激励增强 - 急性失代偿性心力衰竭和 OSA
出院后远程医疗动机增强干预对心力衰竭和阻塞性睡眠呼吸暂停的依从性和健康结果的影响
研究概览
详细说明
作为我们住院患者睡眠测试计划的一部分,高危 HF 患者接受由睡眠实验室技术人员设置的 III 型睡眠测试 (Nihon Kohden®)。 我们的住院患者睡眠服务还有一名临床护士,负责与患者一起进行 CPAP 呼吸机教育,设置并协助进行出院后睡眠护理。 如果需要滴定研究,一般安排在出院后 1-2 周。 所有住院患者的睡眠研究均由三位注册的多导睡眠图技术专家进行评分,我审查并完成这些研究(目前的临床流程作为领导住院服务的主要医生,将针对该临床试验进行扩充)。 研究协调员和我将接触那些 REI>5 且符合 Epic® 筛选资格的人,讨论睡眠研究结果,确认资格,邀请患者参与,如果有兴趣,将获得书面知情同意书。 同意书:同意书将以外行人的术语解释所有程序的性质。 将强调参与是自愿的。 研究协调员和 PI 将可以回答问题。 所有活动都将符合当地的 IRB 和 HIPPA 指南。
所有参与者都将在出院前获得由同一家庭护理健康提供的两家制造商(Philips Respironics ® 或 ResMed ®)提供的 Auto-CPAP。 PAP 压力将根据舒适度设置为 5-15 cmH2O、加热湿化和呼气压力释放。 调制解调器将连接到 PAP 设备以远程提取依从性数据(没有无线功能的 SD 卡)。 所有患者在出院前都将接受关于 PAP 治疗的标准化 20 分钟教育课程,我们的临床护士将建议他们每晚在睡眠期间使用他们的设备。 患者还将为佩戴面罩的家庭护理健康。 如果参与者有面具或压力不耐受问题,他们将直接向我们的研究协调员提供电话号码。 所有基线问卷将通过 REDcap 链接发送到患者的电子邮件或在出院前和访问期间以纸质形式完成(如果电子不可行,则为纸质)。 协调员将确保在出院前完成所有问卷,并指导患者完成后续问卷。 患者将以 1:1 的比例随机分配(REDCap 算法)接受 TIME 与标准护理。 块将是随机大小的,对研究调查人员不知情。 尽管让研究团队和参与者对干预措施视而不见是不可行的,但标准护理组也将接受睡眠卫生教育,以便对某种程度的干预措施有所了解,以尝试解决安慰剂效应。 在使用睡眠药物进行随访(TIME 组为 2 周和 2 个月,标准护理组为 2 个月)期间,前 15 分钟将重点关注 OSA 和解决两组问题,因为这是我们提供的标准临床护理睡眠障碍中心。 这 15 分钟之后,干预组将进行 30 分钟的 ME,对照组将进行 10 分钟的睡眠卫生教育。 两组的结果将在 3 个月和 6 个月时进行测量。 两组都将在 4 个月时接到一个加强电话。 干预组将接受 30 分钟的加强 ME 课程,而对照组将接受 10 分钟的睡眠卫生。
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名:Joan Aylor, BA
- 电话号码:216-445-1698
- 邮箱:aylorj@ccf.org
研究联系人备份
- 姓名:Cinthya Pena Orbea, MD
- 电话号码:216-445-1356
- 邮箱:penac@ccf.org
学习地点
-
-
Ohio
-
Cleveland、Ohio、美国、44195
- 招聘中
- Cleveland Clinic Foundation
-
接触:
- Joan Aylor, BA
- 电话号码:216-445-1698
- 邮箱:aylorj@ccf.org
-
接触:
- Cinthya Pena Orbea, MD
- 电话号码:216-445-1365
- 邮箱:penac@ccf.org
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
描述
纳入标准:
- 承认 ADHF 诊断
- OSA诊断(REI≥5)
- 未接受治疗且同意 PAP 治疗
- 同意参加。
排除标准:
- 先前或当前的 PAP 治疗
- 无法提供知情同意
- 中度缺氧(在室内空气中氧饱和度 < 87% 或在夜间睡眠研究期间需要 >2L O2
- 血液动力学不稳定(收缩压,SBP<90 mmHg,心率>120bpm)
- 中枢性呼吸暂停(中央呼吸暂停指数 > 呼吸暂停指数的 50%) 痴呆/认知功能障碍
- 无法参加视频电视访问。
学习计划
研究是如何设计的?
设计细节
- 主要用途:其他
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
无干预:提供者的护理标准
参与者将继续与提供者一起跟进睡眠呼吸暂停。
|
|
实验性的:远程医疗强化激励
参与者将参加远程医疗激励访问,以提高 PAP 依从性以及定期跟进睡眠呼吸暂停
|
参与者将参加远程医疗激励访问,以提高 PAP 依从性以及定期跟进睡眠呼吸暂停
其他名称:
|
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 |
---|---|---|
PAP 依从性(时间与护理标准)
大体时间:3个月
|
每晚平均每小时使用
|
3个月
|
PAP 依从性(时间与护理标准)
大体时间:6个月
|
每晚平均每小时使用
|
6个月
|
睡眠问卷的功能结果(时间与护理标准)
大体时间:2个月
|
睡眠问卷的功能结果 (FOSQ-10):子量表分数范围为 1-4(1= 极度困难,2= 中度困难,3= 有一点困难,4= 没有困难),总分范围为 5-20,较高分数表明更好的功能状态。
|
2个月
|
堪萨斯城心肌病问卷(时间与护理标准)
大体时间:2个月
|
堪萨斯城心肌病问卷 (KCCQ-12):身体限制、症状频率、生活质量和社会限制。
分数范围为 5-30,较高的基线 KCCQ-12 分数代表较好的健康状况
|
2个月
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
---|---|---|
TIME 与护理标准对 6 个月再入院率的影响
大体时间:6个月
|
6个月再入院
|
6个月
|
合作者和调查者
调查人员
- 首席研究员:Cinthya Pena Orbea, MD、The Cleveland Clinic
出版物和有用的链接
一般刊物
- Berry RB, Budhiraja R, Gottlieb DJ, Gozal D, Iber C, Kapur VK, Marcus CL, Mehra R, Parthasarathy S, Quan SF, Redline S, Strohl KP, Davidson Ward SL, Tangredi MM; American Academy of Sleep Medicine. Rules for scoring respiratory events in sleep: update of the 2007 AASM Manual for the Scoring of Sleep and Associated Events. Deliberations of the Sleep Apnea Definitions Task Force of the American Academy of Sleep Medicine. J Clin Sleep Med. 2012 Oct 15;8(5):597-619. doi: 10.5664/jcsm.2172.
- Ponikowski P, Voors AA, Anker SD, Bueno H, Cleland JGF, Coats AJS, Falk V, Gonzalez-Juanatey JR, Harjola VP, Jankowska EA, Jessup M, Linde C, Nihoyannopoulos P, Parissis JT, Pieske B, Riley JP, Rosano GMC, Ruilope LM, Ruschitzka F, Rutten FH, van der Meer P; ESC Scientific Document Group. 2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: The Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC)Developed with the special contribution of the Heart Failure Association (HFA) of the ESC. Eur Heart J. 2016 Jul 14;37(27):2129-2200. doi: 10.1093/eurheartj/ehw128. Epub 2016 May 20. No abstract available. Erratum In: Eur Heart J. 2016 Dec 30;:
- Virani SS, Alonso A, Benjamin EJ, Bittencourt MS, Callaway CW, Carson AP, Chamberlain AM, Chang AR, Cheng S, Delling FN, Djousse L, Elkind MSV, Ferguson JF, Fornage M, Khan SS, Kissela BM, Knutson KL, Kwan TW, Lackland DT, Lewis TT, Lichtman JH, Longenecker CT, Loop MS, Lutsey PL, Martin SS, Matsushita K, Moran AE, Mussolino ME, Perak AM, Rosamond WD, Roth GA, Sampson UKA, Satou GM, Schroeder EB, Shah SH, Shay CM, Spartano NL, Stokes A, Tirschwell DL, VanWagner LB, Tsao CW; American Heart Association Council on Epidemiology and Prevention Statistics Committee and Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2020 Update: A Report From the American Heart Association. Circulation. 2020 Mar 3;141(9):e139-e596. doi: 10.1161/CIR.0000000000000757. Epub 2020 Jan 29.
- Heidenreich PA, Albert NM, Allen LA, Bluemke DA, Butler J, Fonarow GC, Ikonomidis JS, Khavjou O, Konstam MA, Maddox TM, Nichol G, Pham M, Pina IL, Trogdon JG; American Heart Association Advocacy Coordinating Committee; Council on Arteriosclerosis, Thrombosis and Vascular Biology; Council on Cardiovascular Radiology and Intervention; Council on Clinical Cardiology; Council on Epidemiology and Prevention; Stroke Council. Forecasting the impact of heart failure in the United States: a policy statement from the American Heart Association. Circ Heart Fail. 2013 May;6(3):606-19. doi: 10.1161/HHF.0b013e318291329a. Epub 2013 Apr 24.
- Gottlieb DJ, Yenokyan G, Newman AB, O'Connor GT, Punjabi NM, Quan SF, Redline S, Resnick HE, Tong EK, Diener-West M, Shahar E. Prospective study of obstructive sleep apnea and incident coronary heart disease and heart failure: the sleep heart health study. Circulation. 2010 Jul 27;122(4):352-60. doi: 10.1161/CIRCULATIONAHA.109.901801. Epub 2010 Jul 12.
- Amir O, Ben-Gal T, Weinstein JM, Schliamser J, Burkhoff D, Abbo A, Abraham WT. Evaluation of remote dielectric sensing (ReDS) technology-guided therapy for decreasing heart failure re-hospitalizations. Int J Cardiol. 2017 Aug 1;240:279-284. doi: 10.1016/j.ijcard.2017.02.120. Epub 2017 Mar 3.
- Chasens ER, Ratcliffe SJ, Weaver TE. Development of the FOSQ-10: a short version of the Functional Outcomes of Sleep Questionnaire. Sleep. 2009 Jul;32(7):915-9. doi: 10.1093/sleep/32.7.915.
- Koehler F, Koehler K, Deckwart O, Prescher S, Wegscheider K, Kirwan BA, Winkler S, Vettorazzi E, Bruch L, Oeff M, Zugck C, Doerr G, Naegele H, Stork S, Butter C, Sechtem U, Angermann C, Gola G, Prondzinsky R, Edelmann F, Spethmann S, Schellong SM, Schulze PC, Bauersachs J, Wellge B, Schoebel C, Tajsic M, Dreger H, Anker SD, Stangl K. Efficacy of telemedical interventional management in patients with heart failure (TIM-HF2): a randomised, controlled, parallel-group, unmasked trial. Lancet. 2018 Sep 22;392(10152):1047-1057. doi: 10.1016/S0140-6736(18)31880-4. Epub 2018 Aug 25.
- Fox N, Hirsch-Allen AJ, Goodfellow E, Wenner J, Fleetham J, Ryan CF, Kwiatkowska M, Ayas NT. The impact of a telemedicine monitoring system on positive airway pressure adherence in patients with obstructive sleep apnea: a randomized controlled trial. Sleep. 2012 Apr 1;35(4):477-81. doi: 10.5665/sleep.1728.
- Aloia MS, Arnedt JT, Riggs RL, Hecht J, Borrelli B. Clinical management of poor adherence to CPAP: motivational enhancement. Behav Sleep Med. 2004;2(4):205-22. doi: 10.1207/s15402010bsm0204_3.
- Spertus JA, Jones PG. Development and Validation of a Short Version of the Kansas City Cardiomyopathy Questionnaire. Circ Cardiovasc Qual Outcomes. 2015 Sep;8(5):469-76. doi: 10.1161/CIRCOUTCOMES.115.001958.
- Arzt M, Young T, Finn L, Skatrud JB, Ryan CM, Newton GE, Mak S, Parker JD, Floras JS, Bradley TD. Sleepiness and sleep in patients with both systolic heart failure and obstructive sleep apnea. Arch Intern Med. 2006 Sep 18;166(16):1716-22. doi: 10.1001/archinte.166.16.1716.
- Bakker JP, Weaver TE, Parthasarathy S, Aloia MS. Adherence to CPAP: What Should We Be Aiming For, and How Can We Get There? Chest. 2019 Jun;155(6):1272-1287. doi: 10.1016/j.chest.2019.01.012. Epub 2019 Jan 23.
- Bakker JP, Wang R, Weng J, Aloia MS, Toth C, Morrical MG, Gleason KJ, Rueschman M, Dorsey C, Patel SR, Ware JH, Mittleman MA, Redline S. Motivational Enhancement for Increasing Adherence to CPAP: A Randomized Controlled Trial. Chest. 2016 Aug;150(2):337-45. doi: 10.1016/j.chest.2016.03.019. Epub 2016 Mar 24.
- MacDonald M, Fang J, Pittman SD, White DP, Malhotra A. The current prevalence of sleep disordered breathing in congestive heart failure patients treated with beta-blockers. J Clin Sleep Med. 2008 Feb 15;4(1):38-42.
- Khayat R, Small R, Rathman L, Krueger S, Gocke B, Clark L, Yamokoski L, Abraham WT. Sleep-disordered breathing in heart failure: identifying and treating an important but often unrecognized comorbidity in heart failure patients. J Card Fail. 2013 Jun;19(6):431-44. doi: 10.1016/j.cardfail.2013.04.005.
- Khayat RN, Jarjoura D, Patt B, Yamokoski T, Abraham WT. In-hospital testing for sleep-disordered breathing in hospitalized patients with decompensated heart failure: report of prevalence and patient characteristics. J Card Fail. 2009 Nov;15(9):739-46. doi: 10.1016/j.cardfail.2009.05.005. Epub 2009 Jun 26.
- Khattak HK, Hayat F, Pamboukian SV, Hahn HS, Schwartz BP, Stein PK. Obstructive Sleep Apnea in Heart Failure: Review of Prevalence, Treatment with Continuous Positive Airway Pressure, and Prognosis. Tex Heart Inst J. 2018 Jun 1;45(3):151-161. doi: 10.14503/THIJ-15-5678. eCollection 2018 Jun.
- Khayat R, Jarjoura D, Porter K, Sow A, Wannemacher J, Dohar R, Pleister A, Abraham WT. Sleep disordered breathing and post-discharge mortality in patients with acute heart failure. Eur Heart J. 2015 Jun 14;36(23):1463-9. doi: 10.1093/eurheartj/ehu522. Epub 2015 Jan 29.
- Isetta V, Leon C, Torres M, Embid C, Roca J, Navajas D, Farre R, Montserrat JM. Telemedicine-based approach for obstructive sleep apnea management: building evidence. Interact J Med Res. 2014 Feb 19;3(1):e6. doi: 10.2196/ijmr.3060.
- Hoy CJ, Vennelle M, Kingshott RN, Engleman HM, Douglas NJ. Can intensive support improve continuous positive airway pressure use in patients with the sleep apnea/hypopnea syndrome? Am J Respir Crit Care Med. 1999 Apr;159(4 Pt 1):1096-100. doi: 10.1164/ajrccm.159.4.9808008.
- Kitsiou S, Pare G, Jaana M. Effects of home telemonitoring interventions on patients with chronic heart failure: an overview of systematic reviews. J Med Internet Res. 2015 Mar 12;17(3):e63. doi: 10.2196/jmir.4174.
- Van Ryswyk E, Anderson CS, Antic NA, Barbe F, Bittencourt L, Freed R, Heeley E, Liu Z, Loffler KA, Lorenzi-Filho G, Luo Y, Margalef MJM, McEvoy RD, Mediano O, Mukherjee S, Ou Q, Woodman R, Zhang X, Chai-Coetzer CL. Predictors of long-term adherence to continuous positive airway pressure in patients with obstructive sleep apnea and cardiovascular disease. Sleep. 2019 Oct 9;42(10):zsz152. doi: 10.1093/sleep/zsz152.
- Smith CE, Dauz ER, Clements F, Puno FN, Cook D, Doolittle G, Leeds W. Telehealth services to improve nonadherence: A placebo-controlled study. Telemed J E Health. 2006 Jun;12(3):289-96. doi: 10.1089/tmj.2006.12.289.
- Rohr R. Rehospitalizations among patients in the Medicare fee-for-service program. N Engl J Med. 2009 Jul 16;361(3):311-2; author reply 312. No abstract available.
- Joynt KE, Jha AK. Who has higher readmission rates for heart failure, and why? Implications for efforts to improve care using financial incentives. Circ Cardiovasc Qual Outcomes. 2011 Jan 1;4(1):53-9. doi: 10.1161/CIRCOUTCOMES.110.950964. Epub 2010 Dec 14.
- Athilingam P, Jenkins BA, Zumpano H, Labrador MA. "Mobile technology to improve heart failure outcomes: A proof of concept paper". Appl Nurs Res. 2018 Feb;39:26-33. doi: 10.1016/j.apnr.2017.10.018. Epub 2017 Oct 19.
- McAlister FA, Youngson E, Kaul P, Ezekowitz JA. Early Follow-Up After a Heart Failure Exacerbation: The Importance of Continuity. Circ Heart Fail. 2016 Sep;9(9):e003194. doi: 10.1161/CIRCHEARTFAILURE.116.003194.
- Wang H, Parker JD, Newton GE, Floras JS, Mak S, Chiu KL, Ruttanaumpawan P, Tomlinson G, Bradley TD. Influence of obstructive sleep apnea on mortality in patients with heart failure. J Am Coll Cardiol. 2007 Apr 17;49(15):1625-1631. doi: 10.1016/j.jacc.2006.12.046. Epub 2007 Apr 2.
- Sharma S, Chakraborty A, Chowdhury A, Mukhtar U, Willes L, Quan SF. Adherence to Positive Airway Pressure Therapy in Hospitalized Patients with Decompensated Heart Failure and Sleep-Disordered Breathing. J Clin Sleep Med. 2016 Dec 15;12(12):1615-1621. doi: 10.5664/jcsm.6344.
- Kauta SR, Keenan BT, Goldberg L, Schwab RJ. Diagnosis and treatment of sleep disordered breathing in hospitalized cardiac patients: a reduction in 30-day hospital readmission rates. J Clin Sleep Med. 2014 Oct 15;10(10):1051-9. doi: 10.5664/jcsm.4096.
- Isetta V, Negrin MA, Monasterio C, Masa JF, Feu N, Alvarez A, Campos-Rodriguez F, Ruiz C, Abad J, Vazquez-Polo FJ, Farre R, Galdeano M, Lloberes P, Embid C, de la Pena M, Puertas J, Dalmases M, Salord N, Corral J, Jurado B, Leon C, Egea C, Munoz A, Parra O, Cambrodi R, Martel-Escobar M, Arque M, Montserrat JM; SPANISH SLEEP NETWORK. A Bayesian cost-effectiveness analysis of a telemedicine-based strategy for the management of sleep apnoea: a multicentre randomised controlled trial. Thorax. 2015 Nov;70(11):1054-61. doi: 10.1136/thoraxjnl-2015-207032. Epub 2015 Aug 26.
- Aloia MS, Arnedt JT, Stepnowsky C, Hecht J, Borrelli B. Predicting treatment adherence in obstructive sleep apnea using principles of behavior change. J Clin Sleep Med. 2005 Oct 15;1(4):346-53.
- Stepnowsky CJ Jr, Marler MR, Ancoli-Israel S. Determinants of nasal CPAP compliance. Sleep Med. 2002 May;3(3):239-47. doi: 10.1016/s1389-9457(01)00162-9.
- Olsen S, Smith SS, Oei TP, Douglas J. Motivational interviewing (MINT) improves continuous positive airway pressure (CPAP) acceptance and adherence: a randomized controlled trial. J Consult Clin Psychol. 2012 Feb;80(1):151-63. doi: 10.1037/a0026302. Epub 2011 Nov 21.
- Lai AYK, Fong DYT, Lam JCM, Weaver TE, Ip MSM. The efficacy of a brief motivational enhancement education program on CPAP adherence in OSA: a randomized controlled trial. Chest. 2014 Sep;146(3):600-610. doi: 10.1378/chest.13-2228.
- Kahwash R, Khayat RN. A Practical Approach to the Identification and Management of Sleep-Disordered Breathing in Heart Failure Patients. Sleep Med Clin. 2017 Jun;12(2):205-219. doi: 10.1016/j.jsmc.2017.01.002. Epub 2017 Mar 9.
- Collop NA, Tracy SL, Kapur V, Mehra R, Kuhlmann D, Fleishman SA, Ojile JM. Obstructive sleep apnea devices for out-of-center (OOC) testing: technology evaluation. J Clin Sleep Med. 2011 Oct 15;7(5):531-48. doi: 10.5664/JCSM.1328.
- Aloia MS, Arnedt JT, Strand M, Millman RP, Borrelli B. Motivational enhancement to improve adherence to positive airway pressure in patients with obstructive sleep apnea: a randomized controlled trial. Sleep. 2013 Nov 1;36(11):1655-62. doi: 10.5665/sleep.3120.
- Weaver TE , Crosby RD , Bron M , Menno D MS. Using Multiple Anchor-based And Distribution-based Estimates To Determine The Minimal Important Difference (MID) For The FOSQ-10. Sleep. 2018;41(Mid):292-293.
- WR, Miller, Rollnick S. Motivational Interviewing: Preparing People for Change. 2nd ed. New York: Guildford Press; 2002.
- Pena Orbea C, St Louis E, Dupuy-McCauley K, F Shaughnessy G, I Morgenthaler T. 0495 Sleep Medicine and the Hospitalized Patient: Evaluation and Predictors for Sleep Disordered Breathing Testing and Associated Outcomes. Vol 42.; 2019. doi:10.1093/sleep/zsz067.493
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
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.