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

Primary Purpose

Heart Failure, End of Life

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
palliative care educatiom
Sponsored by
Marmara University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Heart Failure focused on measuring heart failure, palliative care, rehospitalization, symptom burden, quality of life

Eligibility Criteria

18 Years - 86 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Marmara U.
  • Marmara University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

palliative care education

usual care

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Edmonton symptom assessment scale
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.

Secondary Outcome Measures

LVD-36-left ventricular dysfunction questionnaire
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.

Full Information

First Posted
March 4, 2022
Last Updated
March 14, 2022
Sponsor
Marmara University
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1. Study Identification

Unique Protocol Identification Number
NCT05285163
Brief Title
The Effect of Palliative Care Training on Symptom Management and Quality of Life in Chronic Heart Failure
Official Title
The Effect of Palliative Care Training on Symptom Management, Rehospitalization and Quality of Life in Chronic Heart Failure: : A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2017 (Actual)
Primary Completion Date
December 31, 2017 (Actual)
Study Completion Date
November 10, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Marmara University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, End of Life
Keywords
heart failure, palliative care, rehospitalization, symptom burden, quality of life

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The control group took usual care and the intervention group took both usual care and palliative care.
Masking
Participant
Masking Description
The patients were distributed with the minimization method of covariate-oriented randomization. According to NYHA (class III, IV), sex (male and female), and the number of hospitalizations (≤3 and ≥4) within one year, the patients were randomly appointed to the control and intervention groups. Thus, the patients in the intervention and control groups were distributed as homogeneous.
Allocation
Randomized
Enrollment
84 (Actual)

8. Arms, Groups, and Interventions

Arm Title
palliative care education
Arm Type
Experimental
Arm Description
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.
Arm Title
usual care
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
palliative care educatiom
Intervention Description
The patients in the intervention group were presented palliative care training in addition to their usual care
Primary Outcome Measure Information:
Title
Edmonton symptom assessment scale
Description
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.
Time Frame
six months
Secondary Outcome Measure Information:
Title
LVD-36-left ventricular dysfunction questionnaire
Description
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.
Time Frame
six months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
86 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gülşah Çamcı, PhD
Organizational Affiliation
Marmara University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Marmara U.
City
Istanbul
Country
Turkey
Facility Name
Marmara University
City
Istanbul
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
After the article is published, the results of the study will be shared.

Learn more about this trial

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

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