The Effect of Palliative Care Training on Symptom Management and Quality of Life in Chronic Heart Failure
14 mars 2022 mis à jour par: Gülşah Çamcı, Marmara University
The Effect of Palliative Care Training on Symptom Management, Rehospitalization and Quality of Life in Chronic Heart Failure: : A Randomized Controlled Trial
Palliative care is of great importance because of poor quality of life and high mortality risk in advanced heart failure.
This study was planned as a randomized controlled trial to determine the effect of palliative care training on symptom management, rehospitalization, and quality of life among patients with heart failure.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
Patients were informed about the research and written informed consent was obtained.
Data were collected by face-to-face interviews within two days before discharge.
Patient information form and scales were applied to Patients in the intervention and control groups.
Patients in the intervention group were received education after filling the forms.
The training was given one by one at the hospital.
One or two relatives of patients were included in the training.
The patient was comfortably seated, and the room door was closed, face to face interaction was conducted.
The patient and his/her relatives were allowed to ask questions during the training.
The patient in the intervention group received at least 45 minutes of data collection from a case because of detailed training.
It took about 15 minutes to collect data from a patient in the control group.
In some patients, the training program was divided to be clearer.
The patients were traced by telephone at the first, third, and sixth months after discharge.
The investigator's phone number was presented to the patients and they were told that they could call at any time.
Continuous communication was ensured by giving the educator's phone number to the patients.
The training was repeated by contacting the phone.
The intervention group was retrained about symptoms they experienced during their telephone interview.
The training was given to the experimental group as planned.
No modifications/changes were made to the intervention during the study.
Special notes were taken for each patient.
The effect of the education given on the quality of life and symptom management was evaluated with questionnaires.
The intervention was adhered to as planned.
Type d'étude
Interventionnel
Inscription (Réel)
84
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
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Istanbul, Turquie
- Marmara University
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Istanbul, Turquie
- Marmara U.
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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 86 ans (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
- 18-year-old or over,
- Class III and IV heart failure patients according to New York Heart Association (NYHA) classification,
- Patients without any communication problem to prevent participation in the research [loss of hearing, visual impairment, lack of understanding/speaking in Turkish], can be contacted by telephone, are literate.
- The patients who were diagnosed with heart failure at least six months ago accepted to participate voluntarily were also included in the study.
Exclusion Criteria:
- Patients who wish to quit their study voluntarily during the study period and patients who died or worsened during the study period.
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: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: palliative care education
The patients in the intervention group were presented palliative care training in addition to their usual care.
The training period lasts at least 45 minutes.
After the training, patients were given the book 'Palliative Care in Heart Failure'.
In this training, patients were informed about heart failure and pharmacological and non-pharmacological methods for symptoms such as dyspnea, pain, constipation, depression, edema, tiredness, nausea.
The patients were followed up by telephone at the first, third, and sixth months after discharge.
The patient's symptoms and quality of life were re-evaluated in telephone follow-up.
During the follow-up period, the patient's training related to symptoms was repeated.
The patients were referred to the physician for the symptoms and problems which they experienced in the house.
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The patients in the intervention group were presented palliative care training in addition to their usual care
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Aucune intervention: usual care
Firstly, the usual care provided to patients was described.
It was determined that patients were not given regular and comprehensive training on heart failure, and no training was given on palliative care.
Written educational material was not given to the patients.
Patients were not followed up after discharge.
Palliative care was not discussed with patients and their relatives.
Also, they were not asked about their preferences.
In usual care, Heart failure patients received medical treatment for their symptoms during hospitalization.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Edmonton symptom assessment scale
Délai: six months
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ESAS consists of 10 symptoms as tiredness, pain, feeling of well-being, nausea, depression, anxiety, lack of appetite, drowsiness, shortness of breath, and others.
Each symptom is scored between 0 and 10.
While Zero points indicate no symptoms, 10 points are severe of symptoms.
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six months
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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LVD-36-left ventricular dysfunction questionnaire
Délai: six months
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The questionnaire consists of 36 questions and the questions are answered as true or false.
The correct answers are collected and indicated as the total percentage.
The score is 0-100.
High scores indicate poor quality of life.
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six months
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Gülşah Çamcı, PhD, Marmara University
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 (Réel)
1 janvier 2017
Achèvement primaire (Réel)
31 décembre 2017
Achèvement de l'étude (Réel)
10 novembre 2018
Dates d'inscription aux études
Première soumission
4 mars 2022
Première soumission répondant aux critères de contrôle qualité
14 mars 2022
Première publication (Réel)
17 mars 2022
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
17 mars 2022
Dernière mise à jour soumise répondant aux critères de contrôle qualité
14 mars 2022
Dernière vérification
1 mars 2022
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- MU-SBF-IHH-GC-01
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Non
Description du régime IPD
After the article is published, the results of the study will be shared.
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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 .