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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Kintsugi | Other | Enrolled participants who will be using the Kintsugi voice journaling phone application. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Kintsugi voice journaling application | Other | Participants will use the Kintsugi voice journaling phone application for three months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Change in PHQ-9 (Patient Health Questionnaire-9) Scores |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jordana Hoppe, MD | Children's Hospital Colorado | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital Colorado | Aurora | Colorado | 80045 | United States |
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| ID | Term |
|---|---|
| D003550 | Cystic Fibrosis |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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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 |
| D030342 |
| Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |