The Heart Failure Adherence and Retention Trial (HART): Design and rationale

doi:10.1016/j.ahj.2008.05.011

American Heart Journal

Volume 156, Issue 3, September 2008, Pages 452-460

https://doi.org/10.1016/j.ahj.2008.05.011 Get rights and content

Background

Heart failure (HF) is increasing in prevalence and is associated with prolonged morbidity, repeat hospitalizations, and high costs. Drug therapies and lifestyle changes can reduce hospitalizations, but nonadherence is high, ranging from 30% to 80%. There is an urgent need to identify cost-effective ways to improve adherence and reduce hospitalizations.

Trial Design

The Heart Failure Adherence and Retention Trial (HART) evaluated the benefit of patient self-management (SM) skills training in combination with HF education, over HF education alone, on the composite end points of death/HF hospitalizations and death/all-cause hospitalizations in patients with mild to moderate systolic or diastolic dysfunction. Secondary end points included progression of HF, quality of life, adherence to drug and lifestyle regimens, and psychosocial function. The HART cohort was composed of 902 patients including 47% women, 40% minorities, and 23% with diastolic dysfunction. After a baseline examination, patients were randomized to SM or education control, received 18 treatment contacts over 1 year, annual follow-ups, and 3-month phone calls to assess primary end points. Self-management treatment was conducted in small groups and aimed to activate the patient to implement HF education through training in problem-solving and 5 SM skills. The education control received HF education in the mail followed by a phone call to check comprehension.

Conclusions

The significance of HART lies in its ability to determine the clinical value of activating the patient to collaborate in his or her care. Support for the trial hypotheses would encourage interdisciplinary HF treatment, drawing on an evidence base not only from medicine but also from behavioral medicine.

Section snippets

Aims and hypotheses

HART was designed to determine whether a patient SM intervention significantly improved clinically important outcomes, relative to an education control, in patients with mild to moderate systolic and/or diastolic HF. Two clinically important composite outcomes served as the primary end points: (1) death or hospitalizations for HF and (2) death or all-cause hospitalizations.

Figure 1 shows the pathway by which the SM intervention was hypothesized to translate into benefit on the primary end

Trial organization

HART incorporates features of phase 3 therapeutic clinical trials, modified as needed to address the unique nature of the trial. The large size of the Chicago metropolitan area made it possible to conduct the trial entirely in the city and its suburbs, with Rush University Medical Center serving as the coordinating center. The trial was run by an Executive Committee (which also served as the Steering Committee), chaired by the Principal Investigator (L.H.P.), and cochaired by the 2 coprincipal

Discussion

The significance of HART, one of the largest behavioral trials in HF conducted, lies in its ability to determine the clinical value of activating the patient to collaborate in his or her care. HART was designed on the assumption that a chronic illness like HF requires a shift from an acute care model of disease to one of collaborative management.⁴¹ This is essentially equivalent to shifting from a model where the provider prescribes and the patient passively receives, to one in which the

References (42)

P.A. McCullough et al.
Confirmation of a heart failure epidemic: findings from the resource utilization among congestive heart failure (REACH) study
J Am Coll Cardiol
(2002)
S.A. Hunt et al.
ACC/AHA guidelines for the evaluation and management of chronic heart failure in the adult: executive summary: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines
J Am Coll Cardiol
(2001)
B.M. Massie et al.
Evolving trends in the epidemiologic factors of heart failure: rationale for preventive strategies and comprehensive disease management
Am Heart J
(1997)
M.H.L. van der Wal et al.
Adherence in heart failure in the elderly: problem and possible solutions
Int J Cardiol
(2008)
F.A. McAlister et al.
Multidisciplinary strategies for the management of heart failure patients at high risk for admission. A systematic review of randomized trials
J Am Coll Cardiol
(2004)
J. Barlow et al.
Self-management approaches for people with chronic conditions: a review
Patient Educ Couns
(2002)
L.S. Evangelista et al.
Relationship between psychosocial variables and compliance in patients with heart failure
Heart Lung
(2001)
M. Friedman et al.
Alteration of type A behavior and reduction in cardiac recurrences in post-myocardial infarction subjects
Am Heart J
(1984)
P. Faggiano et al.
Assessment of oxygen uptake during the 6-minute walking test in patients with heart failure: preliminary experience with a portable device
Am Heart J
(1997)
R.F. DeBusk
MULTIFIT. A new approach to risk factor modification
Cardiol Clin
(1996)

J.A. Yesavage et al.

Development and validation of a geriatric depression screening scale: a preliminary report

J Psychiat Res

(1983)

C.D. Sherbourne et al.

The MOS social support survey

Soc Sci Med

(1991)

C.S. Rucker-Whitaker et al.

Understanding African-American participation in a behavioral intervention: results from focus groups

Contemp Clin Trials

(2006)

E. Braunwald

Shattuck lecture: cardiovascular medicine at the turn of the millennium: triumphs, concerns, and opportunities

N Engl J Med

(1997)

V.L. Roger et al.

Trends in heart failure incidence and survival in a community-based population

JAMA

(2004)

R.V. Aghababian

Acutely decompensated heart failure: opportunities to improve care and outcomes in the emergency department

Rev Cardiovasc Med

(2002)

W. Rosamond et al.

Heart disease and stroke statistics—2007 update. A report from the American Heart Association Statistics Committee and Stroke Statistics Subcommittee

Circulation

(2007)

M. Jessup et al.

Medical progress: heart failure

New Engl J Med

(2003)

A.T. Kozak et al.

Elements of nonpharmacologic interventions that prevent progression of heart failure: a meta-analysis

Congest Heart Fail

(2007)

F. Gwadry-Sridhar et al.

A systematic review and meta-analysis of studies comparing readmission rates and mortality rates in patients with heart failure

Arch Intern Med

(2004)

C.O. Phillips et al.

Comprehensive discharge planning with postdischarge support for older patients with congestive heart failure

JAMA

(2004)

Cited by (27)

Impact of physical inactivity on mortality in patients with heart failure
2016, American Journal of Cardiology
Citation Excerpt :
HART assessed the impact of self-management counseling versus education alone on the primary outcome of death or HF-related hospitalization in patients with symptomatic HF. Details of the trial were reported elsewhere.4,5 The study enrolled patients from 10 centers in the Chicago metropolitan area and was approved by the institutional review board of each collaborating institution [NCT00018005].
The impact of physical inactivity on heart failure (HF) mortality is unclear. We analyzed data from the HF Adherence and Retention Trial (HART) which enrolled 902 patients with New York Heart Association class II/III HF, with preserved or reduced ejection fraction, who were followed for 36 months. On the basis of mean self-reported weekly exercise duration, patients were classified into inactive (0 min/week) and active (≥1 min/week) groups and then propensity score matched according to 34 baseline covariates in 1:2 ratio. Sedentary activity was determined according to self-reported daily television screen time (<2, 2 to 4, >4 h/day). The primary outcome was all-cause death. Secondary outcomes were cardiac death and HF hospitalization. There were 196 inactive patients, of whom 171 were propensity matched to 342 active patients. Physical inactivity was associated with greater risk of all-cause death (hazard ratio [HR] 2.01, confidence interval [CI] 1.47 to 3.00; p <0.001) and cardiac death (HR 2.01, CI 1.28 to 3.17; p = 0.002) but no significant difference in HF hospitalization (p = 0.548). Modest exercise (1 to 89 min/week) was associated with a significant reduction in the rate of death (p = 0.003) and cardiac death (p = 0.050). Independent of exercise duration and baseline covariates, television screen time (>4 vs <2 h/day) was associated with all-cause death (HR 1.65, CI 1.10 to 2.48; p = 0.016; incremental chi-square = 6.05; p = 0.049). In conclusion, in patients with symptomatic chronic HF, physical inactivity is associated with higher all-cause and cardiac mortality. Failure to exercise and television screen time are additive in their effects on mortality. Even modest exercise was associated with survival benefit.
Impact of dietary sodium restriction on heart failure outcomes
2016, JACC: Heart Failure
Citation Excerpt :
HART assessed the impact of self-management counseling versus education alone on the primary outcome of death or HF hospitalization in patients with symptomatic HF. Details of the intervention, patient enrollment, eligibility, and results of the main trial were reported elsewhere (10,11). The study enrolled from 10 centers in the Chicago, Illinois metropolitan area and the behavioral intervention was conducted by Rush University Medical Center.
This study sought to evaluate the impact of sodium restriction on heart failure (HF) outcomes.
Although sodium restriction is advised for patients with HF, data on sodium restriction and HF outcomes are inconsistent.
We analyzed data from the multihospital HF Adherence and Retention Trial, which enrolled 902 New York Heart Association functional class II/III HF patients and followed them up for a median of 36 months. Sodium intake was serially assessed by a food frequency questionnaire. Based on the mean daily sodium intake prior to the first event of death or HF hospitalization, patients were classified into sodium restricted (<2,500 mg/d) and unrestricted (≥2,500 mg/d) groups. Study groups were propensity score matched according to plausible baseline confounders. The primary outcome was a composite of death or HF hospitalization. The secondary outcomes were cardiac death and HF hospitalization.
Sodium intake data were available for 833 subjects (145 sodium restricted, 688 sodium unrestricted), of whom 260 were propensity matched into sodium restricted (n = 130) and sodium unrestricted (n = 130) groups. Sodium restriction was associated with significantly higher risk of death or HF hospitalization (42.3% vs. 26.2%; hazard ratio [HR]: 1.85; 95% confidence interval [CI]: 1.21 to 2.84; p = 0.004), derived from an increase in the rate of HF hospitalization (32.3% vs. 20.0%; HR: 1.82; 95% CI: 1.11 to 2.96; p = 0.015) and a nonsignificant increase in the rate of cardiac death (HR: 1.62; 95% CI: 0.70 to 3.73; p = 0.257) and all-cause mortality (p = 0.074). Exploratory subgroup analyses suggested that sodium restriction was associated with increased risk of death or HF hospitalization in patients not receiving angiotensin-converting enzyme inhibitor or angiotensin receptor blocker (HR: 5.78; 95% CI: 1.93 to 17.27; p = 0.002).
In symptomatic patients with chronic HF, sodium restriction may have a detrimental impact on outcome. A randomized clinical trial is needed to definitively address the role of sodium restriction in HF management. (A Self-management Intervention for Mild to Moderate Heart Failure [HART]; NCT00018005)
Building skill in heart failure self-care among community dwelling older adults: Results of a pilot study
2014, Patient Education and Counseling
Most of the day-to-day care for heart failure (HF) is done by the patient at home and requires skill in self-care. In this randomized controlled trial (RCT) we tested the efficacy of a community-based skill-building intervention on HF self-care, knowledge and health-related quality of life (HRQL) at 1- and 3-months.
An ethnically diverse sample (n = 75) of patients with HF (53% female; 32% Hispanic, 27% Black; mean age 69.9 ± 10 years) was randomized to the intervention group (IG) or a wait-list control group (CG). The protocol intervention focused on tactical and situational HF self-care skill development delivered by lay health educators in community senior centers. Data were analyzed using mixed (between–within subjects) ANOVA.
There was a significant improvement in self-care maintenance [F(2, 47) = 3.42, p = .04, (Cohen's f = .38)], self-care management [F(2, 41) = 4.10, p = .02, (Cohen's f = .45) and HF knowledge [F(2, 53) = 8.00, p = .001 (Cohen's f = .54)] in the IG compared to the CG.
The skill-building intervention improved self-care and knowledge but not HRQL in this community-dwelling sample.
Delivering an intervention in a community setting using lay health educators provides an alternative to clinic- or home-based teaching that may be useful across diverse populations and geographically varied settings.
Comparison of predictors of heart failure-related hospitalization or death in patients with versus without preserved left ventricular ejection fraction
2013, American Journal of Cardiology
Citation Excerpt :
HART was a single-center, multiple-hospital, partially blinded, randomized controlled behavioral trial that was based in the Chicago metropolitan area. HART was designed to assess the impact of self-management counseling versus education alone on the composite primary outcome of death or HF hospitalizations in patients with HFrEF or those with HFpEF.1,2 HART enrolled a total of 902 patients.
Heart failure with preserved ejection fraction (HFpEF) is recognized as a major cause of cardiovascular morbidity and mortality. An ability to identify patients with HFpEF who are at increased risk for adverse outcomes can facilitate their more careful management. We studied the patients having heart failure (HF) using data from the Heart Failure Adherence and Retention Trial (HART). HART enrolled 902 patients in the New York Heart Association (NYHA) class II or III who had been recently hospitalized for HF to study the impact of self-management counseling on the primary outcome of death or HF hospitalization. In HART, 208 patients had HFpEF and 692 had HF with reduced ejection fraction (HFrEF) and were followed for a median of 1,080 days. Two final multivariate models were developed. In patients having HFpEF, predictors of primary outcome were male gender (odds ratio [OR] 3.45, p = 0.004), NYHA class III (OR 3.05, p = 0.008), distance covered on a 6-minute walk test (6-MWT) of <620 feet (OR 2.81, p = 0.013), and <80% adherence to prescribed medications (OR 2.61, p = 0.018). In patients having HFrEF, the predictors were being on diuretics (OR 3.06, p = 0.001), having ≥3 co-morbidities (OR 2.11, p = 0.0001), distance covered on a 6-MWT of <620 feet (OR 1.94, p = 0.001), NYHA class III (OR 1.90, p = 0.001), and age >65 years (OR 1.63, p = 0.01). In conclusion, indicators of functional status (6-MWT and NYHA class) were common to both patients with HFpEF and those with HFrEF, whereas gender and adherence to prescribed therapy were unique to patients having HFpEF in predicting death or HF hospitalization.
Effects of exercise training for heart failure with preserved ejection fraction: A systematic review and meta-analysis of comparative studies
2012, International Journal of Cardiology
We conducted a systematic review to assess the effect of exercise training in patients with heart failure with preserved ejection fraction (HFPEF).
A number of electronic databases were searched up to November 2011 to identify comparative studies of exercise training in HFPEF. Where possible, outcome data from included studies were pooled using meta-analysis.
Three randomised controlled trials, one non-randomised controlled trial and one pre-post study were included, for a total of 228 individuals. The combined duration of exercise programmes and follow-up ranged from 12 to 24 weeks. No deaths, hospital admissions or serious adverse events were observed during or immediately following exercise training. Compared to control, the change in exercise capacity at follow-up was higher with exercise training (between group mean difference: 3.0 ml/kg/min, 95% CI: 2.4 to 2.6). In the four studies, that reported the Minnesota Living with Heart Failure questionnaire, there was evidence of a larger gain in health-related quality of life with exercise training (7.3 units, 3.3 to 11.4). The largest study showed some evidence of improvement in the E/E′ ratio with exercise training, but this was not confirmed in the other studies (overall − 0.9, − 3.8 to 2.0); E/A ratios were not changed.
Exercise training for patients with HFPEF confers benefit in terms of enhancements in exercise capacity and health-related quality of life and appears to be safe. The impact on diastolic function remains unclear. Further trials should provide data on long term effects, prognostic relevance and cost-effectiveness.
Depression predicts repeated heart failure hospitalizations
2012, Journal of Cardiac Failure
Management of depression, if it is independently associated with repeated hospitalizations for heart failure (HF), offers promise as a viable and cost-effective strategy to improve health outcomes and reduce health care costs for HF. The objective of this study was to assess the association between depression and the number of HF-related hospitalizations in patients with low-to-moderate systolic or diastolic dysfunction, after controlling for illness severity, socioeconomic factors, physician adherence to evidence-based medications, patient adherence to HF drug therapy, and patient adherence to salt restrictions.
The Heart Failure Adherence and Retention Trial (HART) was a randomized behavioral trial to evaluate whether patient self-management skills coupled with HF education improved patient outcomes. Depression was measured at baseline with the Geriatric Depression Scale (GDS). The number of hospitalizations was analyzed with a negative binomial regression model that included an offset term to account for the differential duration of follow-up for individual subjects. The average unadjusted number of hospitalizations per year was 0.40 in the depressed group (GDS ≥10) and 0.33 in the nondepressed group (GDS <10). Depression was a strong predictor (incident rate ratio 1.45; P = .006) after adjusting for physician adherence to evidence-based medication use, patient adherence to HF drug therapy, patient adherence to salt restriction, illness severity, HF severity (6-minute walk <620 feet), and socioeconomic factors.
Depression is a strong psychosocial predictor of repeated hospitalizations for HF. Compared with nondepressed individuals, those with depression were hospitalized for HF 1.45 times more often, even after controlling for physician adherence to evidence-based medications and patient adherence to HF drug therapy and salt restrictions. This finding suggests that clinicians should screen for depression early in the course of HF management.

View all citing articles on Scopus

: Support for HART from HL065547. Clinical Trials Registration NCT00018005.

^d: For a list of HART Investigators, see Appendix A.

View full text

Trial DesignThe Heart Failure Adherence and Retention Trial (HART): Design and rationale

Background

Trial Design

Conclusions

Section snippets

Aims and hypotheses

Trial organization

Discussion

J Am Coll Cardiol

J Am Coll Cardiol

Am Heart J

Int J Cardiol

J Am Coll Cardiol

Patient Educ Couns

Heart Lung

Am Heart J

Am Heart J

Cardiol Clin

J Psychiat Res

Soc Sci Med

Contemp Clin Trials

Shattuck lecture: cardiovascular medicine at the turn of the millennium: triumphs, concerns, and opportunities

N Engl J Med

Trends in heart failure incidence and survival in a community-based population

JAMA

Acutely decompensated heart failure: opportunities to improve care and outcomes in the emergency department

Rev Cardiovasc Med

Heart disease and stroke statistics—2007 update. A report from the American Heart Association Statistics Committee and Stroke Statistics Subcommittee

Circulation

Medical progress: heart failure

New Engl J Med

Elements of nonpharmacologic interventions that prevent progression of heart failure: a meta-analysis

Congest Heart Fail

A systematic review and meta-analysis of studies comparing readmission rates and mortality rates in patients with heart failure

Arch Intern Med

Comprehensive discharge planning with postdischarge support for older patients with congestive heart failure

JAMA

Trial Design
The Heart Failure Adherence and Retention Trial (HART): Design and rationale