The TElemonitoring in the Management of Heart Failure (TEMA-HF) 1 Long-term Follow-up Study

NCT ID: NCT03171038

Last Updated: 2017-06-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-01

Study Completion Date

2015-08-01

Brief Summary

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TEMA-HF 1 Long-Term Follow-up study is a follow-up study of TEMA-HF 1. It assessed the long-term impact of a 6-months telemonitoring program in chronic heart failure patients.

Detailed Description

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The telemonitoring (TM) group patients received a 6-months TM program, followed by standard heart failure care until the long-term follow-up evaluation.

The usual care (UC) patients received ususal care during the first six months, followed by standard heart failure care until the long-term follow-up evaluation.

Conditions

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Telemonitoring in Coronary Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospective, multi-center randomized controlled trial
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Telemonitoring group

6 months of telemonitoring (t0-t1), followed by usual care up until common long-term stopping date (t1-t2).

Group Type EXPERIMENTAL

Telemonitoring

Intervention Type OTHER

Usual care group

Usual care from t0 up until the common stopping date (t2).

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Telemonitoring

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Chronic heart failure patients
* Treated for heart failure according to current guidelines
* ≥ 18 years of age
* Able to provide informed consent

Exclusion Criteria

* Reversible forms of acute heart failure (myocarditis)
* Presence of severe aortic stenosis
* Previous residency in a nursing home
* Inclusion in a cardiac rehabilitation program on discharge
* Chronic kidney disease stage ≥ 4
* Planned dialysis in the next six months
* Life expectancy \< 1 year due to non-heart failure related reasons
* Severe chronic obstructive pulmonary disease, GOLD ≥ III
* Cognitive and/or mental problems interfering with the performance of daily measurements and data transmission
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hasselt University

OTHER

Sponsor Role lead

Responsible Party

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prof. dr. Paul Dendale

Prof. dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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Frederix I, Vanderlinden L, Verboven AS, Welten M, Wouters D, De Keulenaer G, Ector B, Elegeert I, Troisfontaines P, Weytjens C, Mullens W, Dendale P. Long-term impact of a six-month telemedical care programme on mortality, heart failure readmissions and healthcare costs in patients with chronic heart failure. J Telemed Telecare. 2019 Jun;25(5):286-293. doi: 10.1177/1357633X18774632. Epub 2018 May 10.

Reference Type DERIVED
PMID: 29742959 (View on PubMed)

Other Identifiers

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Jessa Hospital

Identifier Type: -

Identifier Source: org_study_id

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