Motivational Enhancement - Acute Decompensated Heart Failure and OSA

NCT04752462 | Completed

• 1 other identifier: 21-075
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

A feasibility randomized controlled trial will be conducted with a 6-month follow up to: Examine the impact of early intensive telemedicine motivational enhancement (TIME) vs standard of care on PAP adherence (n=40/group) and continuity of care at 3 and 6 months post-discharge in patients admitted with ADHF with a new inpatient diagnosis of OSA(REI\>5). Assess the effect of early telemedicine integrated with motivational enhancement (TIME) vs standard of care on patient reported outcomes including Functional Outcomes of Sleep questionnaire (FOSQ-10), Kansas City Cardiomyopathy Questionnaire (KCCQ-12). Investigate the impact of early TIME vs standard of care on 6-month hospital readmissions.

Conditions

Acute Decompensated Heart Failure; Obstructive Sleep Apnea; Motivational Enhancement; PAP Adherence

Outcome Measures

Primary Outcomes (4)

• PAP Adherence (TIME versus Standard of Care)

  average hourly use per night

  3 Month

• PAP Adherence (TIME versus Standard of Care)

  average hourly use per night

  6 Month

• Functional Outcomes of Sleep Questionnaire (TIME versus Standard of Care)

  Functional Outcomes of Sleep Questionnaire (FOSQ-10): Subscale scores range from 1-4 (1= extreme difficulty, 2= moderate difficulty, 3= a little difficulty, 4= no difficulty) with total scores ranging from 5-20 with higher scores indicating better functional status.

  2 Months

• Kansas City Cardiomyopathy Questionnaire (TIME versus Standard of Care)

  Kansas City Cardiomyopathy Questionnaire (KCCQ-12):: physical limitation, symptom frequency, quality of life, and social limitation. Scores ranges from 5-30, higher KCCQ-12 scores from baseline represent better health status

  2 Months

Other Outcomes (1)

• Impact of TIME vs Standard of Care on 6-month hospital readmissions

  6 Month

Study Arms (2)

Standard of Care with provider

NO INTERVENTION

Participant will continue follow up for sleep apnea with provider.

Telemedicine Intensive Motivational Enhancement

EXPERIMENTAL

Participants will attend a telemedicine motivational enhancement visit to improve PAP adherence along with regular follow up for sleep apnea

Behavioral: Telemedicine Intensive Motivational Enhancement

Interventions

Telemedicine Intensive Motivational Enhancement BEHAVIORAL

Participants will attend a telemedicine motivational enhancement visit to improve PAP adherence along with regular follow up for sleep apnea

Also known as: TIME

Telemedicine Intensive Motivational Enhancement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Admitting ADHF diagnosis
• OSA diagnosis (REI ≥5)
• Treatment-naive and agreeable to PAP therapy
• Agrees to participate.

You may not qualify if:

• Prior or current PAP therapy
• Unable to provide informed consent
• Moderately hypoxic (oxygen saturation \< 87% on room air or requiring \>2L of O2 during overnight sleep study
• Hemodynamically unstable (systolic blood pressure, SBP\<90 mmHg, heart rate\>120bpm)
• Central predominant apnea (Central Apnea Index \> 50% of the Apnea Index) Dementia/cognitive dysfunction
• Unable to participant in video televisits.

Sponsors & Collaborators

• The Cleveland Clinic: lead
• American Academy of Sleep Medicine: collaborator

Study Sites (1)

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Related Publications (42)

• 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.

  PMID: 31992061 BACKGROUND

• 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.

  PMID: 23616602 BACKGROUND

• 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.

  PMID: 23743494 BACKGROUND

• 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.

  PMID: 19879459 BACKGROUND

• 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.

  PMID: 30072851 BACKGROUND

• 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.

  PMID: 25636743 BACKGROUND

• 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.

  PMID: 22467985 BACKGROUND

• 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.

  PMID: 24554392 BACKGROUND

• 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.

  PMID: 10194151 BACKGROUND

• 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.

  PMID: 25768664 BACKGROUND

• 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.

  PMID: 31587046 BACKGROUND

• 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.

  PMID: 30684472 BACKGROUND

• 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.

  PMID: 27018174 BACKGROUND

• 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.

  PMID: 16796496 BACKGROUND

• 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.

  PMID: 19610166 BACKGROUND

• 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.

  PMID: 21156879 BACKGROUND

• 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.

  PMID: 28341372 BACKGROUND

• 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.

  PMID: 29422170 BACKGROUND

• 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.

  PMID: 27618853 BACKGROUND

• 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.

  PMID: 18350960 BACKGROUND

• 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.

  PMID: 20625114 BACKGROUND

• 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.

  PMID: 17433953 BACKGROUND

• 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.

  PMID: 27568891 BACKGROUND

• 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.

  PMID: 25317084 BACKGROUND

• 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.

  PMID: 26310452 BACKGROUND

• 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.

  PMID: 30153985 BACKGROUND

• 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.

  PMID: 17564399 BACKGROUND

• 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.

  PMID: 14592213 BACKGROUND

• 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.

  PMID: 22103957 BACKGROUND

• 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.

  PMID: 24810282 BACKGROUND

• 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.

  PMID: 16983049 BACKGROUND

• 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.

  PMID: 28477775 BACKGROUND

• 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.

  PMID: 27206819 BACKGROUND

• 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.

  PMID: 23066376 BACKGROUND

• 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.

  PMID: 22003351 BACKGROUND

• 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.

  PMID: 15600056 BACKGROUND

• 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.

  PMID: 19639754 BACKGROUND

• 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.

  PMID: 26307129 BACKGROUND

• 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.

  PMID: 24179298 BACKGROUND

• 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.

  BACKGROUND

• WR, Miller, Rollnick S. Motivational Interviewing: Preparing People for Change. 2nd ed. New York: Guildford Press; 2002.

  BACKGROUND

• 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

  BACKGROUND

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Time

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Physical Phenomena

Study Officials

• Cinthya Pena Orbea, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 9, 2021
• First Posted: February 12, 2021
• Study Start: May 13, 2021
• Primary Completion: January 31, 2025
• Study Completion: January 31, 2025
• Last Updated: July 9, 2025

Record last verified: 2025-07

Locations

US (1)