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The Effect of Palliative Care Training on Symptom Management and Quality of Life in Chronic Heart Failure

14 marzo 2022 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

84

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

      • Istanbul, Tacchino
        • Marmara University
      • Istanbul, Tacchino
        • Marmara U.

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 86 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Prevenzione
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
The patients in the intervention group were presented palliative care training in addition to their usual care
Nessun intervento: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Edmonton symptom assessment scale
Lasso di tempo: six months
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.
six months

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
LVD-36-left ventricular dysfunction questionnaire
Lasso di tempo: six months
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.
six months

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Investigatore principale: Gülşah Çamcı, PhD, Marmara University

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 gennaio 2017

Completamento primario (Effettivo)

31 dicembre 2017

Completamento dello studio (Effettivo)

10 novembre 2018

Date di iscrizione allo studio

Primo inviato

4 marzo 2022

Primo inviato che soddisfa i criteri di controllo qualità

14 marzo 2022

Primo Inserito (Effettivo)

17 marzo 2022

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

17 marzo 2022

Ultimo aggiornamento inviato che soddisfa i criteri QC

14 marzo 2022

Ultimo verificato

1 marzo 2022

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • MU-SBF-IHH-GC-01

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

No

Descrizione del piano IPD

After the article is published, the results of the study will be shared.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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