Personalized Approach To Habits - Sleep
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Knowledge Posttest Score
研究概览
简要总结
Two arm study, intervention and control, to explore the impact of an app to help high risk teens with asthma improve their sleep
详细描述
The investigators will use a randomized, two-group, pretest/posttest design to test the efficacy of the Personalized Approach To Habits - Sleep (PATH-S app) and explore the following research question: To what extent does exposure to the PATH-S app increase teens' knowledge, cues to action, perceived sleepiness, and self-efficacy related to improving sleep?
PATH-S will use casual gaming and intermittent reinforcement techniques to encourage teens to adopt and persist with personalized habits to improve sleep duration. Researchers worked with subject matter experts, physicians, and the intended audience to ensure the PATH-S app reflects the specific needs of high risk teens with asthma; minimize counter-productive duplications of services and resource expenditure; and create empowered opportunities for teens to improve their overall sleep and habits.
The Principal Investigator (PI), with input from the subject matter experts and physicians, developed necessary research materials, including the recruitment protocols, evaluation instrumentation, and human subjects consent materials . The PI also outlined the appropriate statistical analysis methods. All procedure documents were reviewed by the KDH Research & Communication (KDHRC) Institutional Review Board before the evaluation launch.
Investigators will recruit participants through evaluation partners who will disseminate the study information to teens via electronic notifications and flyers. Evaluation partners include national asthma organizations. The notifications and flyers provide information about the goal of the study, participant eligibility, and a link to an eligibility form. Once a potential participant completes the eligibility form and s/he is eligible for the study, they will receive a link to a consent form located on a secure online platform.
After consent and enrollment into the study, teens will complete a pretest survey and be randomly assigned to the intervention or control group. The intervention group will be exposed to the PATH-S app, with educational material, and will complete an online posttest survey after 28 days. The control group participants will be exposed to a cloned copy of the PATH-S app, but without the educational material, and will complete an online posttest survey after 28 days. Participant responses to pretest and posttest survey measures will be linked using non-personal identifiers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Must be between 14 and 17 years old.
- •Have an asthma diagnosis from a healthcare provider.
- •Speak and understand English.
- •Have access to a computer and the Internet.
- •Have a smartphone and the ability to download and use an app.
- •Live in the United States.
排除标准
- 未提供
研究组 & 干预措施
PATH-S Treatment
Teens in the treatment group will be exposed to the educational material on the PATH-S app. They will engage with the app, log daily habits and sleep, and complete pretest and posttest assessments to measure changes in their knowledge, attitudes, intentions and self-efficacy.
干预措施: PATH-S app (Behavioral)
Control
Teens in the control group will not be exposed to the educational material on the PATH-S app. They will engage with the app, continue their usual schedules without the additional educational material, and complete pretest and posttest assessments to measure changes in their knowledge, attitudes, intentions and self-efficacy.
结局指标
主要结局
Knowledge Posttest Score
时间窗: Posttest- 28 days
Investigators will ask participants 8 multiple choice knowledge questions related to sleep health and habits which investigators will average to create a composite knowledge score for each participant ranging from 0 to 100. A score of 0 means a participant got zero questions correct while a score of 100 means a participant got all questions correct. Investigators will average these composite scores across all participants for both groups to create mean scores ranging from 0 to 100, the higher the score the more questions participants answer correctly.
Cues to Action Pretest Score
时间窗: Baseline
Investigators will ask participants 9 Likert-type scale questions to measure cues to action, where they rate their level of agreement with various statements. Each answer choice rating will range from 1 to 10, with higher ratings representing higher perceptions of cues to action. Investigators will average ratings from each question to create an average composite rating for each participant ranging from 1 to 10, with 1 being the lowest score and 10 being the highest. Higher score means better outcome. Then, investigators will average these composite scores for each group.
Knowledge Pretest Score
时间窗: Baseline
Investigators will ask participants 8 multiple choice knowledge questions related to sleep health and habits which investigators will average to create a composite knowledge score for each participant ranging from 0 to 100. A score of 0 means a participant got zero questions correct while a score of 100 means a participant got all questions correct. Investigators will average these composite scores across all participants for both groups to create mean scores ranging from 0 to 100, the higher the score the more questions participants answer correctly.
Cues to Action Posttest Score
时间窗: Posttest- 28 days
Investigators will ask participants 9 Likert-type scale questions to measure cues to action, where they rate their level of agreement with various statements. Each answer choice rating will range from 1 to 10, with higher ratings representing higher perceptions of cues to action. Investigators will average ratings from each question to create an average composite rating for each participant ranging from 1 to 10, with 1 being the lowest score and 10 being the highest. Higher score means better outcome. Then, investigators will average these composite scores for each group.
Self-efficacy Pretest Score
时间窗: Baseline
Investigators will ask participants 6 Likert-type scale questions related to perceived self-efficacy with improving sleep health. Each rating will range from 1 to 10, with higher ratings representing higher perceptions of confidence in improving sleep health. Investigators will average ratings from each question to create an average composite rating for each participant ranging from 1 to 10, with 1 being the lowest possible score and 10 being the highest score. Higher scores mean better outcomes. Then, investigators will average these composite scores for both groups.
Self-efficacy Posttest Score
时间窗: Posttest- 28 days
Investigators will ask participants 6 Likert-type scale questions related to perceived self-efficacy with improving sleep health. Each rating will range from 1 to 10, with higher ratings representing higher perceptions of confidence in improving sleep health. Investigators will average ratings from each question to create an average composite rating for each participant ranging from 1 to 10, with 1 being the lowest possible score and 10 being the highest score. Higher scores mean better outcomes. Then, investigators will average these composite scores for both groups
Sleepiness/Restfulness Pretest Score
时间窗: Baseline
Investigators will ask participants 5 Likert-type scale questions related to perceived sleepiness or tiredness during different situations. Each rating will range from 1 to 4, with higher ratings representing higher perceptions of tiredness. Investigators will average ratings from each question to create an average composite rating for each participant ranging from 1 to 4, with 1 being the lowest possible score and 4 being the highest score. Lower scores mean better outcomes. Then, investigators will average these composite scores for both groups.
Sleepiness/Restfulness Posttest Score
时间窗: Posttest- 28 days
Investigators will ask participants 5 Likert-type scale questions related to perceived sleepiness or tiredness during different situations. Each rating will range from 1 to 4, with higher ratings representing higher perceptions of tiredness. Investigators will average ratings from each question to create an average composite rating for each participant ranging from 1 to 4, with 1 being the lowest possible score and 4 being the highest score. Lower scores mean better outcomes. Then, investigators will average these composite scores for both groups.
次要结局
- Satisfaction at Posttest Score(Posttest- 28 days)