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Abstract

Objective

Heart failure (HF) is a chronic condition requiring ongoing management to prevent complications. Telehealth interventions have shown effectiveness in managing HF, though further research is needed to optimize their implementation and outcomes for patients. The objective is to report a protocol for a systematic review and meta-analysis to evaluate and synthesize evidence associated with the clinical effectiveness of telehealth care on self-care behaviors in HF patients.

Methods

A systematic review and meta-analysis of randomized controlled trials will be initiated, and the search will be conducted in PubMed, Web of Science, and CINAHL, from 2016 to March 2025.

Results

Self-care behavior results will be the main outcome. The revised Cochrane risk-of-bias tool for randomized trials (Rob2) and the Joanna Briggs Institute (JBI) critique tool will be utilized to measure the risk of bias in different studies. The Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) will be used to evaluate the quality of evidence. If sufficient studies are accessible, subgroup analysis will evaluate differences according to the types of scales that measure self-care behaviors in HF. Additionally, sensitivity analysis will identify sources of potential heterogeneity.

Conclusion

The protocol will utilize a systematic review and meta-analysis to verify the effectiveness of telehealth care on self-care behaviors in HF patients. This work will improve the recognition and optimization of telehealth care, which is essential for enhancing self-care behaviors in HF patients.

Keywords

Effectiveness telehealth telehealth care intervention self-care heart failure

Introduction

Heart failure (HF) is an irreversible disease and significantly impacts patients, resulting in reduced functional capacity and decreased quality of life.¹ Approximately 64 million people worldwide suffer from this condition.² In the United States of America, the incidence of HF is anticipated to be between 2 and 5 cases per 1000 person-years. Meanwhile, in the United Kingdom, the prevalence has risen from 2.1% to 2.4%, impacting over 900,000 individuals.³ Patients frequently encounter episodes of HF decompensation, which often lead to prolonged hospital stays. Furthermore, the mortality rate among individuals diagnosed with HF in the Middle East has been reported to be between 25% and 50% within the first to fifth year, respectively.⁴

Managing HF poses considerable difficulties for healthcare providers and is even more taxing for patients, who are required to follow complex and often time-consuming self-care behaviors.^5,6 The management of HF includes using a range of medications with various dosing strategies, along with monitoring fluid intake, weighing themselves daily, increasing physical activity, and receiving influenza vaccinations.⁷ Engaging in self-care behaviors is crucial for individuals with HF, as these actions are crucial in managing the illness and enhancing overall health outcomes.⁵ Nevertheless, maintaining long-term commitment to the HF lifestyle can be quite difficult.⁸ Reaching this degree of commitment usually necessitates repeated interventions and follow-up from a multidisciplinary team, which often consists of doctors, nurses, nutritionists, mental health professionals, and exercise specialists.⁸

Telehealth technologies are increasingly being adopted and integrated into healthcare sectors as a viable and cost-effective means to deliver and access high-quality medical services and outcomes remotely.⁹ Employing telehealth services through video or phone calls, as well as other virtual tools, can reduce the necessity for in-person medical appointments.¹⁰ This method conserves time and lowers expenses for patients and healthcare providers, all while enhancing treatment efficiency.¹⁰ Additionally, due to its rapid and advantageous features, telehealth can enhance the operational system of hospitals and clinics. This advanced technology makes it simpler to monitor discharged patients and manage their treatment process¹⁰

Also, several studies in the literature have explored that remote monitoring has emerged as one of the most applied strategies for improving self-care behaviors.^11,12 Telehealth refers to using digital information and communication technologies to provide and facilitate healthcare services remotely.⁹ This can include a range of functions, such as virtual consultations among patients and healthcare clinicians, remote patient monitoring, mobile health applications, and the use of telecommunication tools for health education and follow-up.⁹

Growing numbers of studies have explored telehealth technologies and an increased desire to understand how they can enhance self-care behaviors among patients with HF.^5,8,13 Appropriate telehealth interventions, resulting in fewer hospitalizations and better management of HF symptoms, identifying specific telehealth care strategies that have been most successful in promoting self-care, including remote monitoring, educational applications, and telephone support. Understanding the most effective modalities will inform future telehealth care initiatives and improve patient outcomes.¹⁰ However, there is a lack of recent systematic reviews and meta-analyses evaluating the effectiveness of telehealth modalities and identifying which telehealth modalities are most suitable for the HF population, as well as determining the ideal frequency and duration of such interventions.¹² This protocol aims to report a systematic review and meta-analysis to evaluate and synthesize evidence associated with the clinical effectiveness of telehealth care on self-care behaviors in HF patients.

Methods

This proposed study is registered in PROSPERO (CRD420251026586) and adheres to the PRISMA-P checklist¹⁴ (see Supplemental file 1). The review is currently screening literature, with an expected completion date in June 2025.

Inclusion and exclusion criteria

The criteria for inclusion and exclusion will be determined based on the Population, Intervention, Comparison, and Outcome, as outlined in the PICO framework (insert Table 1 here).

Table 1.

Selection criteria of studies in PICO format.

PICO	Inclusion Criteria	Exclusion Criteria
Population (P)	Adult heart failure patients age 18+	Pediatric
Intervention (I)	Non-invasive telehealth delivered care (smartphone app, smart watches, web-based) conference/video call text messages	Face-to-face sessions Self-education intervention Lack of remote/wireless transmission of data
Comparison (C)	standard hospital care leaflet/ brochure on self-care standard heart failure guidelines	NA
Outcomes (O)	HF patients Self-care behaviors	Quality of life Mental health Family caregiver

Search strategy

A preliminary search will be conducted using Google Scholar, followed by a comprehensive search following a systematic search for English articles in PubMed, Web of Science, and CINAHL due to feasibility and resource accessibility. The search will include articles published from 2016 to March 2025. This 10-year research approach guaranteed that the systematic and meta-analysis review incorporated the most recent and pertinent studies in the field, while excluding outdated information.¹⁵ Search terms and strategies targeting studies that identify populations (patients with HF) and telehealth care interventions (telemedicine, telephone-delivered care, smartphone apps, text messages, non-invasive methods, e.g., smartwatches, web-based platforms, and video calls). The comparator or control group will consist of usual care or standard care, with outcomes focused on self-care behavior improvement; details are provided in (Supplemental file 2).

The reference lists of relevant studies will be examined to identify additional studies pertinent to the review.

Selection of studies

The selection of studies will be recorded with a PRISMA flowchart detailing which studies are included and excluded at each phase. Identified citations will first be imported into EndNote 20 for reference management, after which two independent reviewers will use Rayyan platform for duplicate removal, blinded title/abstract screening, and conflict resolution through its consensus features.¹⁶ Two reviewers will fully review studies that qualify based on set criteria, and a third-party reviewer will resolve any disagreements. The final selection process of the studies, including any subgroup analyses, will be visually summarized in the PRISMA flowchart (insert Figure 1 here).

Figure 1.

Plan of study screening and selection process

Data extraction

A standardized data extraction form will be created to collect information from the studies included. Two reviewers will separately extract from the initial 3–5 studies to ensure continued quality. After that, the two reviewers will incorporate frequent cross-checks and validate the extraction process. Following this, the remaining studies will be divided, with one reviewer extracting each, to maintain consistency and enhance the extraction form with the following information:

Study details: Author's name, year of publication, country, and limitations.

Participants’ characteristics: Sample size, age, HF severity (e.g., NYHA class).

Intervention details: Non-invasive telehealth care delivered type (e.g., Telephone delivered intervention; Telemedicine; Text Message, smartphone app, smart watches, web-based; conference/video call). The duration, frequency, and follow-up of the intervention delivery.

Comparator: Comparators include usual/standard care, such as in-person visits and the usual education provided by HF hospital guidelines and leaflets.

Outcomes: Self-care behaviors.

Assessment of risk of bias

Two authors will independently evaluate the risk of bias in the full-text studies included in the review, utilizing the revised Cochrane risk-of-bias tool for randomized trials, known as RoB 2,¹⁷ and the Joanna Briggs Institute (JBI) critique tool will be utilized for observational studies,¹⁸ such as checklists for cohort studies and case control studies. The JBI tool consists of 10 questions that evaluate the internal validity and risk of bias in case series designs. It specifically addresses issues such as confounding, selection bias, and information bias, along with emphasizing the importance of clear reporting.¹⁸ The quality of the RCT studies will be assessed through five domains: randomization process, deviation from intended intervention, missing outcome data, measurement of the outcome, selection of the reported results, and finally, overall risk of bias. In case of disagreement between the two authors, a consensus will be reached through a third author to make the definitive decision. The risk of bias will be presented as high, low, or some concerns.

Funnel plots and Egger's test will assess publication bias when there are 10 or more studies included.¹⁹ A p-value < 0.05 indicates potential publication bias, in which case the trim-and-fill technique will be used to modify the combined estimates and assess the influence of bias on the outcomes.²⁰

Missing data

For studies with incomplete or unclear data, the main author will be contacted for clarification. If no response is received or data cannot be provided, these missing data will be documented but excluded from the final analysis.

Assessment of intervention effects and data synthesis

All meta-analyses will be performed using MedCalc for Windows version 15.0 (MedCalc Software, Ostend, Belgium). For continuous outcomes with varying measurement scales, we will calculate standardized mean differences (SMDs) with 95% confidence intervals (CIs); for consistent measurement units, mean differences (MDs) with 95% CIs will be computed. Dichotomous outcomes will be analyzed using risk ratios (RRs) with 95% CIs.²¹ When reported statistics are unavailable, we will estimate means and standard deviations from available data (e.g., medians, ranges). Heterogeneity will be evaluated using I² statistics and chi-square tests (p ≤ 0.10 indicating significant heterogeneity). For homogeneous studies (I²≤50%, p > 0.10), fixed-effects models will be applied; otherwise, random-effects models will be used, supplemented by sensitivity/subgroup analyses to explore heterogeneity sources.²² Where quantitative synthesis is unfeasible, narrative synthesis will be performed. The package will also be used to create risk-of-bias assessment figures, which will summarize the results through funnel plots.

Grading the quality of evidence

The evidence quality will be assessed using the GRADE (Grading of Recommendations Assessment, Development, and Evaluation) framework,²³ which categorizes evidence quality into four tiers: high, moderate, low, and very low. This assessment will specifically examine the proportional efficacy of telehealth care interventions against usual care approaches in self-care behaviors in patients with HF. Any discrepancies in the evaluation process will be solved through discussion with a third independent reviewer.

Discussion

The domain of telehealth has seen considerable expansion, thanks to advancements in technology, and presents exciting prospects for healthcare.⁹ Since HF often manifests at a young age, individuals with this condition experience a complex set of challenges, leading to unfavorable health outcomes.¹ Engaging patients is vital for managing HF, with self-management being a crucial component of treatment.⁵

Investigating telehealth solutions for this group is essential for assessing their efficacy in addressing the specific requirements of these patients and enhancing their self-care behaviors.¹³ Remote monitoring and patient education delivered via telehealth can help HF individuals maintain consistent and adequate self-care. While several telehealth interventions have been examined in recent studies, there is a notable absence of systematic research and meta-analysis evaluating their effectiveness in relation to self-care. A prior review addressed the potential and applicability of eHealth for those with HF but didn't exclusively focus on self-care behaviors.²⁴

This systematic review and meta-analysis aim to synthesize the varied findings on telehealth care, which differ significantly in terms of intervention types, modalities, operational environments, frequency, duration of sessions, and follow-up periods. These factors are crucial in determining their effectiveness and accessibility for promoting self-care behaviors, impacting individuals’ involvement and adherence to treatment. By evaluating studies with inadequate power, it aspires to guide clinical practice for healthcare professionals, including nurses, physicians, and policymakers.²⁵

A thorough examination of credible data will provide valuable perspectives for professionals in health services, public health, and health policy. Such evidence will aid in crafting effective guidelines and support the implementation of suitable strategies for educational initiatives. It will also help researchers, nurses, and clinicians make informed choices about effective telehealth options tailored to individual HF outcomes. This study will utilise rigorous quality assessment tools in conjunction with a well-defined search strategy to guarantee both the reliability and relevance of the data. The expected findings aim to enhance the theoretical framework related to telehealth care and offer virtual awareness to enhance its implementation.

Conclusion

This protocol involves conducting a systematic review and a meta-analysis to synthesize findings from multiple randomized controlled trials. This approach will improve the reliability and accuracy of the results, offering valuable insights into the use of more effective telehealth care strategies for HF patients. This includes remote monitoring, educational applications, and telephone support. Understanding the most effective modalities will guide future telehealth care initiatives and improve patient outcomes.

Supplemental Material

sj-docx-1-dhj-10.1177_20552076251393292 - Supplemental material for Effectiveness of telehealth care on self-care behaviors in heart failure patients: Systematic review and meta-analysis protocol

Supplemental material, sj-docx-1-dhj-10.1177_20552076251393292 for Effectiveness of telehealth care on self-care behaviors in heart failure patients: Systematic review and meta-analysis protocol by Lujain Adel Sallam, Nora Ghalib AlOtaibi and Omar Ghazi Baker in DIGITAL HEALTH

Supplemental Material

sj-docx-2-dhj-10.1177_20552076251393292 - Supplemental material for Effectiveness of telehealth care on self-care behaviors in heart failure patients: Systematic review and meta-analysis protocol

Supplemental material, sj-docx-2-dhj-10.1177_20552076251393292 for Effectiveness of telehealth care on self-care behaviors in heart failure patients: Systematic review and meta-analysis protocol by Lujain Adel Sallam, Nora Ghalib AlOtaibi and Omar Ghazi Baker in DIGITAL HEALTH

Footnotes

Data availability

No data sharing is required for this study as it is an SRMA that relies on existing data from clinical trials rather than generating new data.

Acknowledgment

The authors would like to thank their universities for their continuous support.

ORCID iDs

Lujain Adel Sallam

Nora Ghalib AlOtaibi

Omar Ghazi Baker

Ethical approval

As this study is based on SRMA methods using existing clinical trial data, ethical approval was not required for this research.

Informed consent

As this study is based on SRMA methods using existing clinical trial data, participant consent was not required for this research.

Contributorship

LAS, NGO, and OGB made significant contributions to the study's conception and design, data acquisition, or data analysis and interpretation. All authors participated in drafting or critically revising the manuscript for essential intellectual content, and they provided final approval for publication. Each author has engaged sufficiently in the work to take public responsibility for their respective portions of the content. LAS, NGO, and OGB accepted accountabilities for all aspects of the work, ensuring that any concerns regarding the accuracy or integrity of any part are thoroughly investigated and resolved.

Funding

The authors received no financial support for the research, authorship, and/or publication of this article.

Declaration of conflicting interests

The authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Guarantor

LAS.

Supplemental material

Supplemental material for this article is available online.

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Supplementary Material

Please find the following supplemental material available below.

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