The feasibility and acceptability of an early tele-palliative care intervention to improve quality of life in heart failure patients in Iran: A protocol for a randomized controlled trial
Background: Heart failure (HF) has become a global health problem that has affected the quality of life of millions of people. One approach to improving patients’ quality of life (QoL) with chronic diseases such as HF is palliative care. In Iran, the bulk of palliative care research is directed to p...
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Format: | Article |
Language: | English |
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Elsevier
2023-06-01
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Series: | Contemporary Clinical Trials Communications |
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Online Access: | http://www.sciencedirect.com/science/article/pii/S2451865423000601 |
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author | Arvin Mirshahi Shahrzad Ghiasvandian Meysam Khoshavi Seyed Mohammad Riahi Ali Khanipour-Kencha Marie Bakitas J. Nicholas Dionne-Odom Rachel Wells Masoumeh Zakerimoghadam |
author_facet | Arvin Mirshahi Shahrzad Ghiasvandian Meysam Khoshavi Seyed Mohammad Riahi Ali Khanipour-Kencha Marie Bakitas J. Nicholas Dionne-Odom Rachel Wells Masoumeh Zakerimoghadam |
author_sort | Arvin Mirshahi |
collection | DOAJ |
description | Background: Heart failure (HF) has become a global health problem that has affected the quality of life of millions of people. One approach to improving patients’ quality of life (QoL) with chronic diseases such as HF is palliative care. In Iran, the bulk of palliative care research is directed to patients with cancer, with the primary focus on the physical aspect rather than the psychosocial and spiritual aspects of palliative care. To address this gap, this study aims to determine the feasibility and acceptability of this early tele-palliative care intervention to improve quality of life in heart failure patients in Iran. Methods: The early tele-palliative care versus usual care study is designed as a single-centre, randomised, feasibility trial of 50 patients with heart failure aged 18 to 65 and clinician-determined New York Heart Association class II/III or American College of Cardiology stage B/C HF, recruited in Imam Khomeini Hospital Complex, Tehran, Iran. This intervention contains 6 weekly educational webinars and concurrent WhatsApp® group activities. Program feasibility and acceptability will be assessed by measuring the recruitment, attrition, and questionnaire completion rates; satisfaction and attitudes about the intervention will be measured via a telephone-based interviews. Secondary outcomes of Qol, mood status and number of emergency department visits will be measured with validated instruments. Participants in both groups will be followed up for 6 weeks, and the measures will be re-administered. Appropriate statistical tests will be used to analyse the data. Conclusion: This is the first early tele-palliative care intervention designed for heart failure patients in Iran. The intervention has been developed by a multidisciplinary team of academic and clinical professionals with patient stakeholder input to create a rigorous and culturally responsive approach for palliative care delivery for heart failure patients in Iran. Trial registration: IRCT registration number - IRCT20100725004443N29. |
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format | Article |
id | doaj.art-5109dccc8e2941a6b9d1ff1f1e913da7 |
institution | Directory Open Access Journal |
issn | 2451-8654 |
language | English |
last_indexed | 2024-03-13T04:26:48Z |
publishDate | 2023-06-01 |
publisher | Elsevier |
record_format | Article |
series | Contemporary Clinical Trials Communications |
spelling | doaj.art-5109dccc8e2941a6b9d1ff1f1e913da72023-06-20T04:20:15ZengElsevierContemporary Clinical Trials Communications2451-86542023-06-0133101114The feasibility and acceptability of an early tele-palliative care intervention to improve quality of life in heart failure patients in Iran: A protocol for a randomized controlled trialArvin Mirshahi0Shahrzad Ghiasvandian1Meysam Khoshavi2Seyed Mohammad Riahi3Ali Khanipour-Kencha4Marie Bakitas5J. Nicholas Dionne-Odom6Rachel Wells7Masoumeh Zakerimoghadam8Department of Medical-Surgical Nursing, School of Nursing and Midwifery, Tehran University of Medical Sciences, Tehran, Iran; USERN Care (TUMS) Office, School of Nursing and Midwifery, Tehran University of Medical Sciences, Tehran, IranDepartment of Medical-Surgical Nursing, School of Nursing and Midwifery, Tehran University of Medical Sciences, Tehran, IranDepartment of Cardiology, School of Medicine, Imam Khomeini Hospital, Tehran University of Medical Sciences, Tehran, IranSchool of Medicine, Cardiovascular Diseases Research Center, Birjand University of Medical Sciences, Tehran, IranDepartment of Medical-Surgical Nursing, School of Nursing and Midwifery, Tehran University of Medical Sciences, Tehran, Iran; USERN Care (TUMS) Office, School of Nursing and Midwifery, Tehran University of Medical Sciences, Tehran, IranSchool of Nursing, and Department of Medicine, Division of Gerontology, Geriatrics, and Palliative Care, University of Alabama at Birmingham, Birmingham, AL, USASchool of Nursing, University of Alabama at Birmingham (UAB) and UAB Center for Palliative and Supportive Care, USASchool of Nursing, University of Alabama at Birmingham, Birmingham, AL, USADepartment of Medical-Surgical Nursing, School of Nursing and Midwifery, Tehran University of Medical Sciences, Tehran, Iran; Corresponding author. Departments of Medical-Surgical Nursing, School of Nursing and Midwifery, Tehran University of Medical Sciences, Nosrat St., Tohid Sq., Post Code: 14197-33171, Tehran, Iran.Background: Heart failure (HF) has become a global health problem that has affected the quality of life of millions of people. One approach to improving patients’ quality of life (QoL) with chronic diseases such as HF is palliative care. In Iran, the bulk of palliative care research is directed to patients with cancer, with the primary focus on the physical aspect rather than the psychosocial and spiritual aspects of palliative care. To address this gap, this study aims to determine the feasibility and acceptability of this early tele-palliative care intervention to improve quality of life in heart failure patients in Iran. Methods: The early tele-palliative care versus usual care study is designed as a single-centre, randomised, feasibility trial of 50 patients with heart failure aged 18 to 65 and clinician-determined New York Heart Association class II/III or American College of Cardiology stage B/C HF, recruited in Imam Khomeini Hospital Complex, Tehran, Iran. This intervention contains 6 weekly educational webinars and concurrent WhatsApp® group activities. Program feasibility and acceptability will be assessed by measuring the recruitment, attrition, and questionnaire completion rates; satisfaction and attitudes about the intervention will be measured via a telephone-based interviews. Secondary outcomes of Qol, mood status and number of emergency department visits will be measured with validated instruments. Participants in both groups will be followed up for 6 weeks, and the measures will be re-administered. Appropriate statistical tests will be used to analyse the data. Conclusion: This is the first early tele-palliative care intervention designed for heart failure patients in Iran. The intervention has been developed by a multidisciplinary team of academic and clinical professionals with patient stakeholder input to create a rigorous and culturally responsive approach for palliative care delivery for heart failure patients in Iran. Trial registration: IRCT registration number - IRCT20100725004443N29.http://www.sciencedirect.com/science/article/pii/S2451865423000601Palliative careHeart failureTelemedicineClinical trial protocolFeasibility studiesIran |
spellingShingle | Arvin Mirshahi Shahrzad Ghiasvandian Meysam Khoshavi Seyed Mohammad Riahi Ali Khanipour-Kencha Marie Bakitas J. Nicholas Dionne-Odom Rachel Wells Masoumeh Zakerimoghadam The feasibility and acceptability of an early tele-palliative care intervention to improve quality of life in heart failure patients in Iran: A protocol for a randomized controlled trial Contemporary Clinical Trials Communications Palliative care Heart failure Telemedicine Clinical trial protocol Feasibility studies Iran |
title | The feasibility and acceptability of an early tele-palliative care intervention to improve quality of life in heart failure patients in Iran: A protocol for a randomized controlled trial |
title_full | The feasibility and acceptability of an early tele-palliative care intervention to improve quality of life in heart failure patients in Iran: A protocol for a randomized controlled trial |
title_fullStr | The feasibility and acceptability of an early tele-palliative care intervention to improve quality of life in heart failure patients in Iran: A protocol for a randomized controlled trial |
title_full_unstemmed | The feasibility and acceptability of an early tele-palliative care intervention to improve quality of life in heart failure patients in Iran: A protocol for a randomized controlled trial |
title_short | The feasibility and acceptability of an early tele-palliative care intervention to improve quality of life in heart failure patients in Iran: A protocol for a randomized controlled trial |
title_sort | feasibility and acceptability of an early tele palliative care intervention to improve quality of life in heart failure patients in iran a protocol for a randomized controlled trial |
topic | Palliative care Heart failure Telemedicine Clinical trial protocol Feasibility studies Iran |
url | http://www.sciencedirect.com/science/article/pii/S2451865423000601 |
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