Personalized Mobile Health Platform to Promote Physical Activity in Adolescents and Young Adults With Cystic Fibrosis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Recruitment
研究概览
简要总结
The goal of this clinical trial is to help adolescents and young adults between the ages of 13-25 with Cystic Fibrosis (CF), medically stable, able to speak and read English, and are not experiencing a CF - related exacerbation, who are already active to remain, or gradually encourage them to increase their levels of physical activity
Participants will be asked to utilize a smartphone program, called NUDGE that we have developed. NUDGE is a chatbot with evidence-based features known to help teens make progress toward health goal:
- Set and review goals
- Self-monitor progress
- Provide feedback on goal attainment
- Revise future goals
详细描述
The goal of this study is to conduct a 6-month delayed treatment pilot Trial with adolescents and young adults (AYA) ages 13-25 with Cystic Fibrosis (CF) or a CF related disorder) to establish feasibility and obtain data necessary to inform a Phase III efficacy trial. AYAs 18 years-old and caregivers of AYAs 13-17 years-old will complete the informed consent process. AYAs 13-17 years-old will be asked to assent to participate in the study. After completion of the baseline study measures and return of actigraphy monitors, staff will notify AYAs of their randomized assignment. AYAs receiving NUDGE will then begin receiving intervention content for 6 months. AYAs randomized to control will receive NUDGE at the conclusion of the Month 3 study visit. Study visits will occur at Months 0, 3, and 6 with staff masked to treatment assignment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 13 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •13-25 years old
- •Has a verified CF diagnosis or CF-related disorder
- •Medically stable (i.e., FEV1>30%, not experiencing a CF-related exacerbation)
- •Speaks and reads English
排除标准
- •Have a comorbidity limiting PA participation (e.g., neurological condition)
- •Have a significant cognitive impairment that interferes with study completion
- •Have any oxygen, CPAP or BiPAP requirement
研究组 & 干预措施
NUDGE
干预措施: NUDGE (Behavioral)
Education
干预措施: Education (Other)
结局指标
主要结局
Recruitment
时间窗: Baseline
Recruitment: Our recruitment goal is 30 AYAs with CF.
Retention
时间窗: 3-month
Retention: Our criterion for success is no more than 20% attrition.
Engagement
时间窗: 3-month
Engagement: We will be considered engagement a success if AYAs in NUDGE respond to an average of 4/7 (57%) messages each week during the first 3 months that a participant uses NUDGE.
Acceptability
时间窗: 3-month
Acceptability: We will consider NUDGE acceptable if users report a satisfaction rating of ≥3 (mostly satisfied) on our modified Client Satisfaction Questionnaire and rate it as usable as ≥70% of other computerized systems on the System Usability Scale. We will also be attentive to themes in relation to the barriers and facilitators of using NUDGE and its success in promoting PA in interviews.
次要结局
- Actigraphy(Baseline, 3-month, and 6-month)
- Lung Functioning(Baseline, 3-month, and 6-month)
- CF Quality of Life(Baseline, 3-month, and 6-month)
研究者
David Fedele
Principal Research Scientist
Nemours Children's Clinic