9) questionnaire at the enrollment visit

2. Developmental or cognitive delay preventing participant from interacting with voice journaling app

3. Unable to speak and write proficiently in English

4. Enrollment in another behavioral health study

5. Actively in treatment with a mental health provider

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

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

Locations

Country	Name	City	State
United States	Children's Hospital Colorado	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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.	3 Months
Secondary	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.	3 Months