Clinical trial NCT05285163: 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
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
End of Life
Keywords: heart failure
palliative care
rehospitalization
symptom burden
quality of life
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2022-03-17
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 86
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The control group took usual care and the intervention group took both usual care and palliative care.
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Edmonton symptom assessment scale
timeFrame: six months
Secondary outcomes:
measure: LVD-36-left ventricular dysfunction questionnaire
timeFrame: six months
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Marmara U.
city: Istanbul
country: Turkey
facility: Marmara University
Study officials:
affiliation: Marmara University
name: Gülşah Çamcı, PhD
role: PRINCIPAL_INVESTIGATOR
References: