An interventional study of King's Theory of Goal Attainment and Standard Care (in control arm) in Heart Failure and Cardiac Rehabilitation, sponsored by Saglik Bilimleri Universitesi. Not yet recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by Saglik Bilimleri Universitesi · Not applicable, Interventional, and Supportive care
Heart failure is a chronic health condition associated with high morbidity and hospital readmission rates, negatively affecting patients' self-care behaviors, physical activity levels, and quality of life. Although cardiac rehabilitation programs offer significant benefits, the sustainability of self-care behaviors in the home environment remains a major challenge. There is a limited number of theory-based intervention studies that integrate components such as spousal support, structured education, and telemonitoring. This study aims to examine the impact of an intervention-structured according to Imogene King's Theory of Goal Attainment and incorporating spousal support, education, and telemonitoring-on the self-care behaviors and physical activity levels of patients with heart failure during their rehabilitation process. The study will be conducted as a randomized controlled trial with a pre-test/post-test control group design. The sample will consist of patients with NYHA Class II-III heart failure who are enrolled in a cardiac rehabilitation program. Ethical approval and institutional authorization will be obtained prior to the study. At the outset, all participants will undergo a pre-test, and their sociodemographic and clinical data will be assessed. The intervention group will receive face-to-face education during the first two weeks to initiate a goal-setting process, followed by weekly video-based educational modules over the next six weeks. Throughout this period, patients' symptoms, weight, medication adherence, and physical activity levels will be monitored via WhatsApp-based telemonitoring and weekly telephone calls. An interim assessment will be conducted at the sixth week; the intervention will span a total of 12 weeks, concluding with a post-test at the 12th week. The control group will receive only routine care. The video educational modules will be prepared in alignment with the current ESC and AHA/ACC/HFSA guidelines and developed using AI-powered digital tools, such as Google Flow and NotebookLM. Data will be collected using the European Heart Failure Self-Care Behaviour Scale, the International Physical Activity Questionnaire, the Perceived Partner Responsiveness Scale, and a Weekly Goal and Data Tracking Form. The study is expected to contribute to the development of a feasible and sustainable nursing care approach within the cardiac rehabilitation process.
Heart failure is a progressive, chronic clinical syndrome characterized by the heart's inability to pump blood at a level sufficient to meet the metabolic demands of the body's tissues. Affecting more than 64 million people globally, heart failure is associated with high morbidity and mortality, frequent hospital readmissions, a diminished quality of life, and increased healthcare system costs. Consequently, current guidelines from the European Society of Cardiology (ESC) and the American Heart Association/American College of Cardiology/Heart Failure Society of America (AHA/ACC/HFSA) emphasize that the management of heart failure should encompass not only pharmacological treatment but also patient education, self-care, lifestyle modifications, regular monitoring, and rehabilitation.
Cardiac rehabilitation is a multi-component care approach aimed at improving the physical capacity, symptom control, functional status, and quality of life of individuals with heart disease. Recent Cochrane reviews have demonstrated that exercise-based cardiac rehabilitation can enhance health-related quality of life and reduce the risk of hospital readmission in individuals with heart failure. A 2024 Cochrane update reported that exercise-based rehabilitation may not result in a significant difference in mortality, but it may offer benefits by reducing hospitalizations due to heart failure and all-cause hospital admissions.
Cardiac rehabilitation programs are multidisciplinary approaches effective in increasing exercise capacity, managing symptoms, and reducing hospital readmissions in patients with heart failure. Despite the efficacy of cardiac rehabilitation, access to these programs remains limited for many patients, and long-term adherence can be challenging. Factors such as difficulties in traveling to rehabilitation centers, loss of motivation, symptom burden, comorbidities, a lack of social support, and insufficient monitoring outside of the clinical setting negatively impact the sustainability of rehabilitation. The 2021 guidelines on cardiovascular disease prevention, published by the European Society of Cardiology (ESC), suggest that home-based cardiac rehabilitation, telehealth, and mobile health applications may be considered to enhance patient engagement and long-term adherence to healthy behaviors.
Recent studies indicate that telerehabilitation and remote monitoring have positive effects on the quality of life, exercise capacity, and adherence to rehabilitation among patients with heart failure. The TELEREH-HF randomized controlled trial demonstrated that patients undergoing hybrid telerehabilitation showed improved treatment adherence and a significant enhancement in their quality of life. Similarly, the CardioBBEAT study reported that remote telemonitoring practices improve quality of life and support patient monitoring in individuals with chronic heart failure. These findings highlight the necessity of supplementing hospital-based rehabilitation with education, monitoring, and support mechanisms provided in the home environment.
Patient education is a core component of heart failure management, as it fosters self-care behaviors. In recent years, alongside traditional face-to-face education, video-based, digital, and mobile-supported educational approaches have gained prominence. Video-based education allows patients to review information, facilitates learning through visual aids-which is particularly beneficial for those with lower literacy levels-and enables the inclusion of spouses in the educational process. It has been reported that discharge education supported by videos and booklets can enhance both quality of life and self-management behaviors in patients with heart failure. Systematic reviews evaluating educational approaches that incorporate the "teach-back" method underscore the importance of structured, repeatable, and patient-centered techniques for ensuring that patients understand information and translate it into behavioral change.
In the management of heart failure, social support is a significant determinant of a patient's adherence to treatment and their ability to sustain self-care behaviors. Support from a spouse or partner, in particular, can have a direct impact on a patient's ability to remember to take medications, engage in physical activity, adhere to salt and fluid restrictions, recognize symptoms early, and maintain motivation. However, the level of evidence derived from "dyadic" (pair-based/couple-focused) intervention studies-which address the patient-spouse dyad together in the context of heart failure-remains low. Furthermore, it has been noted that such studies should be supported by diverse sample groups, programs for sustainable behavioral change, and models that can be translated into clinical practice. Therefore, addressing peer support not merely as a form of natural support, but as a structured component of an intervention, helps fill a significant gap in the literature.
Tele-monitoring and remote tracking systems enable the monitoring of heart failure patients in their home environment, which can facilitate the early detection of symptom deterioration, promote adherence to treatment, and maintain communication between the patient and their healthcare team. Recent systematic reviews indicate that mobile health and telehealth-based interventions can have positive effects on self-care, hospital admissions, and patient-centered outcomes among individuals with heart failure. Moreover, it has been reported that interventions based on tele-monitoring practices have the potential to reduce heart failure-related readmissions, hospital expenses, and overall healthcare costs. A recent systematic review and meta-analysis found that telehealth and remote monitoring strategies are effective in reducing hospital readmissions and mortality in patients with heart failure. Nevertheless, it is suggested that in the management of heart failure, tele-monitoring practices-rather than being limited solely to symptom tracking-may prove more effective for sustaining self-care behaviors when integrated with components such as patient education, individual goal setting, and social support.
The theoretical foundation for this study is Imogene King's Theory of Goal Attainment. King's theory focuses on the process of interaction, communication, mutual perception, joint goal setting, and goal attainment between the nurse and the patient. In the context of chronic illnesses requiring long-term self-care-such as heart failure-this theory provides a robust framework that shifts the patient from being a passive recipient of care to an active participant in the decision-making process. In this thesis, Imogene King's Theory of Goal Attainment will be applied to support the adaptation of patients with heart failure to the cardiac rehabilitation process. This approach will be structured around the interaction between the patient, their spouse, and the nurse, utilizing goal setting, goal monitoring, and feedback-focused on self-care behaviors, physical activity, and symptom management-as the core mechanisms of the intervention.
Theory-based interventions ensure that nursing practices are developed in a structured, explicable, measurable, and replicable manner, rather than as ad hoc or incidental actions. While the existing literature addresses interventions for heart failure patients-such as education, telemonitoring, social support, and exercise-there is a limited number of holistic models that integrate these components with spousal support, guided by King's Theory of Goal Attainment and supplemented by video-based education and telemonitoring via WhatsApp or telephone. While current European (ESC) and American (AHA/ACC/HFSA) guidelines emphasize the importance of patient education, rehabilitation, self-care, and monitoring, there remains a need for practical models on how these components can be sustained in the home environment with the involvement of a spouse or partner.
This thesis was developed to address specific needs among patients with heart failure, including challenges in maintaining self-care behaviors during the cardiac rehabilitation process, insufficient levels of physical activity, a lack of continuous monitoring at home, and the limited availability of theory-based, comprehensive, nurse-led interventions.
The study will implement a multidimensional, theory-based nursing intervention for patients with heart failure undergoing cardiac rehabilitation. This intervention incorporates partner support, education, and tele-monitoring to improve self-care behaviors and physical activity levels. Video-based educational modules will enhance patients' knowledge and awareness regarding disease management, symptom recognition, medication adherence, fluid and salt restriction, and physical activity; meanwhile, partner support will facilitate the maintenance of self-management behaviors in daily life and the home environment. Furthermore, tele-monitoring will enable the regular assessment of symptoms, weight tracking, the early detection of clinical deterioration, and timely clinical guidance. In this regard, the study aims to establish a sustainable, nurse-led model of care that bridges hospital-based rehabilitation with home-based self-care.
5,812 studies on the registry are indexed under Heart Failure; 1,227 are open to participants now.
This study's planned enrollment of 40 is below the median of 72 across 3,794 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →Saglik Bilimleri Universitesi is the lead sponsor of 452 studies on the registry; 141 are open to participants now.
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Exclusion Criteria:
Live alone, Use orthoses and/or prostheses that limit physical movement, Have undergone orthopedic surgery within the last year, Have had their treatment concluded by a physician, and/or Do not regularly attend a cardiac rehabilitation program.
CONTROL GROUP: FOLLOW-UP AND WORKFLOW 0. Preparation Phase / Pre-Implementation Phase * Patients meeting the inclusion and exclusion criteria for the study will be identified. * Written informed consent will be obtained from patients who agree to participate in the study. * Patients will be assigned to the control group via a randomization method. Week 1 / Initial Consultation (Monday) * An initial face-to-face meeting will be held with the patient in the control group to explain the purpose of the study and the follow-up process. * Pre-test scales will be administered. * The patient will be monitored in accordance with the hospital's routine cardiac rehabilitation program and standard care process. Weeks 2-11 / Routine Care Process •Patients in the control group will continue with the cardiac rehabilitation unit's routine program. Week 12 / Final Assessment (Friday) •A final face-to-face assessment will be conducted with the patient in the control group.
Other: Standard Care (in control arm)
A group that received, in addition to routine cardiac rehabilitation, partner support based on King's Theory of Goal Attainment, face-to-face and video-based educational modules, and tele-monitoring via WhatsApp/telephone.
Behavioral: King's Theory of Goal Attainment
The original contribution of this thesis lies in its provision of a theory-based, multi-component, and sustainable nursing care model designed to enhance self-care behaviors in patients with heart failure during the cardiac rehabilitation process. Existing research typically focuses on clinical outcomessuch as hospital readmission, mortality, or symptom control in patients diagnosed with heart failure, often failing to integrate self-care behaviors, goal setting, and the processes of behavioral change within a cohesive theoretical framework. In this study, Imogene King's Theory of Goal Attainment serves as the foundation for structuring interactions between the patient with heart failure, their spouse, and the nurse, with goal setting, regular monitoring, and feedback processes placed at the core of the intervention. This approach moves beyond simple information transfer, establishing a holistic care model that fosters behavioral change and self-management in the context of HF.
Also known as: a) Development of a spousal support program aimed at assisting patients with heart failure, b) Provision of face-to-face education for patients and their spouses regarding the improvement of self-care behaviors, c) Development of video-based educational modules and the delivery of education to patients with heart failure, d) Monitoring of patients with heart failure via telemonitoring
The group that continues only with the institution's standard clinical follow-up, routine care, and cardiac rehabilitation program (in accordance with ethical principles, the educational and video modules will be shared with this group as well, once the study has concluded).
Change in Self-Care Behaviors
Self-care behaviors will be assessed using a 12-item, 5-point Likert-type scale evaluating treatment adherence, adaptation to daily activities, compliance with recommendations, and help-seeking behaviors. The total score ranges from 12 to 60, with lower scores indicating better self-care behaviors. Scores of 12-36 indicate adequate self-care, whereas scores of 37-60 indicate inadequate self-care. The total scale score will be reported.
Time frame: Beginning (Week 1 - Pre-test), Week 6 (Mid-term Assessment), and Week 12 (Post-test).
Change in Total Physical Activity (MET-minutes/week)
Total weekly physical activity will be assessed using self-reported walking, moderate-intensity activity, and vigorous-intensity activity performed during the preceding seven days. Total energy expenditure will be calculated as the sum of walking (3.3 METs), moderate-intensity activity (4.0 METs), and vigorous-intensity activity (8.0 METs), each multiplied by the corresponding duration and weekly frequency. Results will be reported as MET-minutes/week. Higher values indicate greater physical activity.
Time frame: Beginning (Week 1 - Pre-test), Week 6 (Mid-term Assessment), and Week 12 (Post-test).
Change in Physical Activity Classification
Participants will be classified into three physical activity categories: Inactive, Minimally Active, and Highly Active, based on self-reported physical activity during the preceding seven days and predefined physical activity scoring criteria. The number of participants in each category will be reported at each assessment time point.
Time frame: Week 1 (Baseline), Week 6, and Week 12.
Change in Daily Sitting Time (minutes/day)
Self-reported daily sitting time will be assessed as the duration of time spent sitting during the preceding seven days. Results will be expressed in minutes per day. Sitting time will be reported separately from total physical activity energy expenditure.
Time frame: Week 1 (Baseline), Week 6, and Week 12.
Change in Perceived Mattering to Partner Total Score
Perceived mattering to one's spouse or partner will be assessed using a 17-item, 5-point Likert-type scale measuring the extent to which participants perceive themselves as cared for, valued, and important to their partners. The total score ranges from 17 to 85, assuming each item is scored from 1 to 5. Higher scores indicate greater perceived mattering to one's partner. The total scale score will be reported.
Time frame: Beginning (Week 1 - Pre-test), Week 6 (Mid-term Assessment), and Week 12 (Post-test).
Individual Goal Attainment and Self-Management Total Score
Individual goal attainment and self-management adherence will be assessed using a 20-item composite scoring instrument based on King's Theory of Goal Attainment. The instrument evaluates attainment of predefined individualized goals related to medication adherence, weight and symptom monitoring, physical activity, fluid and salt restriction, educational video engagement, partner involvement, and SMART goal quality. The total score ranges from 0 to 60, with higher scores indicating greater goal attainment and adherence. Weekly WhatsApp reports and telephone follow-up records will provide supporting data for the composite score.
Time frame: Week 6 and Week 12, using weekly monitoring data collected during Weeks 1-12 (intervention group only).
Change in Body Mass Index (kg/m²)
Body Mass Index (BMI) will be calculated by dividing body weight in kilograms by the square of height in meters (kg/m²). BMI will be assessed using routine clinical measurement records. Results will be reported in kg/m².
Time frame: Baseline (Week 1) and Week 12
Change in Left Ventricular Ejection Fraction (%)
Left ventricular ejection fraction (LVEF) will be obtained from routine echocardiographic assessment records. LVEF represents the percentage of blood ejected from the left ventricle during systole. Results will be expressed as a percentage (%).
Time frame: Week 1 (Baseline) and Week 12.
Change in Total Cholesterol (mg/dL)
Serum total cholesterol concentrations will be obtained from routine lipid profile laboratory records. Results will be expressed in milligrams per deciliter (mg/dL).
Time frame: Week 1 (Baseline) and Week 12.
Plan to share: No
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