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Promoting Continuous Positive Airway Pressure (CPAP) Adherence

2014年5月20日 更新者:University of Pennsylvania

Promoting CPAP Adherence and Treatment Outcomes in Patients With Obstructive Sleep Apnea

The proposed research will evaluate new approaches to improving the ability of patients with obstructive sleep apnea (OSA), a breathing disorder during sleep, to use continuous positive airway pressure (CPAP), a medical device worn during sleep to treat OSA. 120 patients with newly diagnosed OSA who are being initiated on CPAP treatment will be assigned to one of 3 groups: usual care, usual care with web-based access to daily CPAP adherence, and usual care with web-based access to daily CPAP adherence and a financial incentive to use CPAP at least 4 hours/day in the first week of treatment. Measures of CPAP use, daytime sleepiness, and quality of life will evaluate whether patients provided web-based access to their daily CPAP adherence with and without financial incentive will have greater objectively measured average daily hours of CPAP use and greater improvement in functional outcomes following 3 months of treatment compared to patients receiving usual care.

The results will test the hypothesis that these behavioral interventions will improve patient adherence to CPAP during the critically important first week of treatment when many patients are deciding whether or not to use CPAP and that this initial level of adherence will be maintained over the long term despite withdrawal of the financial incentive.

研究概览

详细说明

This is a nested clinical study in the NIH funded research project RC2AG036592, "Developing Interactive Technology to Improve Research and Health Behavior". The purpose of the research project is to create a web-based infrastructure to accelerate research in behavioral economics to improve health. Failure to adhere to medical treatments is a major cause of poor outcomes that increase health care spending. Changing unhealthful behaviors is difficult. One barrier to behavioral change is the need to provide patients with immediate, timely information about their behavior. Individual clinicians cannot maintain the frequent contact that is required, but technology and automated feedback mechanisms can keep these issues salient for patients. Internet technology is increasingly seen as an appealing tool to overcome this barrier and promote patient self-management. Recent evidence indicates that providing patients with web-based feedback of their health status may improve adherence to treatment and outcomes.

Another barrier to behavioral change is that people need frequent reinforcement of positive behavior and need that reinforcement often at the time they are making decisions (e.g., to smoke, to overeat, to take medication). Recent studies report that the use of financial incentives is an effective strategy to changing health behavior. Incentives in the form of direct payments provide valuable positive reinforcement and have been shown to change health behavior in a variety of contexts, including weight loss, medication adherence, and smoking cessation. One criticism of this approach to changing health behaviors is whether the new behavior is sustained once the financial incentive is withdrawn.

The proposed clinical study will use the web-based infrastructure that is developed by the research project to evaluate the application of these emerging new approaches in behavioral health intervention to improving CPAP adherence and consequent treatment outcomes in patients with OSA. In the proposed research study, 120 patients with newly diagnosed OSA who are being initiated on CPAP therapy will be randomized to one of three arms: 1) usual care, 2) usual care with the ability of the participant to view reports of his/her daily CPAP use on a password protected website, and 3) usual care with the ability of the participant to view reports of his/her daily CPAP use on a password protected website combined with a daily financial incentive in the first week based of hours per day of CPAP use. The proposed health behavior interventions will 1) provide patients greater access to information about their sleep disordered breathing, and 2) allow patients to become active members of their management team. Aim 1 will determine if the proposed health behavior interventions improve average daily hours of CPAP use in the first week and following 3 months of treatment. The overall hypothesis is that these behavioral interventions will improve patient adherence to CPAP during the critically important first week of treatment when many patients are deciding whether or not to use CPAP and that this initial level of adherence will be maintained over the long term despite withdrawal of the financial incentive.

Interventions designed to improve health-related behavior will only be justified if they lead to greater improvements in clinically relevant outcomes. To determine the impact of the proposed health behavior interventions to increase CPAP adherence on treatment outcomes, Aim 2 will compare measures of daytime function following 3 months of CPAP treatment across the three groups. The results of Aim 2 will demonstrate whether improvements in CPAP adherence due to web-based feedback with or without a financial incentive result in greater improvements in clinical outcomes.

研究类型

介入性

注册 (实际的)

135

阶段

  • 第一阶段早期

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Pennsylvania
      • Philadelphia、Pennsylvania、美国、19104
        • Hospital of the University of Pennsylvania
      • Wynnewood、Pennsylvania、美国、19096
        • Lankenau Medical Center

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Adults 18 years of age or older
  • Apnea-hypopnea index (AHI) ≥ 10 events/hr on full-night in-laboratory polysomnogram (PSG) based on American Academic of Sleep Medicine (AASM) recommended scoring criteria
  • Stable medical history and no change in medications, including anti-hypertensive, thyroid-related, and lipid-lowering medications, in the previous 2 months.
  • Access to a telephone and the internet on all days of the week
  • No regular use (> 3 times/week) of sedative or hypnotic medications in the last 2 months

Exclusion Criteria:

  • Unable or unwilling to provide informed consent
  • Are enrolled in other, ongoing clinical trials
  • Inability to return for follow-up testing
  • Previous diagnosis of another sleep disorder other than obstructive sleep apnea (OSA) (e.g., periodic limb movement disorder [≥ 15 limb movements/hr of sleep with arousal], central sleep apnea [≥ 50% of apneas on diagnostic PSG are central apneas], obesity hypoventilation syndrome, narcolepsy, or night eating syndrome
  • Previous treatment with positive airway pressure, home oxygen therapy, tracheotomy, uvulopalatopharyngoplasty, or other non-nasal surgery for OSA
  • Requiring oxygen or bilevel positive airway pressure for treatment of OSA
  • A clinically unstable medical condition as defined by a new diagnosis or change in medical management in the previous 2 months (e.g., myocardial infarction, congestive heart failure, Cheyne-Stokes breathing, unstable angina, thyroid disease, depression or psychosis, ventricular arrhythmias, cirrhosis, surgery, or recently diagnosed cancer)
  • Systolic BP > 180 mm Hg or diastolic BP > 100 mm Hg following 10 minutes at rest
  • Night shift workers in situations or occupations where they regularly experience jet lag, or have irregular work schedules by history over the last 3 months
  • Unable to perform tests due to inability to communicate verbally, inability to read and write; less than a 5th grade reading level; visual, hearing or cognitive impairment (e.g. previous head injury); or upper extremity motor deficit (e.g., previous stroke that prevents patient from using CPAP treatment)
  • Inability to use CPAP due to claustrophobia, facial pathology, etc.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:卫生服务研究
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
无干预:Usual Care
Usual care for 3 months. This consists of a phone call after one week of treatment, and clinic appointments at the sleep center following one month and three months of CPAP treatment.
实验性的:Web-Access to CPAP Data
Usual care and web-based access to CPAP adherence data for 3 months. Participants in this group will be asked to review their CPAP use daily in the first week of treatment and as desired over the next 3 months by accessing a password protected website.
Participants will have web-based access to their CPAP usage for each 24 hours of treatment. They will be asked to view this data each day during the first week of the study, and then as frequently as they choose after the first week.
实验性的:Web-Access to CPAP Data & Incentive
Usual care and web-based access to CPAP data for 3 months with financial incentives. Participants in this group will be asked to review their CPAP use daily in the first week of treatment and as desired over the next 3 months by accessing a password protected website. Financial incentive terminated after 1 week.
Participants will have web-based access to their CPAP usage for each 24 hours of treatment. They will be asked to view this data each day during the first week of the the study, and then as frequently as they choose after the first week. There will be a payment of $30 during the first week for each day a participant uses CPAP for more than 4 hours the previous night and logs on to the website.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Average daily hours of CPAP.
大体时间:3 months
Average daily hours of CPAP use determined objectively by the mask-on time recorded by the CPAP machine.
3 months
The change in the mean total score on the Functional Outcome of Sleep Questionnaire.
大体时间:3 months
The change in the mean total score on the Functional Outcome of Sleep Questionnaire (FOSQ-10), a validated, disease specific quality of life questionnaire.
3 months

次要结果测量

结果测量
措施说明
大体时间
The percentage of days that the CPAP apparatus was used and the average daily hours of CPAP use on days used.
大体时间:3 months
The percentage of days that the CPAP apparatus was used and the average daily hours of CPAP use on days used.
3 months
Total scores on the Epworth Sleepiness Scale (ESS) and the Medical Outcomes Study Short-Form-12 (SF-12).
大体时间:3 months
Total scores on the Epworth Sleepiness Scale (ESS) and the Medical Outcomes Study Short-Form-12 (SF-12).
3 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Samuel T Kuna, MD、University of Pennsylvania

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2011年9月1日

初级完成 (实际的)

2013年8月1日

研究完成 (实际的)

2013年8月1日

研究注册日期

首次提交

2011年4月13日

首先提交符合 QC 标准的

2011年4月13日

首次发布 (估计)

2011年4月14日

研究记录更新

最后更新发布 (估计)

2014年5月22日

上次提交的符合 QC 标准的更新

2014年5月20日

最后验证

2012年3月1日

更多信息

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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