Robert P Nolan1,2, Heather J Ross3,2, Michael E Farkouh3,2, Ella Huszti4, Sammy Chan5,6, Mustafa Toma5,6, Bianca D'Antono7,8,9, Michel White7, Scott Thomas10, Susan I Barr11, Sylvie Perreault12, Michael McDonald3,2, Shelley Zieroth13, Debra Isaac14, Andreas Wielgosz15, Lisa Marie Mielniczuk16. 1. Cardiac eHealth and Behavioural Cardiology Research Unit, Peter Munk Cardiac Center (R.P.N.), University Health Network, Toronto, ON, Canada. 2. Faculty of Medicine (R.P.N., H.J.R., M.E.F., M.M.), University of Toronto, ON, Canada. 3. Division of Cardiology, Peter Munk Cardiac Center (H.J.R., M.E.F., M.M.), University Health Network, Toronto, ON, Canada. 4. Theta Institute (E.H.), University Health Network, Toronto, ON, Canada. 5. Faculty of Medicine (S.C., M.T.), University of British Columbia, Vancouver, Canada. 6. Department of Cardiology, St Paul's Hospital, Vancouver, BC, Canada (S.C., M.T.). 7. Centre de Recherche, Institut de Cardiologie de Montréal, QC, Canada (B.D., M.W.). 8. Département de Psychologie (B.D.). 9. Université de Montréal, QC, Canada (B.D.). 10. Faculty of Kinesiology and Physical Education (S.T.), University of Toronto, ON, Canada. 11. Department of Food, Nutrition, and Health (S.I.B.), University of British Columbia, Vancouver, Canada. 12. Faculté de Pharmacie (S.P.). 13. Faculty of Medicine, University of Manitoba, Winnipeg, Canada (S.Z.). 14. Cardiac Transplant Clinic, Libin Cardiovascular Institute of Alberta, Calgary, Canada (D.I.). 15. Department of Medicine, University of Ottawa, Canada (A.W.). 16. University of Ottawa Heart Institute, ON, Canada (L.M.M.).
Abstract
BACKGROUND: International task force statements advocate telehealth programs to promote health-related quality of life for patients with chronic heart failure (CHF). To that end, we evaluated the efficacy and usability of an automated e-counseling program. METHODS: This Canadian multi-site double-blind randomized trial assessed whether usual care plus either internet-based e-counseling (motivational and cognitive-behavioral tools for CHF self-care) or e-based conventional CHF self-care education (e-UC) improved 12-month Kansas City Cardiomyopathy Questionnaire Overall Summary (KCCQ-OS). Secondary outcomes included program engagement (total logon weeks, logons, and logon hours), total CHF self-care behaviors, diet (fruit and vegetable servings), 6-minute walk test, and 4-day step count. The association between program engagement and health-related quality of life was assessed using KCCQ-OS tertiles. RESULTS:We enrolled 231 patients, median age =59.5 years, 22% female, and elevated median KCCQ-OS=83.0 (interquartile range, 68-93). KCCQ-OS increase ≥5 points was not more prevalent for e-counseling, n=29 (29.6%) versus e-UC, n=32 (34.0%), P=0.51. E-Counseling versus e-UC increased total logon weeks (P=0.02), logon hours (P=0.001), and logons (P<0.001). Only e-counseling showed a positive association between 12-month KCCQ-OS tertile and logon weeks (P=0.04) and logon hours (P=0.004). E-Counseling increased CHF self-care behavior and diet but not 6-minute walk test or 4-day step count. CONCLUSIONS: The primary KCCQ-OS end point was negative for this trial. Only e-counseling showed a positive association between program engagement and 12-month KCCQ-OS tertile, and it improved CHF self-care behavior and diet. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01864369.
RCT Entities:
BACKGROUND: International task force statements advocate telehealth programs to promote health-related quality of life for patients with chronic heart failure (CHF). To that end, we evaluated the efficacy and usability of an automated e-counseling program. METHODS: This Canadian multi-site double-blind randomized trial assessed whether usual care plus either internet-based e-counseling (motivational and cognitive-behavioral tools for CHF self-care) or e-based conventional CHF self-care education (e-UC) improved 12-month Kansas City Cardiomyopathy Questionnaire Overall Summary (KCCQ-OS). Secondary outcomes included program engagement (total logon weeks, logons, and logon hours), total CHF self-care behaviors, diet (fruit and vegetable servings), 6-minute walk test, and 4-day step count. The association between program engagement and health-related quality of life was assessed using KCCQ-OS tertiles. RESULTS: We enrolled 231 patients, median age =59.5 years, 22% female, and elevated median KCCQ-OS=83.0 (interquartile range, 68-93). KCCQ-OS increase ≥5 points was not more prevalent for e-counseling, n=29 (29.6%) versus e-UC, n=32 (34.0%), P=0.51. E-Counseling versus e-UC increased total logon weeks (P=0.02), logon hours (P=0.001), and logons (P<0.001). Only e-counseling showed a positive association between 12-month KCCQ-OS tertile and logon weeks (P=0.04) and logon hours (P=0.004). E-Counseling increased CHF self-care behavior and diet but not 6-minute walk test or 4-day step count. CONCLUSIONS: The primary KCCQ-OS end point was negative for this trial. Only e-counseling showed a positive association between program engagement and 12-month KCCQ-OS tertile, and it improved CHF self-care behavior and diet. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01864369.