CONTEXT: Motivating patients with heart failure to adhere to medical advice has not translated into clinical benefit, but past trials have had methodological limitations. OBJECTIVE: To determine the value of self-management counseling plus heart failure education, compared with heart failure education alone, for the primary end point of death or heart failure hospitalization. DESIGN, SETTING, AND PATIENTS: The Heart Failure Adherence and Retention Trial (HART), a single-center, multiple-hospital, partially blinded behavioral efficacy randomized controlled trial involving 902 patients with mild to moderate heart failure and reduced or preserved systolic function, randomized from the Chicago metropolitan area between October 2001 and October 2004 and undergoing follow-up for 2 to 3 subsequent years. INTERVENTIONS:All patients were offered 18 contacts and 18 heart failure educational tip sheets during the course of 1 year. Patients randomized to the education group received tip sheets in the mail and telephone calls to check comprehension. Patients randomized to the self-management group received tip sheets in groups and were taught self-management skills to implement the advice. MAIN OUTCOME MEASURE: Death or heart failure hospitalization during a median of 2.56 years of follow-up. RESULTS:Patients were representative of typical clinical populations (mean age, 63.6 years; 47% women, 40% racial/ethnic minority, 52% with annual family income less than $30,000, and 23% with preserved systolic function). The rate of the primary end point in the self-management group was no different from that in the education group (163 [40.1%)] vs 171 [41.2%], respectively; odds ratio, 0.95 [95% confidence interval, 0.72-1.26]). There were no significant differences on any secondary end points, including death, heart failure hospitalization, all-cause hospitalization, or quality of life. CONCLUSIONS: Compared with an enhanced educational intervention alone, the addition of self-management counseling did not reduce death or heart failure hospitalization in patients with mild to moderate heart failure. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00018005.
RCT Entities:
CONTEXT: Motivating patients with heart failure to adhere to medical advice has not translated into clinical benefit, but past trials have had methodological limitations. OBJECTIVE: To determine the value of self-management counseling plus heart failure education, compared with heart failure education alone, for the primary end point of death or heart failure hospitalization. DESIGN, SETTING, AND PATIENTS: The Heart Failure Adherence and Retention Trial (HART), a single-center, multiple-hospital, partially blinded behavioral efficacy randomized controlled trial involving 902 patients with mild to moderate heart failure and reduced or preserved systolic function, randomized from the Chicago metropolitan area between October 2001 and October 2004 and undergoing follow-up for 2 to 3 subsequent years. INTERVENTIONS: All patients were offered 18 contacts and 18 heart failure educational tip sheets during the course of 1 year. Patients randomized to the education group received tip sheets in the mail and telephone calls to check comprehension. Patients randomized to the self-management group received tip sheets in groups and were taught self-management skills to implement the advice. MAIN OUTCOME MEASURE: Death or heart failure hospitalization during a median of 2.56 years of follow-up. RESULTS:Patients were representative of typical clinical populations (mean age, 63.6 years; 47% women, 40% racial/ethnic minority, 52% with annual family income less than $30,000, and 23% with preserved systolic function). The rate of the primary end point in the self-management group was no different from that in the education group (163 [40.1%)] vs 171 [41.2%], respectively; odds ratio, 0.95 [95% confidence interval, 0.72-1.26]). There were no significant differences on any secondary end points, including death, heart failure hospitalization, all-cause hospitalization, or quality of life. CONCLUSIONS: Compared with an enhanced educational intervention alone, the addition of self-management counseling did not reduce death or heart failure hospitalization in patients with mild to moderate heart failure. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00018005.
Authors: Peter A McCullough; Edward F Philbin; John A Spertus; Scott Kaatz; Keisha R Sandberg; W Douglas Weaver Journal: J Am Coll Cardiol Date: 2002-01-02 Impact factor: 24.094
Authors: S P Wright; H Walsh; K M Ingley; S A Muncaster; G D Gamble; A Pearl; G A Whalley; N Sharpe; R N Doughty Journal: Eur J Heart Fail Date: 2003-06 Impact factor: 15.534
Authors: Margaret B Harrison; Gina B Browne; Jacqueline Roberts; Peter Tugwell; Amiram Gafni; Ian D Graham Journal: Med Care Date: 2002-04 Impact factor: 2.983
Authors: Aram V Chobanian; George L Bakris; Henry R Black; William C Cushman; Lee A Green; Joseph L Izzo; Daniel W Jones; Barry J Materson; Suzanne Oparil; Jackson T Wright; Edward J Roccella Journal: JAMA Date: 2003-05-14 Impact factor: 56.272
Authors: Christopher O Phillips; Scott M Wright; David E Kern; Ramesh M Singa; Sasha Shepperd; Haya R Rubin Journal: JAMA Date: 2004-03-17 Impact factor: 56.272
Authors: Shivan J Mehta; Kevin G Volpp; David A Asch; Lee R Goldberg; Louise B Russell; Laurie A Norton; Lauren G Iannotte; Andrea B Troxel Journal: Circ Cardiovasc Qual Outcomes Date: 2019-04
Authors: Kavita Radhakrishnan; Paul Toprac; Matt O'Hair; Randolph Bias; Miyong T Kim; Paul Bradley; Michael Mackert Journal: Games Health J Date: 2016-10-24
Authors: Michele Heisler; Lakshmi Halasyamani; Mark E Cowen; Matthew D Davis; Ken Resnicow; Robert L Strawderman; Hwajung Choi; Rebecca Mase; John D Piette Journal: Circ Heart Fail Date: 2013-02-06 Impact factor: 8.790