Telemedici ne Management of Veterans With Newly Diagnosed Obstructiv e Sleep Apnea (OSA)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 2
- 主要终点
- Average daily hours of APAP use
研究概览
简要总结
Automatically titrating continuous positive airway pressure (APAP) and continuous positive airway pressure (CPAP) are considered first-line treatments for obstructive sleep apnea. There is a growing body of evidence that suggests that early patient education and intervention may improve adherence with positive airway pressure. The investigators plan a prospective, randomized trial to see if telemonitoring in the first several weeks of PAP therapy improves adherence following 3 months of treatment.
详细描述
Obstructive sleep apnea is a high-priority clinical condition for the Veterans Health Administration. With approximately 2% of middle-aged women and 4% of middle-aged men having OSA, the disorder places significant burden on the healthcare system. Obstructive sleep apnea (OSA) has been linked to major cardiovascular disorders such as coronary artery disease, congestive heart failure, hypertension, and stroke, as well as increased risk for motor vehicle crashes. Positive airway pressure (PAP) therapy is considered the treatment of choice for obstructive sleep apnea. However, adherence rates with CPAP and APAP therapy are disappointingly low. Veterans, especially those who are socioeconomically disadvantaged and those with psychiatric disease, demonstrate poor adherence when compared to the general population. Effective interventions are needed to improve adherence among patients diagnosed with OSA.
Currently, veterans diagnosed with OSA at the Philadelphia VA sleep center are treated with a home APAP machine that records their adherence on a smart card. They are scheduled for a follow-up appointment within one to three months after their initiation of APAP therapy to discuss questions and concerns regarding the machine as well as the mask and to download their adherence data. Given the limited availability of clinic appointments, some patients may have to wait longer than this.
More recently, APAP machines now distributed through the VA system offer the possibility of using wireless transmissions to track adherence data, including hours of use, mask leak, and apnea-hypopnea index (this transmission does not require hook up to the telephone and does not require the patient to have internet access). This offers the opportunity to see if remote monitoring within the first several weeks of APAP treatment improves adherence, and in turn, improves clinical response to treatment. At the present time, all patients enrolled at Philadelphia Veterans Administration Medical Center (PVAMC) who are newly diagnosed with OSA are being provided with APAP machines with modems that allow for wireless transmissions of data through the Phillips Respironics HIPPA compliant website, www.encoreanywhere.com. Review of the modem data is being performed on a limited basis in some patients. If remote monitoring improves adherence, the investigators may want to implement it for all APAP users. At present, the investigators do not know if this is a clinically effective or cost effective model for delivering health care.
The investigators will have a baseline chart review. It will include assessment of APAP settings (auto-titrate pressure ranges), model and size of mask interface, baseline sleep study results (mean AHI), and review of surveys now obtained as part of routine clinical care at the investigators sleep center, including: Epworth Sleepiness Scale (ESS) score, functional outcomes of sleep questionnaire (FOSQ) score, center for epidemiological studies of depression scale (CES-D score), short form health survey (SF-12), a health survey score and client satisfaction questionnaire (CSQ-8).
Sleep center staff will also perform a chart review to obtain demographic information (age, sex, race), BMI, daytime oxygen saturation (if available), and co-morbidities (congestive heart failure, diabetes, hypertension, obesity, chronic obstructive pulmonary disease (COPD), and depression or other psychological disorders) as part of their problem list in the computerized VA medical record. the investigators will use this chart review to compute a Charlson Morbidity Index.
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 90 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female veterans at least 18 years of age.
- •Ability to read and speak English (assessment instruments and therapy will be available only in English).
- •AHI> 5 on baseline home sleep study
- •Agree to initiate automatically titrating continuous positive airway pressure (APAP) therapy.
- •Completion of clinic questionnaires during initial sleep evaluation
排除标准
- •Unwilling to provide informed consent.
- •Lack of English fluency. This will be determined when potential subjects are contacted by phone. If they are able to understand the oral consent by correctly completing the mini-quiz, English fluency will be established.
- •No telephone access
- •Patients previously treated with positive airway pressure.
- •Patients enrolled in ongoing VA sleep research studies. Currently all patients enrolled in VA sleep research studies already have their charts flagged.
- •Patients receiving their sleep care at VA medical centers other than PVAMC, Fort Dix, Gloucester and Victor J. Saracini (Willow Grove).
- •Patients initiated on positive airway pressure treatment while in-patients will also be excluded.
- •Patients who are set up with APAP machines without modems will also be excluded.
结局指标
主要结局
Average daily hours of APAP use
时间窗: 90 days
Aim 1: The goal of this project is to determine whether telemedicine monitoring of APAP treatment in the first several weeks of treatment improves adherence following 3 months of treatment. Adherence will be measured objectively by the average daily hours of APAP use over 90 days.
次要结局
- Change in FOSQ-10 score(Change in baseline FOSQ-10 score to the FOSQ-10 score assessed at 90 days)
