Creating a Mobile Health Program for Teens With Congenital Heart Disease
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Percent of participants with favorable satisfaction and usability ratings (Acceptability)
研究概览
简要总结
The goal of this clinical trial is to learn if teens living with congenital heart disease like and will use Heart2Heart and if it affects how they think and feel about e-cigarettes. Heart2Heart is a website that provides health information for teens with congenital heart disease. The main questions this trial aims to answer are:
- Will teens enroll in the trial and complete the trial activities?
- Do teens use and like Heart2Heart?
- Does using Heart2Heart affect how teens think and feel about e-cigarettes?
Researchers will compare the Heart2Heart group to a group that does not use Heart2Heart to see if it affects teens' thoughts and feelings about e-cigarettes.
Participants will:
- Complete online surveys
- If assigned, explore the Heart2Heart website
- If invited, share their opinions about Heart2Heart in an online discussion
研究设计
- 研究类型
- 干预性
- 分配方式
- 随机
- 干预模型
- 平行分组
- 主要目的
- 预防
- 盲法
- 开放（无盲法）
入排标准
- 年龄范围
- 12 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 12-18 years of age
- diagnosis of structural congenital heart disease
- if under 18, has a parent or legal guardian proficient in English or Spanish
排除标准
- teen not proficient in English
- teen has cognitive impairments that interfere with completion of the study activities
- teen was a participant in one of the Heart2Heart development studies
- teen does not have access to a device that can connect to the internet
- teen is leaving the United States during their study period
研究组 & 干预措施
Treatment-as-Usual
Participants in the control group will not receive access to Heart2Heart.
Heart2Heart
Participants in the intervention group will receive access to Heart2Heart.
干预措施: Heart2Heart (Behavioral)
结局指标
主要结局
Percent of participants with favorable satisfaction and usability ratings (Acceptability)
时间窗: Acceptability will be measured at the post-intervention survey, two weeks after participants are assigned to a study group.
To evaluate acceptability, the percentage of teens with favorable (the highest two ratings on the scale) usability and satisfaction ratings will be calculated.
Percent of participants completing trial activities (Feasibility)
时间窗: Feasibility will be evaluated throughout the recruitment, enrollment, and data collection process, lasting a period of three months.
The following aspects of feasibility will be evaluated: recruitment rate (number enrolled/number invited), retention rate (number completing trial activities/number randomized to a group), and assessment completion rate (percent of participants completing the trial surveys).
次要结局
未报告次要终点
研究者
研究点 (1)
标识符
- NCT 编号
- NCT07764510
- 其他研究编号
- STUDY#00003377, K23HL166771
日期
- 首次提交
- (上个月)
- 首次发布
- (上个月)
- 主要完成日期
- (明年)
- 研究完成日期
- (明年)
- 最近核实
- (2个月前)
- 最近更新
- (上个月)
监管与共享
- FDA 监管药物
- 否
- FDA 监管器械
- 否
- 个体参与者数据共享计划
- 否
- 是否有结果
- 否