Heart Failure
Conditions
Keywords
heart failure, motivational interviewing, self-care
Brief summary
Introduction: Heart failure (HF) is characterized by an increasing prevalence and burden, representing a public health problem and a major cause of morbidity and mortality. Self-care is a cornerstone approach for optimizing therapy for patients with HF; patients play a key role in the management of their condition, given that several negative health outcomes might be avoided with effective self-care. Motivational interviewing (MI) has been described by the literature as highly favorable for treating chronic diseases, with promising results supporting its efficacy in enhancing self-care. Moreover, caregivers' availability constitutes a fundamental supporting factor among the strategies to improve self-care behaviors in people with HF. Methods and analysis: This study protocol designed a prospective, parallel-arm, open-label, three-arm, controlled trial for purposing the aims to test the efficacy of a structured program including scheduled MI interventions in improving self-care behaviors among patients with HF at 3, 6, 9, and 12 months from the enrolment. Secondary aims comprehend the corroboration of the superiority of caregivers' participation to the structured program including scheduled MI interventions over the program administrated only to individual patients in enhancing self-care behaviors and other outcomes. Analyses will be performed within the framework of intention-to-treat (ITT). Comparisons between groups will be based on an alpha = 5% and two-tailed null hypotheses. In the case of missingness, analyzing the extent of the missingness and identifying underlying mechanisms and patterns will guide imputation methods. Ethics and dissemination: The study protocol and template consent forms have been reviewed and approved by the Ethical Committee of San Raffaele Hospital (approval #74/INT). Also, the study protocol has been registered at ClinicalTrials.gov (Identifier: …….). Patients and caregivers will have to sign the informed consent forms before the randomisation. Patients and caregivers may leave the study at any time. The withdrawal from the study will not imply any prejudice, as fully documented and explained in the informed consent. Considering the open-access publication, the full protocol will be available freely.
Interventions
BEHAVIORALMotivational Interviewing
Motivational Interviewing (MI) is a directive client-centred counselling approach for eliciting behavioral change by helping people to explore and resolve ambivalence. MI considers several critical factors to improving self-care in patients with HF and is based on brief interventions, which are feasible in several healthcare settings.
Sponsors
Azienda Socio Sanitaria Territoriale di Lodi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* age ≥ 18 years; * diagnosis of HF with New York Heart Association (NYHA) Class II-IV; * no acute coronary events within three months; * consent to participate in the study; * score ≤ 2 to at least two items of the Self-Care of Heart Failure Index 6.2 - SCHFI 6.2 at baseline; * score on Six Item Screener \> 4; * living at home; * understanding of spoken and written Italian.
Exclusion criteria
* severe cognitive impairment (score 0-4 on the Six-item Screener); * acute coronary events that occurred within three months; * living in nursing homes or residential settings; * caregivers unwilling to participate in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes will be assessed in the Level of self-care maintenance - Self-Care of Heart Failure Index 6.2 | 3, 6, 9, and 12 months from the enrollment | self-care behavior consisting in keeping the disease stable |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes will be assessed in the Level of cognitive impairment- Six Item Screener | 3, 6, 9, and 12 months from the enrollment | patients' cognitive impairment |
| Changes will be assessed in the Level of caregivers' involvement - Caregiver Contribution to Self-care of Heart Failure Index (CC-SCHFI) | 3, 6, 9, and 12 months from the enrollment | superiority of the caregivers' participation to the structured program including scheduled MI interventions over the program administrated only to individual patients in enhancing self-care behaviors |
| Changes will be assessed in the Level of physical function, symptoms, social function, self-efficacy, and quality of life (QoL) - Kansas City Cardiomyopathy Questionnaire (KCCQ) | 3, 6, 9, and 12 months from the enrollment | HF-specific QoL |
| Changes will be assessed in the Level of feeling of intimacy and positive relationship between patient and caregiver -Mutuality Scale (MS) | 3, 6, 9, and 12 months from the enrollment | feeling of intimacy and positive relationship between patient and caregiver |
| Changes will be assessed in the Level of physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health - SF-12 | 3, 6, 9, and 12 months from the enrollment | generic health-related QoL |
| Changes will be assessed in the Level of presence of significant sleep disturbance experienced in the month before the assessment - Pittsburgh Sleep Quality Index (PSQI) | 3, 6, 9, and 12 months from the enrollment | sleep quality |
| Changes will be assessed in the Level of patient's ability to feel the symptoms of HF - Heart Failure Somatic Perception Scale (HFSPS) | 3, 6, 9, and 12 months from the enrollment | patient's ability perceive the symptoms of HF |
| Changes will be assessed in the Level of cognitive impairment - Montreal Cognitive Assessment (MoCA) | 3, 6, 9, and 12 months from the enrollment | mild cognitive impairment |
| Changes will be assessed in the Number of comorbidities - Charlson Comorbidity Index (CCI) | 3, 6, 9, and 12 months from the enrollment | comorbidities |
| Changes will be assessed in the Level of caregiver contribution to self-care - Caregiver Contribution to Self-care of Heart Failure Index (CC-SCHFI) | 3, 6, 9, and 12 months from the enrollment | caregiver contribution to self-care in patients with HF |
| Changes will be assessed in the Level of caregiver Preparedness - Caregiver Preparedness Scale (CPS) | 3, 6, 9, and 12 months from the enrollment | Caregiver Preparedness to care |
| Changes will be assessed in the Level of social support - Multidimensional Scale of Perceived Social Support (MSPSS) | 3, 6, 9, and 12 months from the enrollment | level of social support perceived by HF patients in managing the disease |
| Changes will be assessed in the Level of depression and anxiety - Hospital Anxiety and Depression Scale (HADS) | 3, 6, 9, and 12 months from the enrollment | depression and anxiety |
Countries
Italy
Outcome results
None listed