Automated digital counselling with social network support as a novel intervention for patients with heart failure: protocol for randomised controlled trial.
Clinical trials
Heart failure
Quality in health care
Telemedicine
World Wide Web technology
Journal
BMJ open
ISSN: 2044-6055
Titre abrégé: BMJ Open
Pays: England
ID NLM: 101552874
Informations de publication
Date de publication:
05 09 2022
05 09 2022
Historique:
entrez:
23
1
2023
pubmed:
24
1
2023
medline:
26
1
2023
Statut:
epublish
Résumé
Heart failure (HF) symptoms improve through self-care, for which adherence remains low among patients despite the provision of education for these behaviours by clinical teams. Open Access Digital Community Promoting Self-Care, Peer Support and Health Literacy (ODYSSEE-vCHAT) combines automated digital counselling with social network support to improve mortality and morbidity, engagement with self-care materials, and health-related quality of life. Use of ODYSSEE-vCHAT via Internet-connected personal computer by 162 HF patients will be compared with a control condition over 22 months. The primary outcome is a composite index score of all-cause mortality, all-cause emergency department visits, and HF-related hospitalisation at trial completion. Secondary outcomes include individual components of the composite index, engagement with self-care materials, and patient-reported measures of physical and psychosocial well-being, disease management, health literacy, and substance use. Patients are recruited from tertiary care hospitals in Toronto, Canada and randomised on a 1:1 ratio to both arms of the trial. Online assessments occur at baseline (t=0), months 4, 8 and 12, and trial completion. Ordinal logistic regression analyses and generalised linear models will evaluate primary and secondary outcomes. The trial has been approved by the research ethics boards at the University Health Network (20-5960), Sunnybrook Hospital (5117), and Mount Sinai Hospital (21-022-E). Informed consent of eligible patients occurs in person or online. Findings will be shared with key stakeholders and the public. Results will allow for the preparation of a Canada-wide phase III trial to evaluate the efficacy of ODYSSEE-vCHAT in improving clinical outcomes and raising the standard of outpatient care. NCT04966104.
Identifiants
pubmed: 36691152
pii: bmjopen-2021-059635
doi: 10.1136/bmjopen-2021-059635
pmc: PMC9445232
doi:
Banques de données
ClinicalTrials.gov
['NCT04966104']
Types de publication
Clinical Trial Protocol
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
e059635Subventions
Organisme : CIHR
ID : PJT173222
Pays : Canada
Informations de copyright
© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
Déclaration de conflit d'intérêts
Competing interests: None declared.
Références
J Med Internet Res. 2010 Nov 29;12(4):e55
pubmed: 21115435
Heart Lung. 2002 May-Jun;31(3):161-72
pubmed: 12011807
Can J Cardiol. 2017 Nov;33(11):1342-1433
pubmed: 29111106
Haemophilia. 2013 Nov;19(6):876-81
pubmed: 23834537
Gen Hosp Psychiatry. 2010 Jul-Aug;32(4):345-59
pubmed: 20633738
Harv Rev Psychiatry. 2018 Jul/Aug;26(4):175-184
pubmed: 29975336
Cardiovasc Ther. 2013 Aug;31(4):230-7
pubmed: 23061492
Eur J Heart Fail. 2005 Mar 16;7(3):419-22
pubmed: 15718183
Circulation. 2017 Mar 28;135(13):1214-1223
pubmed: 28174193
Circulation. 2009 Sep 22;120(12):1141-63
pubmed: 19720935
J Cardiovasc Nurs. 2006 May-Jun;21(3):232-41
pubmed: 16699364
Arch Intern Med. 2006 May 22;166(10):1092-7
pubmed: 16717171
Int J Nurs Knowl. 2018 Jul;29(3):146-155
pubmed: 28523764
PLoS Med. 2008 Jan 8;5(1):e12
pubmed: 18184033
Int J Nurs Stud. 2003 Mar;40(3):321-32
pubmed: 12605954
J Am Coll Cardiol. 2000 Apr;35(5):1245-55
pubmed: 10758967
JACC Heart Fail. 2013 Feb;1(1):1-20
pubmed: 24621794
Congest Heart Fail. 2013 Jan-Feb;19(1):16-24
pubmed: 22958604
BMC Med Res Methodol. 2015 Aug 12;15:60
pubmed: 26264621
BMJ. 2019 Feb 13;364:l223
pubmed: 30760447
Circulation. 2016 Jan 26;133(4):e38-360
pubmed: 26673558
J Am Coll Cardiol. 2016 Feb 9;67(5):476-85
pubmed: 26562047
Circ Heart Fail. 2021 Jan;14(1):e007073
pubmed: 33464959
JMIR Res Protoc. 2014 Jan 30;3(1):e5
pubmed: 24480783
Int J Epidemiol. 2019 Aug 1;48(4):1167-1174
pubmed: 30721947
J Card Fail. 2009 Aug;15(6):508-16
pubmed: 19643362
Spine (Phila Pa 1976). 2000 Dec 15;25(24):3130-9
pubmed: 11124729
Heart Lung. 2009 Mar-Apr;38(2):100-8
pubmed: 19254628
Circ Heart Fail. 2012 Jul 1;5(4):414-21
pubmed: 22556322
J Card Fail. 2006 Oct;12(8):621-7
pubmed: 17045181
Heart Fail Clin. 2015 Jan;11(1):29-36
pubmed: 25432472
JAMA. 2007 Jan 10;297(2):177-86
pubmed: 17213401
Health Qual Life Outcomes. 2004 May 13;2:24
pubmed: 15142277
Eur J Heart Fail. 2009 Jan;11(1):99-105
pubmed: 19147463
Circ Cardiovasc Qual Outcomes. 2012 Jul 1;5(4):571-6
pubmed: 22811499
Br J Health Psychol. 2020 May;25(2):233-256
pubmed: 31999891
J Med Internet Res. 2019 Aug 05;21(8):e12914
pubmed: 31381504
Circ Heart Fail. 2012 Mar 1;5(2):160-6
pubmed: 22247483
BMJ. 2006 Jul 1;333(7557):15
pubmed: 16790458
BMJ. 2013 Jan 08;346:e7586
pubmed: 23303884
Heart Rhythm. 2020 Sep;17(9):e233-e241
pubmed: 32247013
JMIR Hum Factors. 2015 May 08;2(1):e7
pubmed: 27026267
Congest Heart Fail. 2005 Nov-Dec;11(6):315-21
pubmed: 16330907
Cochrane Database Syst Rev. 2007 Oct 17;(4):CD002990
pubmed: 17943778
Health Psychol. 2013 Jun;32(6):637-46
pubmed: 22746258
Eur J Prev Cardiol. 2021 Dec 29;28(15):1682-1690
pubmed: 33571994
Congest Heart Fail. 2007 May-Jun;13(3):149-57
pubmed: 17541307
Am Heart J. 2005 Oct;150(4):707-15
pubmed: 16209970
BMC Cardiovasc Disord. 2017 Feb 15;17(1):51
pubmed: 28196523
Circulation. 2010 Mar 30;121(12):1393-405
pubmed: 20231531
Eff Clin Pract. 2001 Nov-Dec;4(6):256-62
pubmed: 11769298
Qual Life Res. 2013 Sep;22(7):1555-63
pubmed: 23076798
Patient Educ Couns. 2016 Feb;99(2):256-64
pubmed: 26358533
J Hosp Med. 2009 Oct;4(8):512-4
pubmed: 19824102
J Cardiovasc Nurs. 2004 May-Jun;19(3):174-83
pubmed: 15191260
Int J Nurs Stud. 2014 Feb;51(2):320-33
pubmed: 23850389
N Engl J Med. 1999 Feb 25;340(8):609-16
pubmed: 10029645
JAMA Intern Med. 2015 Nov;175(11):1773-82
pubmed: 26414759
Addiction. 2012 May;107(5):957-66
pubmed: 22126102
Lancet. 2005 Dec 10;366(9502):2005-11
pubmed: 16338449
Int Heart J. 2015;56(5):475-84
pubmed: 26346520
Diabetes Technol Ther. 2012 Oct;14(10):858-61
pubmed: 22856588
Cochrane Database Syst Rev. 2010 Aug 04;(8):CD007228
pubmed: 20687083