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

NCT05285163 | Completed

• 1 other identifier: MU-SBF-IHH-GC-01
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 2

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.

Conditions

Heart Failure; End of Life

Keywords

heart failure; palliative care; rehospitalization; symptom burden; quality of life

Outcome Measures

Primary Outcomes (1)

• 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.

  six months

Secondary Outcomes (1)

• LVD-36-left ventricular dysfunction questionnaire

  six months

Study Arms (2)

palliative care education

EXPERIMENTAL

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.

Behavioral: palliative care educatiom

usual care

NO INTERVENTION

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.

Interventions

palliative care educatiom BEHAVIORAL

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

palliative care education

Eligibility Criteria

• Age: 18 Years - 86 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients who wish to quit their study voluntarily during the study period and patients who died or worsened during the study period.

Sponsors & Collaborators

• Marmara University: lead

Study Sites (2)

Marmara U.

Istanbul, Turkey (Türkiye)

Location

Marmara University

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Heart Failure; Death

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Gülşah Çamcı, PhD

  Marmara University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Prof

Model Details: The control group took usual care and the intervention group took both usual care and palliative care.

Study Record Dates

• First Submitted: March 4, 2022
• First Posted: March 17, 2022
• Study Start: January 1, 2017
• Primary Completion: December 31, 2017
• Study Completion: November 10, 2018
• Last Updated: March 17, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)