Evaluation of Remote Motivational Interviewing for Disease Management in Heart Failure Patients and Their Carers

Background and Rationale:

Heart failure is a chronic, progressive, and life-limiting syndrome characterized by frequent hospitalizations, reduced quality of life, and high mortality. Despite advances in pharmacological and device-based treatments, effective disease management continues to rely heavily on the patient's and caregiver's ability to perform adequate self-care behaviors. These include medication adherence, symptom monitoring, dietary control, physical activity, and timely medical contact in case of deterioration.

Numerous studies demonstrate that self-care in HF remains suboptimal. Poor adherence is often related to low health literacy, cognitive decline, depression, or limited support from family and healthcare providers. Informal caregivers play a central role in assisting patients, yet they experience significant burden, anxiety, and uncertainty regarding effective disease management. Interventions aimed at improving both patient and caregiver engagement are critical for better health outcomes.

Motivational interviewing is a structured, patient-centered counseling technique designed to enhance intrinsic motivation for behavior change by exploring ambivalence and strengthening commitment. MI has been successfully applied in chronic disease management and has shown promise in improving self-care and adherence in cardiovascular populations. Remote delivery of MI using telecommunication tools can increase accessibility, continuity, and cost-effectiveness of support for patients with heart failure.

The REMIND HF study has been developed to evaluate the efficacy of remote nurse-delivered motivational interviewing in improving self-care behaviors among patients with heart failure and their informal caregivers. The project is conducted at the Wroclaw Medical University (Poland) and funded by the National Science Centre (NCN, OPUS 27 grant).

Objectives and Hypotheses:

The primary objective is to determine whether remote motivational interviewing enhances self-care behaviors in patients with chronic heart failure compared with standard care.

Secondary objectives are to examine the effects of the intervention on:

* Quality of life in patients and caregivers. * Anxiety and depression in patients and caregivers. * Caregiver contribution to patient self-care and perceived burden. * Healthcare utilization (hospitalizations and emergency visits). * Cost-effectiveness of the intervention.

Hypothesis: Participants receiving the remote MI intervention will demonstrate improved self-care (based on Self-Care of Heart Failure Index - SCHFI), greater caregiver contribution (based on Caregiver Contribution to Self-Care of Heart Failure Index - CCSCHFI), and better quality of life than those receiving standard care.

Study Design:

The REMIND HF study is a randomized, controlled, two-arm interventional trial using a parallel assignment model. Participants will be allocated in a 1:1 ratio to either the intervention (remote MI) or control (standard care) group.

Study Type: Interventional (Behavioral)

Allocation: Randomized

Intervention Model: Parallel Assignment

Masking: None (Open Label)

Primary Purpose: Supportive / Behavioral Intervention

Sample Size: 600 participants (300 HF patients and 300 caregivers)

Duration: 12 months per dyad (baseline, 3-month, 6-month, 9- month and 12-months after the end of the study)

Recruitment will take place at the Clinical University Hospital in Wroclaw. The study is coordinated by the Department of Clinical Nursing at the Wroclaw Medical University in collaboration with the University of Rome Tor Vergata.

Intervention Description:

Intervention Arm (Remote Motivational Interviewing):

Participants receive a structured program of seven remote motivational interviewing sessions delivered by trained nurses over 12 months using a secure video platform. Each session lasts 45-60 minutes and follows a standardized manual. Core session topics include:

Baseline assessment and motivation building.

Goal setting and overcoming ambivalence.

Medication adherence and symptom monitoring.

Diet and physical activity optimization.

Stress management and coping strategies.

Strengthening communication within the patient-caregiver dyad.

Maintenance of behavior change and self-efficacy.

Control Arm (Standard Care):

Participants receive routine medical care and standard HF education consistent with European Society of Cardiology (ESC) guidelines, without motivational interviewing.

Data Collection and Instruments:

Data are collected at baseline, 3 months, 6 months, 9 months and 12 months after the end of the study .

* Self-Care of Heart Failure Index (SCHFI) - primary outcome, assessing self-care maintenance, management, and confidence. * Caregiver Contribution to Self-Care of Heart Failure Index (CCSCHFI) - assessment of caregiver engagement and support in patient self-care. * Kansas City Cardiomyopathy Questionnaire (KCCQ) and Short Form 12 (SF-12) - patient and caregiver quality of life. * Hospital Anxiety and Depression Scale (HADS) - emotional well-being of patients and caregivers. * Clinical data - NYHA class, comorbidities, hospital admissions, and mortality.

All data are entered into a secure electronic case report form (eCRF) hosted on password-protected university servers. Data integrity and completeness are verified via built-in validation checks.

Quality Assurance and Data Management:

A detailed quality assurance (QA) plan governs all study operations. It includes:

Validation checks within the eCRF to ensure internal data consistency.

Cross-verification of clinical and self-reported data at each follow-up.

• Change from Baseline in Health-Related Quality of Life as Measured by the SF-12v2 Health Survey [Срок оценки: From baseline to 12 months after enrollment.]
• Change from Baseline in Heart Failure-Specific Quality of Life as Measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ) [Срок оценки: From baseline to 12 months after enrollment.]
• Change from Baseline in Anxiety Symptoms as Measured by the Hospital Anxiety and Depression Scale - Anxiety Subscale (HADS-A) [Срок оценки: From baseline to 12 months after enrollment.]
• Change from Baseline in Depressive Symptoms as Measured by the Hospital Anxiety and Depression Scale - Depression Subscale (HADS-D). [Срок оценки: From baseline to 12 months after enrollment.]
• Number of Heart Failure-Related Hospitalizations [Срок оценки: From enrollment to 12 months after enrollment.]
• Change from Baseline in Caregiver Contribution to Patient Self-Care [Срок оценки: From baseline to 12 months after enrollment.]
• All-Cause Mortality [Срок оценки: From enrollment to 12 months after enrollment.]
• Incremental Cost-Effectiveness of Remote Motivational Interviewing Compared to Standard Care [Срок оценки: From enrollment to 12 months after enrollment.]