Heart failure (HF) is characterized as a prevalent chronic disorder with a multitude of complexities and considerable morbidity and mortality (1). As with its high prevalence worldwide (2), HF prevalence in Iran is estimated to be high, at approximately 8% (3), making it a serious concern in the Iranian healthcare system (4). Patients afflicted with HF commonly experience debilitating clinical manifestations and recurrent episodes of disease exacerbation, leading to a decline functional capability and disruption of their daily activities (5). Moreover, the effective management of this disease is an intricate undertaking requiring significant lifestyle modifications, strict adherence to a multiple medication regimen, and regular medical visits (6) The uncertain and precarious trajectory of heart failure, along with the complexity of its management, not only affect the physical aspects of the disease but also have psychological and social implications, including depression, mental distress, and reduced quality of life (QoL) in both patients with HF (7,8), and their caregivers (9). Additionally, the impact of HF places significant strain on both patients and the healthcare system, leading to frequent hospitalizations, escalating healthcare expenses, and diminished QoL(10). All of these factors highlight the importance of a holistic approach for these patients.
As an integrated and comprehensive approach, palliative care, focuses on early identification, correct assessment, and treatment of pain and other physical, psychosocial, or spiritual problems(11). This approach helps improve the QoL of patients facing serious diseases or life-threatening circumstances (12,13). Given the unpredictable trajectory of HF and the challenges in prognostication, it is recommended to integrate palliative care at an early stage when patients are still highly functional (14,15). While early palliative care has been explored for its potential benefits in maintaining or enhancing patients'QoL (16), the evidence presents a mixed picture, particularly in heart failure where findings remain equivocal. Previous studies have demonstrated the beneficial outcomes of early palliative care models and interventions in patients with serious conditions such as cancer (17,18), HF (19) or other severe diseases (16,20), with only one study focusing on early palliative care in Iranian heart failure patients (21). On the other hand, Iran currently lacks a well-defined and specific framework for providing palliative and supportive care, especially tailored for heart failure patients (22), highlighting the urgent need for action in this regard. One potential approach to address this gap is through the cultural adaptation of existing early palliative care interventions or models for the Iranian populace. Among these, the ENABLE model emerges as one of the most promising and evidence-based early palliative care interventions.
ENABLE (Educate, Nurture, Advise, Before Life Ends) is a nurse coach-led, telehealth, potentially scalable model to integrate early palliative care for the patients and their caregivers (23,24). The ENABLE model provides comprehensive guidance and skills training to patients and family caregivers care, on common issues arising across the HF disease trajectory including effective symptom management, self-care , crisis prevention, problem-solving,decision-making, coping mechanisms, advance care planning, and approaches to facilitate communication between patients, families, and healthcare providers (25,26). Although, a growing body of literature has examined the significant impact of the ENABLE program on cancer patients and their caregivers (23,24), this model has had only limited testing on U.S. HF patients demonstrating feasibility (27) and some positive outcomes (19). Project ENABLE was originally designed for cancer patients living in rural states of the United States (26,28), and has been adapted for implementation in other geocultural contexts such as African-American communities (29), Turkey (30), and Singapore (31,32).
Given the Medical Research Council (MRC) guidance, the feasibility, acceptability and effectiveness of complex interventions, such as ENABLE, depends on factors such as the community and cultural context in which the intervention is implemented (33). Therefore, cultural adaptation is the first critical step in determining the appropriate and effective principles for the implementation of care programs in different communities. Consequently, the ENABLE model has been generating considerable interest in terms of cultural adaptation as a comprehensive early palliative care model in diverse contexts (25). Although some aspects of ENABLE, such as symptom management are widely prevalent and cross-culturally relevant in HF patients, other topics such as advance care planning, spiritual needs, or the way the program would be delivered may differ in countries like Iran which has very different cultural backgrounds and religious beliefs (29,31,34). For example, thinking and planning about end-of-life, can be challenging in Iranian culture, where death is commonly perceived as a dreadful, grim and tragic event that could occur at any moment (35). Some believe that talking about death and severe conditions will cause these events to occur (36). In addition, a crucial component of dealing with HF is paying attention to the spirituality and religious beliefs of patients, especially in the highly religious Iran culture (37). For example, faith in God's will and divine destiny play a significant role in pursuing religious assistance and hope in Iranian society (34,38). Therefore, the perspectives, beliefs, cultural thoughts, and religious values of Iranian patients can influence their preferences about the health care they receive (39). This point must be taken into account when developing an intervention in this unique context (40).
According to the MRC framework for developing and evaluating complex interventions, there are four perspectives that can be used to guide a complex intervention, including efficacy, effectiveness, theory based, and systems. The theory based perspective can be beneficial in adaptive intervention research, because it focuses on understanding how an intervention works and the interplay between mechanisms and context, thus emphasizing the importance of developing and testing theories that underpin the intervention and refining them as necessary(41).
ENABLE, informed by Wagner's Chronic Care (CIC) model (27), which has also been used successfully to inform care for Iranian patients with chronic diseases (42). However, it is essential to evaluate whether the theoretical foundations of the CIC model remain applicable in a population of heart failure patients receiving early palliative care. As suggested by the MRC guidance, qualitative designs may be necessary to address questions that go beyond effectiveness, particularly in the context of adaptive intervention research, where interventions are tailored to specific populations and settings(41). It is generally believed that qualitative methods are valuable tools to explore the way an intervention can be improved because they can provide information on how and why a new method fails or succeeds, as well as how patients and providers perceive a care service (43). Since qualitative approaches provide in-depth information, perspectives and insights, this method could shed new light on ENABLE model in terms of cultural adaptation in Iranian context especially related to patients' spiritual, social, and cultural perspectives (44). These insights are of vital importance as they can reveal the intricacies and nuances of human behavior when faced with disease and its treatment (45).
Due to the necessity of examining a suitable early palliative care model in HF patients and their caregivers in the cultural context of Iran and also the importance of investigating the cultural adaptation of care-providing models developed in other countries, this paper describes the study protocol to be used to meet study aims of exploring cultural relevance and modifications for an adapted ENABLE model in Iranian patients living with HF in a two-phase study as below:
Objectives
The objectives of this study are as follows:
Main objective: Cultural adaptation of the ENABLE (Educate, Nurture, Advise, Before Life Ends) as an early palliative care model among heart failure patients and caregivers in Iran.
The Specific Objective of the First Phase: Translation and validation of ENABLE model contents.
The Specific Objective of the Second Phase: Semi-structured interviews with heart failure patients, their caregivers and healthcare providers to obtain their views on: 1) the clarity and appropriateness of the translated content and the text of the ENABLE intervention, 2) the relevance of translated ENABLE topics to the primary needs and challenges faced by individuals of patients and their caregivers, 3) and their preferred delivery method (such as phone or face-to-face).