Clinical trial NCT05595655: Randomized Controlled Trial to Test the Efficacy of Motivational Interviewing on Self-care
Official title: Tailored Intervention for Self-Care Promotion in Patients With Heart Failure: Protocol for a Randomized Controlled Trial to Test the Efficacy of Motivational Interviewing on Self-care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Keywords: heart failure
motivational interviewing
self-care
Lead sponsor: Azienda Socio Sanitaria Territoriale di Lodi
Sponsor class: OTHER
First posted: 2022-10-27
Enrollment: 180
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_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.


Eligibility criteria: 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.

Primary outcomes:
measure: Changes will be assessed in the Level of self-care maintenance - Self-Care of Heart Failure Index 6.2
timeFrame: 3, 6, 9, and 12 months from the enrollment
Secondary outcomes:
measure: Changes will be assessed in the Level of caregivers' involvement - Caregiver Contribution to Self-care of Heart Failure Index (CC-SCHFI)
timeFrame: 3, 6, 9, and 12 months from the enrollment
measure: Changes will be assessed in the Level of patient's ability to feel the symptoms of HF - Heart Failure Somatic Perception Scale (HFSPS)
timeFrame: 3, 6, 9, and 12 months from the enrollment
measure: Changes will be assessed in the Level of cognitive impairment- Six Item Screener
timeFrame: 3, 6, 9, and 12 months from the enrollment
measure: 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)
timeFrame: 3, 6, 9, and 12 months from the enrollment
measure: Changes will be assessed in the Level of feeling of intimacy and positive relationship between patient and caregiver -Mutuality Scale (MS)
timeFrame: 3, 6, 9, and 12 months from the enrollment
measure: 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
timeFrame: 3, 6, 9, and 12 months from the enrollment
measure: 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)
timeFrame: 3, 6, 9, and 12 months from the enrollment
measure: Changes will be assessed in the Level of depression and anxiety - Hospital Anxiety and Depression Scale (HADS)
timeFrame: 3, 6, 9, and 12 months from the enrollment
measure: Changes will be assessed in the Level of cognitive impairment - Montreal Cognitive Assessment (MoCA)
timeFrame: 3, 6, 9, and 12 months from the enrollment
measure: Changes will be assessed in the Number of comorbidities - Charlson Comorbidity Index (CCI)
timeFrame: 3, 6, 9, and 12 months from the enrollment
measure: Changes will be assessed in the Level of caregiver contribution to self-care - Caregiver Contribution to Self-care of Heart Failure Index (CC-SCHFI)
timeFrame: 3, 6, 9, and 12 months from the enrollment
measure: Changes will be assessed in the Level of caregiver Preparedness - Caregiver Preparedness Scale (CPS)
timeFrame: 3, 6, 9, and 12 months from the enrollment
measure: Changes will be assessed in the Level of social support - Multidimensional Scale of Perceived Social Support (MSPSS)
timeFrame: 3, 6, 9, and 12 months from the enrollment
Other outcomes:
Locations:
city: Lodi
country: Italy
facility: Cardiology
state: Milan
Study officials:
affiliation: Università degli Studi di Pavia
name: Federica Dellafiore
role: PRINCIPAL_INVESTIGATOR
References: