Heart FailureNCT07917052
King's Theory-Based Multicomponent Interventions in Heart Failure Patient Rehabilitation
A study testing King's Theory of Goal Attainment in people with Heart Failure and Cardiac Rehabilitation, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Cardiac Rehabilitation
- What is being tested?
- King's Theory of Goal Attainment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Dec 2026to Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients enrolling in a cardiac rehabilitation program for the first time,
- Patients with heart failure classified as NYHA stage II or III,
- Patients aged 18 years or older,
- Patients capable of using a smartphone,
- Patients who understand, read, and speak Turkish,
- Patients whose general condition is suitable for an interview and who have no history of any psychiatric illness,
- Patients living with their partner/spouse,
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Kartal Koşuyolu Training and Research Hospital
Istanbul, Kartal, 34668
Büşra Z BÜYÜKKILIÇ, +90 543 627 82 84, busrabuyukklc@gmail.com
About this study
Official title: "The Effect of Spousal Support, Education, and Telemonitoring Based on King's Theory of Goal Attainment on Self-Care Behaviors and Physical Activity Levels in the Rehabilitation of Patients With Heart Failure"
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.
Read the detailed description
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.
- Conditions
- Heart Failure, Cardiac Rehabilitation
- Being tested
- King's Theory of Goal Attainment, Standard Care (in control arm)
- Keywords
- Heart Failure, Cardiac Rehabilitation, Self Care, Telemedicine, Spouses, Patient Education, Nursing Care Delivery Model
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
King's Theory of Goal AttainmentBehavioural
Also called 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 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.
Standard Care (in control arm)Other
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).
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | 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. Receives: Other: Standard Care (in control arm) |
| Intervention arm | Experimental | 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. Receives: Behavioral: King's Theory of Goal Attainment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Week 1 (Baseline), Week 6, and Week 12.
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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 (%).
Measured: 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).
Measured: Week 1 (Baseline) and Week 12.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2026
- Study startDec 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients included in the intervention group and their spouses will receive training on spousal support and disease management. Initially, in-person training sessions covering various topics are planned for the first two weeks, held on Mondays. Following these initial two weeks of in-person training, patients and their spouses will be encouraged to engage with AI-supported video training modules. The topics covered in both the in-person sessions and the video modules include: 1) Self-care behaviors in heart failure; 2) Symptom monitoring and daily weight tracking; 3) Adherence to medication; 4) Physical activity and exercise; 5) Nutrition, as well as salt and fluid management; and 6) Spousal support, goal setting, and quality of life. These educational topics will be provided to the patients via the WhatsApp application in the form of video modules, which they will be encouraged to watch whenever needed. Patients and their spouses in the intervention group will participate in weekly tel
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Büşra Zehra BÜYÜKKILIÇ, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07917052
- Sponsor's protocol ID
- BZBuyukkilic
- Status last verified
- Nov 2026
- First submitted
- 27 Oct 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mak, L., & Marshall, S. K. (2004). Perceived mattering in young adults' romantic relationships. Journal of Social and Personal Relationships, 21(4), 469-486. Doi: 10.1177/026540750404484
Craig CL, Marshall AL, Sjostrom M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, Oja P. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003 Aug;35(8):1381-95. doi: 10.1249/01.MSS.0000078924.61453.FB.
PubMed 12900694Jaarsma T, Stromberg A, Martensson J, Dracup K. Development and testing of the European Heart Failure Self-Care Behaviour Scale. Eur J Heart Fail. 2003 Jun;5(3):363-70. doi: 10.1016/s1388-9842(02)00253-2.
PubMed 12798836Mullens W, Damman K, Dhont S, Banerjee D, Bayes-Genis A, Cannata A, Chioncel O, Cikes M, Ezekowitz J, Flammer AJ, Martens P, Mebazaa A, Mentz RJ, Miro O, Moura B, Nunez J, Ter Maaten JM, Testani J, van Kimmenade R, Verbrugge FH, Metra M, Rosano GMC, Filippatos G. Dietary sodium and fluid intake in heart failure. A clinical consensus statement of the Heart Failure Association of the ESC. Eur J Heart Fail. 2024 Apr;26(4):730-741. doi: 10.1002/ejhf.3244. Epub 2024 Apr 12.
PubMed 38606657Fronczek AE. Ushering in a New Era for King's Conceptual System and Theory of Goal Attainment. Nurs Sci Q. 2022 Jan;35(1):89-91. doi: 10.1177/08943184211051373.
PubMed 34939499Alqahtani AS. Telehealth-Based Cardiac Rehabilitation for Heart Failure: A Systematic Review of Effectiveness, Access, and Patient-Centred Outcome. Medicina (Kaunas). 2025 Dec 23;62(1):25. doi: 10.3390/medicina62010025.
PubMed 41597311Yang Q, Ma H, Huang J, Liu X, Wang Y, Li Z, Cheng Y, Wu Q, Hu K, Liu J, Qiu W, Chao Y, Lyu Q. Collaborative couple-based management using King's theory improves health behaviours after percutaneous coronary intervention for coronary artery disease: randomized controlled trial. Eur J Cardiovasc Nurs. 2025 Oct 22;24(7):1052-1064. doi: 10.1093/eurjcn/zvaf076.
PubMed 40320893Buck HG, Stromberg A, Chung ML, Donovan KA, Harkness K, Howard AM, Kato N, Polo R, Evangelista LS. A systematic review of heart failure dyadic self-care interventions focusing on intervention components, contexts, and outcomes. Int J Nurs Stud. 2018 Jan;77:232-242. doi: 10.1016/j.ijnurstu.2017.10.007. Epub 2017 Oct 19.
PubMed 29128777Zare-Kaseb A, Emami Zeydi A, Bakhtiari-Dovvombaygi H, Nazari AM. Effects of education based on teach-back methods on self-care and quality of life of the patients with heart failure: a systematic review. BMC Cardiovasc Disord. 2024 Oct 26;24(1):591. doi: 10.1186/s12872-024-04264-5.
PubMed 39462344Arofiati F, Lestari FD, Setiawan H. The Effect of Discharge Planning Videos and Booklets on Quality of Life Among Patients With Heart Failure: Quasi-Experimental Study. JMIR Cardio. 2025 Sep 5;9:e75417. doi: 10.2196/75417.
PubMed 40916514Voller H, Bindl D, Nagels K, Hofmann R, Vettorazzi E, Wegscheider K, Fleck E, Stork S, Nagel E. The First Year of Noninvasive Remote Telemonitoring in Chronic Heart Failure Is not Cost Saving but Improves Quality of Life: The Randomized Controlled CardioBBEAT Trial. Telemed J E Health. 2022 Mar 21;28(11):1613-22. doi: 10.1089/tmj.2022.0021. Online ahead of print.
PubMed 35325562Piotrowicz, E., Pencina, M., Opolski, G., Zaręba, W., Banach, M., Kowalik, I., et al., Piotrowicz, R. (2022). Heart failure patients' adherence to hybrid comprehensive telerehabilitation and its impact on prognosis based on data from TELEREH-HF randomized clinical trial. Applied Sciences, 12(5), 2595. doi:10.3390/app12052595.
Visseren FLJ, Mach F, Smulders YM, Carballo D, Koskinas KC, Back M, Benetos A, Biffi A, Boavida JM, Capodanno D, Cosyns B, Crawford C, Davos CH, Desormais I, Di Angelantonio E, Franco OH, Halvorsen S, Hobbs FDR, Hollander M, Jankowska EA, Michal M, Sacco S, Sattar N, Tokgozoglu L, Tonstad S, Tsioufis KP, van Dis I, van Gelder IC, Wanner C, Williams B; ESC National Cardiac Societies; ESC Scientific Document Group. 2021 ESC Guidelines on cardiovascular disease prevention in clinical practice. Eur Heart J. 2021 Sep 7;42(34):3227-3337. doi: 10.1093/eurheartj/ehab484. No abstract available.
PubMed 34458905Molloy C, Long L, Mordi IR, Bridges C, Sagar VA, Davies EJ, Coats AJ, Dalal H, Rees K, Singh SJ, Taylor RS. Exercise-based cardiac rehabilitation for adults with heart failure. Cochrane Database Syst Rev. 2024 Mar 7;3(3):CD003331. doi: 10.1002/14651858.CD003331.pub6.
PubMed 38451843Long L, Mordi IR, Bridges C, Sagar VA, Davies EJ, Coats AJ, Dalal H, Rees K, Singh SJ, Taylor RS. Exercise-based cardiac rehabilitation for adults with heart failure. Cochrane Database Syst Rev. 2019 Jan 29;1(1):CD003331. doi: 10.1002/14651858.CD003331.pub5.
PubMed 30695817
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "The Effect of Spousal Support, Education, and Telemonitoring Based on King's Theory of Goal Attainment on Self-Care Behaviors and Physical Activity Levels in the Rehabilitation of Patients With Heart Failure"
- ClinicalTrials.gov ID
- NCT07917052
- Acronym / sponsor ID
- BZBuyukkilic
- Conditions
- Heart Failure, Cardiac Rehabilitation
- Keywords
- Heart Failure, Cardiac Rehabilitation, Self Care, Telemedicine, Spouses, Patient Education, Nursing Care Delivery Model
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- Dec 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 4 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients included in the intervention group and their spouses will receive training on spousal support and disease management. Initially, in-person training sessions covering various topics are planned for the first two weeks, held on Mondays. Following these initial two weeks of in-person training, patients and their spouses will be encouraged to engage with AI-supported video training modules. The topics covered in both the in-person sessions and the video modules include: 1) Self-care behaviors in heart failure; 2) Symptom monitoring and daily weight tracking; 3) Adherence to medication; 4) Physical activity and exercise; 5) Nutrition, as well as salt and fluid management; and 6) Spousal support, goal setting, and quality of life. These educational topics will be provided to the patients via the WhatsApp application in the form of video modules, which they will be encouraged to watch whenever needed. Patients and their spouses in the intervention group will participate in weekly tel
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Other: Standard Care (in control arm)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. |
| Intervention arm | Experimental | Behavioral: King's Theory of Goal AttainmentA 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients enrolling in a cardiac rehabilitation program for the first time,
- Patients with heart failure classified as NYHA stage II or III,
- Patients aged 18 years or older,
- Patients capable of using a smartphone,
- Patients who understand, read, and speak Turkish,
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| King's Theory of Goal AttainmentAlso: 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 telemonitoringThe 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. | Behavioural | Intervention arm |
| Standard Care (in control arm)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). | Other | Control Group |
Primary outcome
Change in Self-Care Behaviors
Time frame: Beginning (Week 1 - Pre-test), Week 6 (Mid-term Assessment), and Week 12 (Post-test).
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.
Change in Total Physical Activity (MET-minutes/week)
Time frame: Beginning (Week 1 - Pre-test), Week 6 (Mid-term Assessment), and Week 12 (Post-test).
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.
Change in Physical Activity Classification
Time frame: Week 1 (Baseline), Week 6, and Week 12.
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.
Change in Daily Sitting Time (minutes/day)
Time frame: Week 1 (Baseline), Week 6, and Week 12.
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.
5 secondary outcomes
Change in Perceived Mattering to Partner Total Score
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
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)
Time frame: Baseline (Week 1) and Week 12
Change in Left Ventricular Ejection Fraction (%)
Time frame: Week 1 (Baseline) and Week 12.
Change in Total Cholesterol (mg/dL)
Time frame: Week 1 (Baseline) and Week 12.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- BackgroundMak, L., & Marshall, S. K. (2004). Perceived mattering in young adults' romantic relationships. Journal of Social and Personal Relationships, 21(4), 469-486. Doi: 10.1177/026540750404484
- Background: PubMed 12900694Craig CL, Marshall AL, Sjostrom M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, Oja P. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003 Aug;35(8):1381-95. doi: 10.1249/01.MSS.0000078924.61453.FB.
- Background: PubMed 12798836Jaarsma T, Stromberg A, Martensson J, Dracup K. Development and testing of the European Heart Failure Self-Care Behaviour Scale. Eur J Heart Fail. 2003 Jun;5(3):363-70. doi: 10.1016/s1388-9842(02)00253-2.
- Background: PubMed 38606657Mullens W, Damman K, Dhont S, Banerjee D, Bayes-Genis A, Cannata A, Chioncel O, Cikes M, Ezekowitz J, Flammer AJ, Martens P, Mebazaa A, Mentz RJ, Miro O, Moura B, Nunez J, Ter Maaten JM, Testani J, van Kimmenade R, Verbrugge FH, Metra M, Rosano GMC, Filippatos G. Dietary sodium and fluid intake in heart failure. A clinical consensus statement of the Heart Failure Association of the ESC. Eur J Heart Fail. 2024 Apr;26(4):730-741. doi: 10.1002/ejhf.3244. Epub 2024 Apr 12.
- Background: PubMed 34939499Fronczek AE. Ushering in a New Era for King's Conceptual System and Theory of Goal Attainment. Nurs Sci Q. 2022 Jan;35(1):89-91. doi: 10.1177/08943184211051373.
- Background: PubMed 41597311Alqahtani AS. Telehealth-Based Cardiac Rehabilitation for Heart Failure: A Systematic Review of Effectiveness, Access, and Patient-Centred Outcome. Medicina (Kaunas). 2025 Dec 23;62(1):25. doi: 10.3390/medicina62010025.
- Background: PubMed 40320893Yang Q, Ma H, Huang J, Liu X, Wang Y, Li Z, Cheng Y, Wu Q, Hu K, Liu J, Qiu W, Chao Y, Lyu Q. Collaborative couple-based management using King's theory improves health behaviours after percutaneous coronary intervention for coronary artery disease: randomized controlled trial. Eur J Cardiovasc Nurs. 2025 Oct 22;24(7):1052-1064. doi: 10.1093/eurjcn/zvaf076.
- Background: PubMed 29128777Buck HG, Stromberg A, Chung ML, Donovan KA, Harkness K, Howard AM, Kato N, Polo R, Evangelista LS. A systematic review of heart failure dyadic self-care interventions focusing on intervention components, contexts, and outcomes. Int J Nurs Stud. 2018 Jan;77:232-242. doi: 10.1016/j.ijnurstu.2017.10.007. Epub 2017 Oct 19.
- Background: PubMed 39462344Zare-Kaseb A, Emami Zeydi A, Bakhtiari-Dovvombaygi H, Nazari AM. Effects of education based on teach-back methods on self-care and quality of life of the patients with heart failure: a systematic review. BMC Cardiovasc Disord. 2024 Oct 26;24(1):591. doi: 10.1186/s12872-024-04264-5.
- Background: PubMed 40916514Arofiati F, Lestari FD, Setiawan H. The Effect of Discharge Planning Videos and Booklets on Quality of Life Among Patients With Heart Failure: Quasi-Experimental Study. JMIR Cardio. 2025 Sep 5;9:e75417. doi: 10.2196/75417.
- Background: PubMed 35325562Voller H, Bindl D, Nagels K, Hofmann R, Vettorazzi E, Wegscheider K, Fleck E, Stork S, Nagel E. The First Year of Noninvasive Remote Telemonitoring in Chronic Heart Failure Is not Cost Saving but Improves Quality of Life: The Randomized Controlled CardioBBEAT Trial. Telemed J E Health. 2022 Mar 21;28(11):1613-22. doi: 10.1089/tmj.2022.0021. Online ahead of print.
- BackgroundPiotrowicz, E., Pencina, M., Opolski, G., Zaręba, W., Banach, M., Kowalik, I., et al., Piotrowicz, R. (2022). Heart failure patients' adherence to hybrid comprehensive telerehabilitation and its impact on prognosis based on data from TELEREH-HF randomized clinical trial. Applied Sciences, 12(5), 2595. doi:10.3390/app12052595.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing King's Theory of Goal Attainment in people with Heart Failure and Cardiac Rehabilitation, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Busra Z BUYUKKILIC (+90 543 627 82 84, busrazehra.buyukkilic@sbu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Self-Care Behaviors (time frame: Beginning (Week 1 - Pre-test), Week 6 (Mid-term Assessment), and Week 12 (Post-test).). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07917052, which also lists 19 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.