An interventional study of Motivational Interviewing in Heart Failure, sponsored by Azienda Socio Sanitaria Territoriale di Lodi. Completed at 1 site in Italy. Per ClinicalTrials.gov, last updated 2023-01-26.
Sponsored by Azienda Socio Sanitaria Territoriale di Lodi · Not applicable, Interventional, and Supportive care
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.
6,331 studies on the registry are indexed under Heart Failure; 1,396 are open to participants now.
This study's enrollment of 180 is above the median of 76 across 4,049 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →Azienda Socio Sanitaria Territoriale di Lodi is the lead sponsor of 5 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The dyads will receive traditional educational treatment only and will complete the questionnaires after 3, 6, 9 and 12 months follow-up post-intervention. Enrolled dyads will be monitored by the research team responsible for recruitment and follow-up.
MI intervention will be administered to patients only and caregivers will receive standard education. The intervention will last approximately 30 minutes. Thereafter, the nurse who performed the MI will contact the patients over the phone 3 times during the first 2 months after MI, to strengthen the intervention. Then, the intervention will be employed again after 3, 6, 9 and 12 months from enrolment. After each MI session, both patients and caregivers will be asked to complete the questionnaires of follow-up post-intervention
Behavioral: Motivational Interviewing
MI intervention will be administered both to patients and caregivers. The intervention will be administered to the dyad in one session and patients and their caregivers will receive the reinforcing educational treatment calibrated on the specific lacking areas of patients' self-care behaviours. After each MI session, both patients and caregivers will be asked to complete the questionnaires of follow-up post-intervention.
Behavioral: Motivational 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.
Changes will be assessed in the Level of self-care maintenance - Self-Care of Heart Failure Index 6.2
self-care behavior consisting in keeping the disease stable
Time frame: 3, 6, 9, and 12 months from the enrollment
Changes will be assessed in the Level of caregivers' involvement - Caregiver Contribution to Self-care of Heart Failure Index (CC-SCHFI)
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
Time frame: 3, 6, 9, and 12 months from the enrollment
Changes will be assessed in the Level of patient's ability to feel the symptoms of HF - Heart Failure Somatic Perception Scale (HFSPS)
patient's ability perceive the symptoms of HF
Time frame: 3, 6, 9, and 12 months from the enrollment
Changes will be assessed in the Level of cognitive impairment- Six Item Screener
patients' cognitive impairment
Time frame: 3, 6, 9, and 12 months from the enrollment
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)
HF-specific QoL
Time frame: 3, 6, 9, and 12 months from the enrollment
Changes will be assessed in the Level of feeling of intimacy and positive relationship between patient and caregiver -Mutuality Scale (MS)
feeling of intimacy and positive relationship between patient and caregiver
Time frame: 3, 6, 9, and 12 months from the enrollment
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
generic health-related QoL
Time frame: 3, 6, 9, and 12 months from the enrollment
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)
sleep quality
Time frame: 3, 6, 9, and 12 months from the enrollment
Changes will be assessed in the Level of depression and anxiety - Hospital Anxiety and Depression Scale (HADS)
depression and anxiety
Time frame: 3, 6, 9, and 12 months from the enrollment
Changes will be assessed in the Level of cognitive impairment - Montreal Cognitive Assessment (MoCA)
mild cognitive impairment
Time frame: 3, 6, 9, and 12 months from the enrollment
Changes will be assessed in the Number of comorbidities - Charlson Comorbidity Index (CCI)
comorbidities
Time frame: 3, 6, 9, and 12 months from the enrollment
Changes will be assessed in the Level of caregiver contribution to self-care - Caregiver Contribution to Self-care of Heart Failure Index (CC-SCHFI)
caregiver contribution to self-care in patients with HF
Time frame: 3, 6, 9, and 12 months from the enrollment
Changes will be assessed in the Level of caregiver Preparedness - Caregiver Preparedness Scale (CPS)
Caregiver Preparedness to care
Time frame: 3, 6, 9, and 12 months from the enrollment
Changes will be assessed in the Level of social support - Multidimensional Scale of Perceived Social Support (MSPSS)
level of social support perceived by HF patients in managing the disease
Time frame: 3, 6, 9, and 12 months from the enrollment
Plan to share: Undecided — raw data sharing
No publications or documents are linked to this record.
Ran from May 2017 to primary completion in May 2020, 36 months.
Of 1,118 non-industry interventional studies with no phase under Heart Failure, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 50. This study's 36 months is above that.
Counting every sponsor, half of 1,354 studies reached it within 31 months; a quarter within 16 and three quarters within 52.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Azienda Socio Sanitaria Territoriale di Lodi