Pilot Study to Evaluate the Feasibility and Acceptability of a Voice Journaling Application in Adolescents With Cystic Fibrosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Kintsugi Usage
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Kintsugi Usage
时间窗: 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
时间窗: 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.
次要结局
- Change in GAD-7 (Generalized Anxiety Disorder-7) Scores(3 Months)
- Change in PHQ-9 (Patient Health Questionnaire-9) Scores(3 Months)