Randomized Trial of Phone Intervention in Chronic Heart Failure - DIAL

Jul 25, 2010
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Author/Summarized by Author:
Dharam J. Kumbhani, MD, SM, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Date Presented:
01/01/2002
Date Published:
01/01/2010
Date Updated:
07/25/2010
Original Posted Date:
07/25/2010
References

Description:

This was a randomized trial comparing a centralized telephone-based intervention in addition to standard physician care for heart failure, with standard physician monitoring.

Hypothesis:

The addition of telephone intervention to standard physician care for heart failure would result in a decrease in the composite of all-cause mortality and hospitalization for heart failure.

Study Design

  • Randomized
  • Parallel

Patients Screened: 2,385
Patients Enrolled: 1,518
Mean Follow Up: 12 months; extended follow-up additional 3 years
Mean Patient Age: 65 years
Female: 29%

Patient Populations:

  • Age ≥18 years
  • Chronic heart failure ≥3 months
  • Clinical stability for ≥2 months

Exclusions:

  • No telephone contact available
  • Acute coronary syndrome in prior 3 months
  • <1 year expected survival
  • Congenital cardiomyopathy

Primary Endpoints:

  • Death or heart failure hospitalization

Secondary Endpoints:

  • Death
  • Hospitalization for heart failure
  • All-cause admissions
  • Cardiovascular admissions

Drug/Procedures Used:

Standard physician care compared with nurse-based telephone intervention was used, in addition to standard physician care for heart failure. The telephone intervention included education, counseling, and monitoring for symptom progression, therapy compliance, weight control, physical activity, edema progression, and diet compliance, and included nurse modification of the diuretic regimen dosing as needed.

Concomitant Medications:

Diuretics (83%), digoxin (47%), spironolactone (32%), beta-blockers (62%), and angiotensin-converting enzyme inhibitors (79%)

Principal Findings:

The composite endpoint of death or heart failure hospitalization at 1 year in the telephone intervention arm was lower than the standard physician care arm (26.3% vs. 31%, relative risk [RR] 0.80, 95% confidence interval [CI] 0.66-0.97, p = 0.026). The composite endpoint was driven primarily by a reduction in heart failure hospitalizations (16.8% vs. 22.3%, RR 0.71, p = 0.005), as no difference in mortality was observed (RR 0.95, p = 0.69). All-cause admissions were reduced 15% (p = 0.05) and cardiovascular admissions were reduced 24% (p = 0.006).

Subgroup analysis of the primary endpoint by Killip class was homogenous (RR 0.76 in Killip I/II and RR 0.67 in Killip III/IV). At the end of the trial, significantly more patients in the intervention group compared with the control group were taking beta-blockers (59.2% vs. 51.6%, p = 0.003), spironolactone (27.2% vs. 22.6%, p = 0.03), digoxin (33.4% vs. 28.6%, p = 0.04), and furosemide (77.3% vs. 70.5%, p = 0.007).

At 3 years after trial completion, the incidence of death or heart failure hospitalization was still lower in the telephone intervention arm (55.7% vs. 57.5%, p = 0.05), once again due to a reduction in readmissions (28.5% vs. 35.1%, p = 0.0004).

 

Interpretation:

Use of a centralized nurse-based telephone intervention for education, counseling, and monitoring, in addition to standard physician care of heart failure, resulted in a reduction in the composite of death and heart failure hospitalizations, although the result was driven primarily by heart failure hospitalizations. An important unanswered question is whether the additional cost of the intervention would be offset by a reduction in hospitalizations. Further exploration into what component of the intervention accounted for the reduction in heart failure hospitalizations and what behaviors were changed (diet, compliance, dosing) will add further insight into the benefit of the therapy.

Intriguingly, the salutary effects of telephone intervention were still noted 3 years after the trial (and telephone intervention) was stopped. This intervention could thus be a good complement to existing strategies in patients with congestive heart failure, and deserves further study.

References:

Ferrante D, Varini S, Macchia A, et al. Long-term results after a telephone intervention in chronic heart failure: DIAL (Randomized Trial of Phone Intervention in Chronic Heart Failure) follow-up. J Am Coll Cardiol 2010;56:372-8. 

Presented at the American Heart Association Annual Scientific Sessions, November 2002, late breaking clinical trials.

Keywords: Risk, Digoxin, Diuretics, Heart Failure, Motor Activity, Counseling, Edema, Diet, Confidence Intervals, Spironolactone, Furosemide


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