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

Primary Purpose

Cystic Fibrosis

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Kintsugi voice journaling application

About this trial

This is an interventional other trial for Cystic Fibrosis

Eligibility Criteria

14 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Children's Hospital ColoradoRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Kintsugi

Arm Description

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

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

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.

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.

Full Information

NCT ID

NCT05420844

First Posted

May 18, 2022

Last Updated

September 11, 2023

Sponsor

University of Colorado, Denver

1. Study Identification

Unique Protocol Identification Number

NCT05420844

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Recruiting

Study Start Date

July 29, 2022 (Actual)

Primary Completion Date

December 2023 (Anticipated)

Study Completion Date

December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Colorado, Denver

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cystic Fibrosis

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Kintsugi

Arm Type

Other

Arm Description

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

Intervention Type

Other

Intervention Name(s)

Kintsugi voice journaling application

Intervention Description

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

Primary Outcome Measure Information:

Title

Kintsugi Usage

Description

Time Frame

3 Months

Title

Kintsugi Satisfaction

Description

Time Frame

3 Months

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

3 Months

Title

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

Description

The PHQ-9 (Patient Health Questionnaire-9 measures depression severity. Possible scores range from 0 to 27, with higher scores indicating a worse outcome.

Time Frame

3 Months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

14 Years

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jordana Hoppe, MD

Phone

720-777-6550

jordana.hoppe@childrenscolorado.org

First Name & Middle Initial & Last Name or Official Title & Degree

Allison Keck, BS

Phone

720-777-0734

allison.keck@childrenscolorado.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jordana Hoppe, MD

Organizational Affiliation

Children's Hospital Colorado

Official's Role

Principal Investigator

Facility Information:

Facility Name

Children's Hospital Colorado

City

Aurora

State/Province

Colorado

ZIP/Postal Code

80045

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jordana Hoppe, MD

Phone

720-777-6550

jordana.hoppe@childrenscolorado.org

First Name & Middle Initial & Last Name & Degree

Jordana Hoppe, MD

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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