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Heart at Home- a Self-care Study

15 septembre 2014 mis à jour par: VTT Technical Research Centre of Finland

Heart at Home- Remote Patient Monitoring in the Care of Heart Failure Patients

In the study benefits of using mobile phone assisted remote patient monitoring including self-measurements of blood pressure, heart rate and weight as well as monitoring of personal health status are investigated in the care of heart failure patients.

Aperçu de l'étude

Statut

Complété

Les conditions

Type d'étude

Interventionnel

Inscription (Réel)

94

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

      • Espoo, Finlande
        • VTT Technical Research Centre of Finland

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans à 90 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

  • diagnosis of systolic heart failure
  • NYHA (New York Heart Association) classification > 1
  • left ventricular ejection fraction ≤ 35%
  • need for a regular control visit
  • time from the last visit no longer than 6 months

Exclusion Criteria:

  • Patients who were known to enter a major medical operation
  • severe comorbidity,
  • participation in other clinical trial during last three months-
  • poor compliance in terms of familiarity with mobile phone

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Comparateur actif: Telemonitoring assisted self-care
Telemonitoring group was given a home-care package including a weight scale, a blood pressure meter, a mobile phone and self-care instructions. The measurements taken at home to be uploaded were: diastolic and systolic blood pressure, pulse, body weight and an assessment of symptoms. The symptom assessment concerned the patient's feelings of dizziness, dyspnea, palpitation, weakness and, oedema. Patients were also asked to evaluate their overall condition- whether their condition had deteriorated, improved or remained unchanged. The patients were advised to carry out and report the measurements together with the self-assessment once a week. The responsible nurse followed patients' status and the data once a week or more frequently if needed. Based on the reported measurements, the nurse could invite the patient for a control visit. In case a patient did not make self-measurements as planned , the nurse contacted the patient and reminded him/ her to continue with monitoring.
Telemonitoring group was given a home-care package including a weight scale, a blood pressure meter, a mobile phone and self-care instructions. The measurements taken at home to be uploaded were: diastolic and systolic blood pressure, pulse, body weight and an assessment of symptoms. The symptom assessment concerned the patient's feelings of dizziness, dyspnea, palpitation, weakness and, oedema. Patients were also asked to evaluate their overall condition- whether their condition had deteriorated, improved or remained unchanged. The patients were advised to carry out and report the measurements together with the self-assessment once a week. The responsible nurse followed patients' status and the data once a week or more frequently if needed. Based on the reported measurements, the nurse could invite the patient for a control visit. In case a patient did not make self-measurements as planned , the nurse contacted the patient and reminded him/ her to continue with monitoring
Aucune intervention: Control group
Control group received usual care that includes multidisciplinary care approach in which patients receive guidance and support for self-care. In the care of heart failure (HF) patients, the cardiac team plays a central role in monitoring and interpreting patient symptoms, optimizing medication and providing education. The cardiac team consists of two physicians, one specialized heart failure nurse and a physiotherapist who helps after a hospitalization period. As part of the care process, patients capable of carrying out self-care are identified and they are encouraged to regularly measure their blood pressure, heart rate and weight at home. So far, the information exchange between heart failure patients and care personnel has taken place during patients' visits to the clinic and by telephone. Systematic collection and exploitation of the self-measurement data has been difficult, since it depends on the patient's own activity

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Number of HF-related Hospital Days
Délai: From baseline until the end of the study at six months
Number of heart failure related hospital days
From baseline until the end of the study at six months

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Death
Délai: From baseline until the end of the study at six months
Death from any cause
From baseline until the end of the study at six months
Heart Transplant
Délai: From baseline until the end of the study at six months
Heart transplant operation or listing for transplant operation
From baseline until the end of the study at six months
P-proBNP
Délai: From baseline until the end of the study at six months
Change in plasma concentration of brain natriuretic peptide propeptide from baseline to the end of the study.
From baseline until the end of the study at six months
EHFSBS (European Heart Failure Self-Care Behaviour Scale ) Scores
Délai: From baseline until the end of the study at six months
Change in self-care behaviour measured by the European Heart Failure Self-Care Behaviour Scale (EHFSBS). EHFSBS is a 12-item self-administered questionnaire specifically designed and tested for heart failure patients including statements on self-care behaviour essential in the care of HF. The statements are scored from one to five. The lower the score, the better the performance in self-care. The summary score is analysed.
From baseline until the end of the study at six months
Left Ventricular Ejection Fraction
Délai: From baseline until the end of the study at six months
Change in left ventricular ejection fraction from baseline until the end of the study
From baseline until the end of the study at six months
Utilization of Health Care Resources
Délai: From baseline until the end of the study at six months
Number of visits to nurse's reception
From baseline until the end of the study at six months

Autres mesures de résultats

Mesure des résultats
Description de la mesure
Délai
Plasma Concentrations of Creatinine, Natrium, and Potassium From the Baseline to the End of the Study
Délai: From baseline to the end of the study at six months
Change in plasma concentrations of creatinine, natrium, and potassium
From baseline to the end of the study at six months

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 octobre 2010

Achèvement primaire (Réel)

1 mars 2012

Achèvement de l'étude (Réel)

1 juin 2012

Dates d'inscription aux études

Première soumission

20 décembre 2012

Première soumission répondant aux critères de contrôle qualité

30 décembre 2012

Première publication (Estimation)

3 janvier 2013

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

17 septembre 2014

Dernière mise à jour soumise répondant aux critères de contrôle qualité

15 septembre 2014

Dernière vérification

1 septembre 2014

Plus d'information

Termes liés à cette étude

Autres numéros d'identification d'étude

  • HUSHAH

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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