Evaluation of an Incentive-based Intervention to Improve 90-day Adherence in PAP-Naive Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- ResMed
- 入组人数
- 166
- 试验地点
- 2
- 主要终点
- Mean PAP Usage at 90 Days
研究概览
简要总结
This is a prospective, randomized, open-label study to evaluate effectiveness of applying financial and social incentives via a smartphone-based app in helping participants achieve adherence to PAP therapy.
详细描述
This is a prospective, randomized, two-arm, open-label study to evaluate effectiveness of applying financial and social incentives via a smartphone-based app in helping participants achieve adherence to therapy. Randomization will include an allocation ratio of 2:1 (control:treatment).
Participants will be recruited based on evidence that they are struggling to achieve adherence to therapy after the first 3 nights of usage. Two 'site to participant' contacts are required during this study. These contacts can either occur at the clinical site or remotely (e.g., by telephone). During the initial contact, their interest in the study and eligibility will be confirmed, then they will be consented, asked to complete the Baseline Questionnaire, and their demographic information will be collected on case report forms (CRFs).
Participants randomized to the intervention (Group B) will be provided with information and assistance in downloading Restful to their smartphone and registering with Wellth.
At the final contact (90 days), the participant will be asked to complete an End of Study Questionnaire and the investigative staff will collect PAP therapy data for the trial period and record it on CRFs. Participants in Group B will have access to the Restful app discontinued. This completes the participant's active participation in the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult participants (≥ 18 years of age)
- •New diagnosis of OSA
- •Prescribed CPAP or APAP for treatment of OSA
- •Prescribed a ResMed flow generator compatible with AirView
- •Owns a smart phone and is willing to download an app on their phone
- •Willing and able to give informed consent
- •Can read and comprehend written and spoken English
排除标准
- •Have used PAP therapy in the past
- •Have been prescribed bi-level or adaptive servo-ventilation therapy
- •Are participating in another app-based research study
- •Cannot participate for the full duration of the study (at least 90 days)
- •Participants who have a medical history or concurrent illness that the investigator considers sufficiently serious to interfere with the conduct, completion, or results of this study, or constitutes an unacceptable risk to the participant for the duration of the study
结局指标
主要结局
Mean PAP Usage at 90 Days
时间窗: 90 days
Average nightly CPAP use for the 90 day time frame.
次要结局
- Change in FOSQ-10 Questionnaire Scores(90 days)
- % of Participants That Meet Medicare Compliance Standard(90 days)
- Change in ESS Questionnaire Scores(90 days)