ODYSSEE Kidney Health Trial

NCT06274710 | Recruiting DMC

• 1 other identifier: 23-5554
• Study Type: interventional
• Target: 344
• Locations: 1 country
• Sites: 1

Brief Summary

INTRODUCTION Severe CKD is defined as a risk of greater than 10% for progressing to RRT \[home hemodialysis (HHD), home peritoneal dialysis (HPD), and transplantation\] within 2 years. There is a need to improve access to CKD self-care counselling and RRT education for patients with severe CKD. Trials of CKD self-care education have achieved therapeutic benefits with moderate to high patient-provider contact. There is high potential for a trial of digital counselling for CKD self-care and RRT education to enhance patient health and quality of life. HYPOTHESES The primary hypothesis is that ODYSSEE-KH versus usual care (UC) will significantly increase the incidence of home RRT, measured by a composite index of HHD, HPD, and preemptive kidney transplant at trial completion (median = 19 months; range: 12 to 27 months). The secondary hypothesis is that ODYSSEE-KH for CKD self-care and RRT education improves Home RRT, RRT preparation, annual hospitalization rate, engagement with CKD self-care resources at months 6 and 12 and trial completion and scores on outcome measures. RECRUITMENT Patients diagnosed with CKD who are 18 years of age or older were recruited from University Health Network (UHN), Sunnybrook Hospital, Scarborough Health Network, and The Ottawa Hospital. DESIGN ODYSSEE-KH is a double-arm, parallel-group, randomized controlled trial that has assessments at baseline, months 6 and 12, and trial completion (median = 19 months; range: 12 to 27 months). This is a single-blind design with research personnel masked. ODYSSEE-KH combines automated digital counselling of CKD self-care with renal replacement therapy (RRT) education. UC enhances the standard of usual care by providing patients with conventional digital CKD education. Over 27 months, patients will be emailed on a weekly basis with a digital link to log on to their respective program using a password-protected, personal account. ANALYSIS Separate GLMs will evaluate if Digital Counselling versus UC is independently associated with outcomes at months 6 and 12 and trial completion (median = 19; range: 12 to 27 months). Dependent variables include the KDQOL-SF, SF-36, EUROIA, PHQ-9, GAD-7, MIDLS, ESSI, PWB, BMPN, AI, as well as a modified SEMCD-6. Multivariable models will adjust for baseline assessments of each outcome and potential baseline covariates (noted above). In all GLMs, significant interactions will be followed by subgroup analyses with Bonferroni post hoc tests.

Conditions

Chronic Kidney Diseases

Keywords

Cognitive behavioural therapy; Motivational interviewing; eHealth; Self-care behaviours; Clinical Trial; Health-related quality of life; Digital health; Digital counselling; Clinical outcomes

Outcome Measures

Primary Outcomes (1)

• Incidence of home RRT

  The primary objective is to determine whether an automated digital counselling program for CKD self-care and RRT education improves RRT or preemptive renal transplant over a median of 19 months. As in our previous research,45-47 assessment of RRT includes documentation of incident home dialysis (HPD or HHD) or preemptive kidney transplant (before dialysis) in a composite index, using data from the Canadian Institute for Health Information (CIHI).48

  Trial completion (median = 19 months, range = 12-27 months)

Secondary Outcomes (18)

• Improvement of Home RRT

  Month 6, month 12, Trial completion (median = 19 months, range = 12-27 months)

• Improvement of RRT preparation with planned dialysis access

  Month 6, month 12, Trial completion (median = 19 months, range = 12-27 months)

• Incidence of annual hospitalization rate

  Month 6, month 12, Trial completion (median = 19 months, range = 12-27 months)

• Engagement with RRT education and CKD self-care counselling resources

  Month 6, month 12, Trial completion (median = 19 months, range = 12-27 months)

• Self-reported engagement in activities for living well

  Month 6, month 12, Trial completion (median = 19 months, range = 12-27 months)

Study Arms (2)

ODYSSEE-KH

EXPERIMENTAL

Participants in the intervention arm of the trial will have full access to digital counselling materials for CKD self-care and RRT education. Program engagement is dynamic with videos, digital handouts, animated charts, infographics, interactive digital trackers, and self-assessment forms. Patients will receive weekly email links to digital sessions (Supplements 1 and 2). Initial sessions will build motivation for therapeutic change. Subsequent sessions follow CBT guidelines. Finally, a monthly video posted on ODYSSEE will address common challenges and patient comments or queries.

Behavioral: ODYSSEE-KH

Usual care (UC)

NO INTERVENTION

UC is the standard of usual care which provides patients with conventional digital CKD education

Interventions

ODYSSEE-KH BEHAVIORAL

Automated digital counselling program

ODYSSEE-KH

Eligibility Criteria

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

You may qualify if:

• CKD patients who are at least 18 years old, that have a greater than a 10% risk of requiring dialysis within 2 years, using the 4-variable 2-year Kidney Failure Risk Equation,1,2 and are registered in a nephrology clinic (including an in-center dialysis clinic) at a participating hospital
• Confirmation from a referring nephrologist that the CKD has been stable for at least 1 month at the time of enrollment
• Oral and written comprehension of English or French
• Informed written consent
• At least a basic level of self-reported computer literacy
• Access to the internet and a computer

You may not qualify if:

• Previous kidney transplant or waitlisted for organ transplant at the time of enrollment
• Severe co-morbidities that prohibit full participation (e.g., dementia, clinically severe depression)
• Diagnosis of a medical condition for which the life expectancy is less than 2 years.

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Sunnybrook Health Sciences Centre: collaborator
• Scarborough General Hospital: collaborator
• The Ottawa Hospital: collaborator

Study Sites (1)

University Health Network

Toronto, Ontario, M2N 7A2, Canada

RECRUITING

Related Publications (75)

• Tangri N, Stevens LA, Griffith J, Tighiouart H, Djurdjev O, Naimark D, Levin A, Levey AS. A predictive model for progression of chronic kidney disease to kidney failure. JAMA. 2011 Apr 20;305(15):1553-9. doi: 10.1001/jama.2011.451. Epub 2011 Apr 11.

  PMID: 21482743 BACKGROUND

• Tangri N, Grams ME, Levey AS, Coresh J, Appel LJ, Astor BC, Chodick G, Collins AJ, Djurdjev O, Elley CR, Evans M, Garg AX, Hallan SI, Inker LA, Ito S, Jee SH, Kovesdy CP, Kronenberg F, Heerspink HJ, Marks A, Nadkarni GN, Navaneethan SD, Nelson RG, Titze S, Sarnak MJ, Stengel B, Woodward M, Iseki K; CKD Prognosis Consortium. Multinational Assessment of Accuracy of Equations for Predicting Risk of Kidney Failure: A Meta-analysis. JAMA. 2016 Jan 12;315(2):164-74. doi: 10.1001/jama.2015.18202.

  PMID: 26757465 BACKGROUND

• Bello AK, Ronksley PE, Tangri N, Kurzawa J, Osman MA, Singer A, Grill A, Nitsch D, Queenan JA, Wick J, Lindeman C, Soos B, Tuot DS, Shojai S, Brimble S, Mangin D, Drummond N. Prevalence and Demographics of CKD in Canadian Primary Care Practices: A Cross-sectional Study. Kidney Int Rep. 2019 Jan 21;4(4):561-570. doi: 10.1016/j.ekir.2019.01.005. eCollection 2019 Apr.

  PMID: 30993231 BACKGROUND

• Manns B, Hemmelgarn B, Tonelli M, Au F, So H, Weaver R, Quinn AE, Klarenbach S; for Canadians Seeking Solutions and Innovations to Overcome Chronic Kidney Disease. The Cost of Care for People With Chronic Kidney Disease. Can J Kidney Health Dis. 2019 Apr 4;6:2054358119835521. doi: 10.1177/2054358119835521. eCollection 2019.

  PMID: 31057803 BACKGROUND

• Inker LA, Astor BC, Fox CH, Isakova T, Lash JP, Peralta CA, Kurella Tamura M, Feldman HI. KDOQI US commentary on the 2012 KDIGO clinical practice guideline for the evaluation and management of CKD. Am J Kidney Dis. 2014 May;63(5):713-35. doi: 10.1053/j.ajkd.2014.01.416. Epub 2014 Mar 16.

  PMID: 24647050 BACKGROUND

• Gorodetskaya I, Zenios S, McCulloch CE, Bostrom A, Hsu CY, Bindman AB, Go AS, Chertow GM. Health-related quality of life and estimates of utility in chronic kidney disease. Kidney Int. 2005 Dec;68(6):2801-8. doi: 10.1111/j.1523-1755.2005.00752.x.

  PMID: 16316356 BACKGROUND

• Landreneau K, Lee K, Landreneau MD. Quality of life in patients undergoing hemodialysis and renal transplantation--a meta-analytic review. Nephrol Nurs J. 2010 Jan-Feb;37(1):37-44.

  PMID: 20333902 BACKGROUND

• Vinson AJ, Perl J, Tennankore KK. Survival Comparisons of Home Dialysis Versus In-Center Hemodialysis: A Narrative Review. Can J Kidney Health Dis. 2019 Jul 13;6:2054358119861941. doi: 10.1177/2054358119861941. eCollection 2019.

  PMID: 31321065 BACKGROUND

• Eneanya ND, Maddux DW, Reviriego-Mendoza MM, Larkin JW, Usvyat LA, van der Sande FM, Kooman JP, Maddux FW. Longitudinal patterns of health-related quality of life and dialysis modality: a national cohort study. BMC Nephrol. 2019 Jan 8;20(1):7. doi: 10.1186/s12882-018-1198-5.

  PMID: 30621634 BACKGROUND

• Klarenbach S, Tonelli M, Pauly R, Walsh M, Culleton B, So H, Hemmelgarn B, Manns B. Economic evaluation of frequent home nocturnal hemodialysis based on a randomized controlled trial. J Am Soc Nephrol. 2014 Mar;25(3):587-94. doi: 10.1681/ASN.2013040360. Epub 2013 Nov 14.

  PMID: 24231665 BACKGROUND

• Chan CT, Wallace E, Golper TA, Rosner MH, Seshasai RK, Glickman JD, Schreiber M, Gee P, Rocco MV. Exploring Barriers and Potential Solutions in Home Dialysis: An NKF-KDOQI Conference Outcomes Report. Am J Kidney Dis. 2019 Mar;73(3):363-371. doi: 10.1053/j.ajkd.2018.09.015. Epub 2018 Dec 10.

  PMID: 30545707 BACKGROUND

• Dahlerus C, Quinn M, Messersmith E, Lachance L, Subramanian L, Perry E, Cole J, Zhao J, Lee C, McCall M, Paulson L, Tentori F. Patient Perspectives on the Choice of Dialysis Modality: Results From the Empowering Patients on Choices for Renal Replacement Therapy (EPOCH-RRT) Study. Am J Kidney Dis. 2016 Dec;68(6):901-910. doi: 10.1053/j.ajkd.2016.05.010. Epub 2016 Jun 21.

  PMID: 27337991 BACKGROUND

• Akbari A, Clase CM, Acott P, Battistella M, Bello A, Feltmate P, Grill A, Karsanji M, Komenda P, Madore F, Manns BJ, Mahdavi S, Mustafa RA, Smyth A, Welcher ES. Canadian Society of Nephrology commentary on the KDIGO clinical practice guideline for CKD evaluation and management. Am J Kidney Dis. 2015 Feb;65(2):177-205. doi: 10.1053/j.ajkd.2014.10.013. Epub 2014 Nov 4.

  PMID: 25511161 BACKGROUND

• Smart NA, Dieberg G, Ladhani M, Titus T. Early referral to specialist nephrology services for preventing the progression to end-stage kidney disease. Cochrane Database Syst Rev. 2014 Jun 18;(6):CD007333. doi: 10.1002/14651858.CD007333.pub2.

  PMID: 24938824 BACKGROUND

• He T, Liu X, Li Y, Wu Q, Liu M, Yuan H. Remote home management for chronic kidney disease: A systematic review. J Telemed Telecare. 2017 Jan;23(1):3-13. doi: 10.1177/1357633X15626855. Epub 2016 Jul 9.

  PMID: 27269795 BACKGROUND

• Fishbane S, Agoritsas S, Bellucci A, Halinski C, Shah HH, Sakhiya V, Balsam L. Augmented Nurse Care Management in CKD Stages 4 to 5: A Randomized Trial. Am J Kidney Dis. 2017 Oct;70(4):498-505. doi: 10.1053/j.ajkd.2017.02.366. Epub 2017 Apr 7.

  PMID: 28396108 BACKGROUND

• Lin MY, Liu MF, Hsu LF, Tsai PS. Effects of self-management on chronic kidney disease: A meta-analysis. Int J Nurs Stud. 2017 Sep;74:128-137. doi: 10.1016/j.ijnurstu.2017.06.008. Epub 2017 Jun 21.

  PMID: 28689160 BACKGROUND

• Fadem SZ, Walker DR, Abbott G, Friedman AL, Goldman R, Sexton S, Buettner K, Robinson K, Peters TG. Satisfaction with renal replacement therapy and education: the American Association of Kidney Patients survey. Clin J Am Soc Nephrol. 2011 Mar;6(3):605-12. doi: 10.2215/CJN.06970810. Epub 2011 Feb 17.

  PMID: 21330485 BACKGROUND

• Walker RC, Hanson CS, Palmer SC, Howard K, Morton RL, Marshall MR, Tong A. Patient and caregiver perspectives on home hemodialysis: a systematic review. Am J Kidney Dis. 2015 Mar;65(3):451-63. doi: 10.1053/j.ajkd.2014.10.020. Epub 2015 Jan 10.

  PMID: 25582285 BACKGROUND

• Khaw KT, Wareham N, Bingham S, Welch A, Luben R, Day N. Combined impact of health behaviours and mortality in men and women: the EPIC-Norfolk prospective population study. PLoS Med. 2008 Jan 8;5(1):e12. doi: 10.1371/journal.pmed.0050012.

  PMID: 18184033 BACKGROUND

• Simpson SH, Eurich DT, Majumdar SR, Padwal RS, Tsuyuki RT, Varney J, Johnson JA. A meta-analysis of the association between adherence to drug therapy and mortality. BMJ. 2006 Jul 1;333(7557):15. doi: 10.1136/bmj.38875.675486.55. Epub 2006 Jun 21.

  PMID: 16790458 BACKGROUND

• Kummervold PE, Chronaki CE, Lausen B, Prokosch HU, Rasmussen J, Santana S, Staniszewski A, Wangberg SC. eHealth trends in Europe 2005-2007: a population-based survey. J Med Internet Res. 2008 Nov 17;10(4):e42. doi: 10.2196/jmir.1023.

  PMID: 19017584 BACKGROUND

• Milazi M, Bonner A, Douglas C. Effectiveness of educational or behavioral interventions on adherence to phosphate control in adults receiving hemodialysis: a systematic review. JBI Database System Rev Implement Rep. 2017 Apr;15(4):971-1010. doi: 10.11124/JBISRIR-2017-003360.

  PMID: 28398983 BACKGROUND

• Hung CS, Lee J, Chen YH, Huang CC, Wu VC, Wu HW, Chuang PY, Ho YL. Effect of Contract Compliance Rate to a Fourth-Generation Telehealth Program on the Risk of Hospitalization in Patients With Chronic Kidney Disease: Retrospective Cohort Study. J Med Internet Res. 2018 Jan 24;20(1):e23. doi: 10.2196/jmir.8914.

  PMID: 29367185 BACKGROUND

• Beishuizen CR, Stephan BC, van Gool WA, Brayne C, Peters RJ, Andrieu S, Kivipelto M, Soininen H, Busschers WB, Moll van Charante EP, Richard E. Web-Based Interventions Targeting Cardiovascular Risk Factors in Middle-Aged and Older People: A Systematic Review and Meta-Analysis. J Med Internet Res. 2016 Mar 11;18(3):e55. doi: 10.2196/jmir.5218.

  PMID: 26968879 BACKGROUND

• Garcia-Lizana F, Sarria-Santamera A. New technologies for chronic disease management and control: a systematic review. J Telemed Telecare. 2007;13(2):62-8. doi: 10.1258/135763307780096140.

  PMID: 17359568 BACKGROUND

• Comellas M, Walker EA, Movsas S, Merkin S, Zonszein J, Strelnick H. Training community health promoters to implement diabetes self-management support programs for urban minority adults. Diabetes Educ. 2010 Jan-Feb;36(1):141-51. doi: 10.1177/0145721709354606. Epub 2009 Dec 4.

  PMID: 19966071 BACKGROUND

• Clark AM, Hartling L, Vandermeer B, McAlister FA. Meta-analysis: secondary prevention programs for patients with coronary artery disease. Ann Intern Med. 2005 Nov 1;143(9):659-72. doi: 10.7326/0003-4819-143-9-200511010-00010.

  PMID: 16263889 BACKGROUND

• Hunting G, Shahid N, Sahakyan Y, Fan I, Moneypenny CR, Stanimirovic A, North T, Petrosyan Y, Krahn MD, Rac VE. A multi-level qualitative analysis of Telehomecare in Ontario: challenges and opportunities. BMC Health Serv Res. 2015 Dec 9;15:544. doi: 10.1186/s12913-015-1196-2.

  PMID: 26645639 BACKGROUND

• Pechlivanoglou P, Abrahamyan L, MacKeigan L, Consiglio GP, Dolovich L, Li P, Cadarette SM, Rac VE, Shin J, Krahn M. Factors affecting the delivery of community pharmacist-led medication reviews: evidence from the MedsCheck annual service in Ontario. BMC Health Serv Res. 2016 Nov 21;16(1):666. doi: 10.1186/s12913-016-1888-2.

  PMID: 27871324 BACKGROUND

• Slater M, Bielecki J, Alba AC, Abrahamyan L, Tomlinson G, Mak S, MacIver J, Zieroth S, Lee D, Wong W, Krahn M, Ross H, Rac VE. Comparative effectiveness of the different components of care provided in heart failure clinics-protocol for a systematic review and network meta-analysis. Syst Rev. 2019 Feb 2;8(1):40. doi: 10.1186/s13643-019-0953-4.

  PMID: 30711016 BACKGROUND

• Nolan RP, Payne AY, Ross H, White M, D'Antono B, Chan S, Barr SI, Gwadry-Sridhar F, Nigam A, Perreault S, Farkouh M, McDonald M, Goodman J, Thomas S, Zieroth S, Isaac D, Oh P, Rajda M, Chen M, Eysenbach G, Liu S, Zbib A. An Internet-Based Counseling Intervention With Email Reminders that Promotes Self-Care in Adults With Chronic Heart Failure: Randomized Controlled Trial Protocol. JMIR Res Protoc. 2014 Jan 30;3(1):e5. doi: 10.2196/resprot.2957.

  PMID: 24480783 BACKGROUND

• Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992 Jun;30(6):473-83.

  PMID: 1593914 BACKGROUND

• Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.

  PMID: 16717171 BACKGROUND

• Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.

  PMID: 11556941 BACKGROUND

• Mitchell PH, Powell L, Blumenthal J, Norten J, Ironson G, Pitula CR, Froelicher ES, Czajkowski S, Youngblood M, Huber M, Berkman LF. A short social support measure for patients recovering from myocardial infarction: the ENRICHD Social Support Inventory. J Cardiopulm Rehabil. 2003 Nov-Dec;23(6):398-403. doi: 10.1097/00008483-200311000-00001. No abstract available.

  PMID: 14646785 BACKGROUND

• Lorig KR, Sobel DS, Ritter PL, Laurent D, Hobbs M. Effect of a self-management program on patients with chronic disease. Eff Clin Pract. 2001 Nov-Dec;4(6):256-62.

  PMID: 11769298 BACKGROUND

• Ryff CD. In the eye of the beholder: views of psychological well-being among middle-aged and older adults. Psychol Aging. 1989 Jun;4(2):195-201. doi: 10.1037//0882-7974.4.2.195.

  PMID: 2789747 BACKGROUND

• Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009 Apr;42(2):377-81. doi: 10.1016/j.jbi.2008.08.010. Epub 2008 Sep 30.

  PMID: 18929686 BACKGROUND

• Harris PA, Taylor R, Minor BL, Elliott V, Fernandez M, O'Neal L, McLeod L, Delacqua G, Delacqua F, Kirby J, Duda SN; REDCap Consortium. The REDCap consortium: Building an international community of software platform partners. J Biomed Inform. 2019 Jul;95:103208. doi: 10.1016/j.jbi.2019.103208. Epub 2019 May 9.

  PMID: 31078660 BACKGROUND

• Nolan RP, Feldman R, Dawes M, Kaczorowski J, Lynn H, Barr SI, MacPhail C, Thomas S, Goodman J, Eysenbach G, Liu S, Tanaka R, Surikova J. Randomized Controlled Trial of E-Counseling for Hypertension: REACH. Circ Cardiovasc Qual Outcomes. 2018 Jul;11(7):e004420. doi: 10.1161/CIRCOUTCOMES.117.004420.

  PMID: 30006474 BACKGROUND

• Nolan RP, Liu S, Feldman R, Dawes M, Barr S, Lynn H, Gwardy-Sridhar F, Thomas SG, Goodman J, Oh P, Kaczorowski J, Chessex C, Hachinski V, Shoemaker K. Reducing risk with e-based support for adherence to lifestyle change in hypertension (REACH): protocol for a multicentred randomised controlled trial. BMJ Open. 2013 Aug 21;3(8):e003547. doi: 10.1136/bmjopen-2013-003547.

  PMID: 23965936 BACKGROUND

• Liu S, Tanaka R, Barr S, Nolan RP. Effects of self-guided e-counseling on health behaviors and blood pressure: Results of a randomized trial. Patient Educ Couns. 2020 Mar;103(3):635-641. doi: 10.1016/j.pec.2019.10.007. Epub 2019 Oct 19.

  PMID: 31669047 BACKGROUND

• United States Renal Data System. 2022 USRDS Annual Data Report: Epidemiology of kidney disease in the United States. (National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD).

  BACKGROUND

• Nguyen NTQ, Cockwell P, Maxwell AP, Griffin M, O'Brien T, O'Neill C. Chronic kidney disease, health-related quality of life and their associated economic burden among a nationally representative sample of community dwelling adults in England. PLoS One. 2018 Nov 26;13(11):e0207960. doi: 10.1371/journal.pone.0207960. eCollection 2018.

  PMID: 30475893 BACKGROUND

• Information, C. I. f. H. Annual statistics on organ replacement in Canada, 2011 to 2020. (2021).

  BACKGROUND

• Mendelssohn DC, Mujais SK, Soroka SD, Brouillette J, Takano T, Barre PE, Mittal BV, Singh A, Firanek C, Story K, Finkelstein FO. A prospective evaluation of renal replacement therapy modality eligibility. Nephrol Dial Transplant. 2009 Feb;24(2):555-61. doi: 10.1093/ndt/gfn484. Epub 2008 Aug 28.

  PMID: 18755848 BACKGROUND

• Krahn MD, Bremner KE, de Oliveira C, Dixon SN, McFarlane P, Garg AX, Mitsakakis N, Blake PG, Harvey R, Pechlivanoglou P. Home Dialysis Is Associated with Lower Costs and Better Survival than Other Modalities: A Population-Based Study in Ontario, Canada. Perit Dial Int. 2019 Nov-Dec;39(6):553-561. doi: 10.3747/pdi.2018.00268. Epub 2019 Oct 3.

  PMID: 31582466 BACKGROUND

• Trinh E, Chan CT, Perl J. Dialysis modality and survival: Done to death. Semin Dial. 2018 Jul;31(4):315-324. doi: 10.1111/sdi.12692. Epub 2018 Mar 14.

  PMID: 29539161 BACKGROUND

• Ludlow MJ, George CR, Hawley CM, Mathew TH, Agar JW, Kerr PG, Lauder LA. How Australian nephrologists view home dialysis: results of a national survey. Nephrology (Carlton). 2011 May;16(4):446-52. doi: 10.1111/j.1440-1797.2010.01403.x.

  PMID: 21518119 BACKGROUND

• Kutner NG, Zhang R, Huang Y, Wasse H. Patient awareness and initiation of peritoneal dialysis. Arch Intern Med. 2011 Jan 24;171(2):119-24. doi: 10.1001/archinternmed.2010.361. Epub 2010 Sep 27.

  PMID: 20876396 BACKGROUND

• Van Biesen W, van der Veer SN, Murphey M, Loblova O, Davies S. Patients' perceptions of information and education for renal replacement therapy: an independent survey by the European Kidney Patients' Federation on information and support on renal replacement therapy. PLoS One. 2014 Jul 31;9(7):e103914. doi: 10.1371/journal.pone.0103914. eCollection 2014.

  PMID: 25079071 BACKGROUND

• Brunori G, Reboldi G, Aucella F. Lessons Learnt during the COVID-19 Pandemic: For Patients with End-Stage Renal Disease, We Should Prioritize Home-Based Treatment and Telemedicine. Kidney Blood Press Res. 2021;46(1):11-16. doi: 10.1159/000512629. Epub 2021 Jan 29.

  PMID: 33517338 BACKGROUND

• Andrassy KM. Comments on 'KDIGO 2012 Clinical Practice Guideline for the Evaluation and Management of Chronic Kidney Disease'. Kidney Int. 2013 Sep;84(3):622-3. doi: 10.1038/ki.2013.243. No abstract available.

  PMID: 23989362 BACKGROUND

• Walker AMN, Drozd M, Hall M, Patel PA, Paton M, Lowry J, Gierula J, Byrom R, Kearney L, Sapsford RJ, Witte KK, Kearney MT, Cubbon RM. Prevalence and Predictors of Sepsis Death in Patients With Chronic Heart Failure and Reduced Left Ventricular Ejection Fraction. J Am Heart Assoc. 2018 Oct 16;7(20):e009684. doi: 10.1161/JAHA.118.009684.

  PMID: 30371261 BACKGROUND

• Granger BB, Swedberg K, Ekman I, Granger CB, Olofsson B, McMurray JJ, Yusuf S, Michelson EL, Pfeffer MA; CHARM investigators. Adherence to candesartan and placebo and outcomes in chronic heart failure in the CHARM programme: double-blind, randomised, controlled clinical trial. Lancet. 2005 Dec 10;366(9502):2005-11. doi: 10.1016/S0140-6736(05)67760-4.

  PMID: 16338449 BACKGROUND

• Bramley TJ, Gerbino PP, Nightengale BS, Frech-Tamas F. Relationship of blood pressure control to adherence with antihypertensive monotherapy in 13 managed care organizations. J Manag Care Pharm. 2006 Apr;12(3):239-45. doi: 10.18553/jmcp.2006.12.3.239.

  PMID: 16623608 BACKGROUND

• Authority, C. I. R. Canada's Internet Factbook 2018: Canada's source for current internet data. (2018).

  BACKGROUND

• Center, P. R. Internet/Broadband Fact Sheet, <https://www.pewresearch.org/internet/fact-sheet/internet-broadband/> (2021).

  BACKGROUND

• (CIHI), C. I. f. H. I. CIHI, <https://www.cihi.ca/en>

  BACKGROUND

• Nolan RP, Ross HJ, Farkouh ME, Huszti E, Chan S, Toma M, D'Antono B, White M, Thomas S, Barr SI, Perreault S, McDonald M, Zieroth S, Isaac D, Wielgosz A, Mielniczuk LM. Automated E-Counseling for Chronic Heart Failure: CHF-CePPORT Trial. Circ Heart Fail. 2021 Jan;14(1):e007073. doi: 10.1161/CIRCHEARTFAILURE.120.007073. Epub 2021 Jan 19.

  PMID: 33464959 BACKGROUND

• Fezza, G., Sansone, S., Surikova, J., Ross, H. & Nolan, R. Patient Engagement with an Ecounseling Platform is Enhanced Over 12 Months in the CHF-CePPORT Trial. Canadian Journal of Cardiology 34, S148-S149 (2018). https://doi.org:10.1016/j.cjca.2018.07.184

  BACKGROUND

• Payne AY, Surikova J, Liu S, Ross H, Mechetiuc T, Nolan RP. Usability Testing of an Internet-Based e-Counseling Platform for Adults With Chronic Heart Failure. JMIR Hum Factors. 2015 May 8;2(1):e7. doi: 10.2196/humanfactors.4125.

  PMID: 27026267 BACKGROUND

• Wong JV, Yang GJ, Auguste BL, Ong SW, Logan AG, Chan CT, Nolan RP. Automated Digital Counseling Program (ODYSSEE-Kidney Health): A Pilot Study on Health-Related Quality of Life. Kidney360. 2023 Oct 1;4(10):1397-1406. doi: 10.34067/KID.0000000000000229. Epub 2023 Aug 14.

  PMID: 37578528 BACKGROUND

• Hays, R. D. et al. Kidney disease quality of life short form (KDQOL-SF™), version 1.3: a manual for use and scoring. Santa Monica, CA: Rand 7994 (1997).

  BACKGROUND

• Kasser, T., & Ryan, R. M. Aspiration Index [Database record]. APA PsycTests (1993).

  BACKGROUND

• Sheldon, K. M. & Hilpert, J. C. The balanced measure of psychological needs (BMPN) scale: An alternative domain general measure of need satisfaction. Motivation and Emotion 36, 439-451 (2012). https://doi.org:10.1007/s11031-012-9279-4

  BACKGROUND

• Scarpa MP, Zopluoglu C, Prilleltensky I. Assessing multidimensional mattering: Development and exploratory validation of the Mattering in Domains of Life Scale (MIDLS). J Community Psychol. 2022 Apr;50(3):1430-1453. doi: 10.1002/jcop.22725. Epub 2021 Oct 4.

  PMID: 34561863 BACKGROUND

• (CIHI), C. I. f. H. I. What is the data request process at CIHI?, <https://www.cihi.ca/en/faq/what-is-the-data-request-process-at-cihi>

  BACKGROUND

• Network, O. R. Living with Chronic Kidney Disease, <https://www.ontariorenalnetwork.ca/en/kidney-care-resources/living-with-chronic-kidney-disease>

  BACKGROUND

• Foundation, K. Living with Kidney Failure, <https://kidney.ca/Kidney-Health/Living-With-Kidney-Failure> (

  BACKGROUND

• Miller, W. R. & Rollnick, S. Motivational interviewing: Helping people change, 3rd edition. (Guilford Press, 2013).

  BACKGROUND

• Weddington, W. W., Jr. Facilitating Treatment Adherence: A Practitioner's Guidebook. JAMA 260, 273-273 (1988). https://doi.org:10.1001/jama.1988.03410020139051

  BACKGROUND

• (CIHI), C. I. f. H. I. About CIHI, <https://www.cihi.ca/en/about-cihi> (

  BACKGROUND

• Trinh E, Hanley JA, Nadeau-Fredette AC, Perl J, Chan CT. A comparison of technique survival in Canadian peritoneal dialysis and home hemodialysis patients. Nephrol Dial Transplant. 2019 Nov 1;34(11):1941-1949. doi: 10.1093/ndt/gfz075.

  PMID: 31329952 BACKGROUND

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Robert Nolan, PhD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Robert Nolan, PhD

CONTACT

(416) 340-4800; rob.nolan@uhn.ca

Janice Montbriand, Phd

CONTACT

(416) 340-4800; janice.montbriand@uhn.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2023
• First Posted: February 23, 2024
• Study Start: December 13, 2023
• Primary Completion: April 13, 2026
• Study Completion: April 13, 2026
• Last Updated: December 12, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)