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

NCT ID: NCT05285163

Last Updated: 2022-03-17

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

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-01

Study Completion Date

2018-11-10

Brief Summary

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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

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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.

Conditions

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Heart Failure End of Life

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The control group took usual care and the intervention group took both usual care and palliative care.
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants
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.

Study Groups

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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.

Group Type EXPERIMENTAL

palliative care educatiom

Intervention Type BEHAVIORAL

The patients in the intervention group were presented palliative care training in addition to their usual care

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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palliative care educatiom

The patients in the intervention group were presented palliative care training in addition to their usual care

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

86 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Marmara University

OTHER

Sponsor Role lead

Responsible Party

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Gülşah Çamcı

Assistant Prof

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gülşah Çamcı, PhD

Role: PRINCIPAL_INVESTIGATOR

Marmara University

Locations

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Marmara U.

Istanbul, , Turkey (Türkiye)

Site Status

Marmara University

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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MU-SBF-IHH-GC-01

Identifier Type: -

Identifier Source: org_study_id

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