Clinical Trial Methods and DesignRandomized Trial of Telephone Intervention in Chronic Heart Failure (DIAL): Study design and preliminary observations*,**
Section snippets
Objectives
The primary objective of this study is to determine the effect of frequent telephone follow-up (telephone monitoring) in outpatients with chronic heart failure as compared with the usual follow-up (control) on the combined endpoint of all-cause mortality or hospitalization for worsening heart failure.
The secondary objectives refer to the impact of this intervention on the following:
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Total mortality, all-cause hospitalization, and hospitalization for worsening heart failure
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Cardiovascular
Design
The Randomized Trial of Telephone Intervention in Chronic Heart Failure (DIAL) is a randomized controlled open trial to compare frequent telephone follow-up intervention vs. control. Outcomes are evaluated in a blind manner by a central endpoint committee.
Statistical analysis and assessment
All randomized patients will be included in an efficacy and safety analysis according to the randomization group, with an intention to treat principle, in a 2-sided way. All confirmatory analyses will be based on this population. All patients will be followed up until the end of the study. An independent Events Review Committee will assess and classify the primary end point events in a centralized and blinded manner.
Discussion
As with other chronic disabling diseases, appropriate medical follow-up of heart failure patients requires more comprehensive strategies to enhance quality of life, reduce morbidity, and improve prognosis.
Recent advances in heart failure therapy have resulted in higher survival; however, these therapies are not curative, and thus the overall burden of the heart failure syndrome remains unchanged, or even growing.
Although there is strong evidence available regarding the favorable effect of ACE
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Cited by (62)
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2015, Journal of Cardiac FailureTowards a Personal Health Management Assistant
2010, Journal of Biomedical InformaticsLong-term results after a telephone intervention in chronic heart failure: DIAL (Randomized trial of phone intervention in chronic heart failure) follow-up
2010, Journal of the American College of CardiologyReply
2010, Journal of the American College of CardiologyDIAL Trial Not Included in a Review of Health Failure Management Programs
2010, Journal of the American College of Cardiology
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