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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorWroclaw Medical University

About this trial

Heart failure (HF) is a chronic and progressive condition that significantly affects patients' quality of life and increases the burden on family caregivers. Many patients struggle with self-care, including medication adherence, diet, and symptom monitoring.

The REMIND HF (REmote Motivational INterviewing for Disease Management in Heart Failure) study aims to evaluate the effectiveness of remote motivational interviewing (MI) as a behavioral intervention to improve disease management and self-care among heart failure patients and their informal caregivers. The intervention consists of a series of online motivational interviews conducted by trained nurses over a 12-month period, focusing on lifestyle modification, self-monitoring, and patient-caregiver cooperation.

The study will be conducted at the Wroclaw Medical University and collaborating centers. It will enroll 300 patients with heart failure (The New York Heart Association Functional Classificaion - NYHA class: II-IV) and their primary caregivers. Outcomes will include self-care behaviors, quality of life, psychological well-being, and health service utilization. The results will contribute to developing accessible, patient-centered models of heart failure management based on telehealth and behavioral support.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult patients aged 18 years or older.

Diagnosis of heart failure.

New York Heart Association (NYHA) functional class II-IV.

Poor self-care as assessed at baseline.

Disqualifiers

Severe cognitive impairment that would limit the ability to participate in the intervention or complete study assessments.

Acute coronary syndrome or other acute cardiac event within the last 3 months.

Residence in a nursing home or long-term care facility.

Inability to participate in videoconferencing sessions.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Remote Motivational Interviewing

    Behavioral

    Remote motivational interviewing is a structured behavioral intervention delivered by trained nurses via secure videoconferencing. The intervention consists of seven individual motivational interviewing sessions provided over a 12-month period, conducted according to established motivational interviewing principles. Sessions are tailored to individual patient-caregiver dyads and aim to enhance heart failure self-care behaviors and caregiver contribution to self-care, including symptom monitoring, medication adherence, lifestyle modification, and daily disease management. The intervention also addresses motivation, confidence, and problem-solving related to long-term self-care. Remote motivational interviewing is delivered in addition to standard heart failure care and does not replace routine clinical management.

  • Standard Heart Failure Care

    Other intervention

    Standard heart failure care provided according to routine clinical practice and current guideline-based management, which may include outpatient follow-up, pharmacological treatment optimization, patient education, and access to usual healthcare services. No motivational interviewing sessions are provided as part of standard care.

Treatment groups

600 Participants
are divided into 2 treatment groups
Group A: Remote Motivational Interviewing plus Standard CareExperimental treatment 1 intervention
Group B: Standard CareActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change from Baseline in Patient Self-Care as Measured by the Self-Care of Heart Failure Index

Patient self-care will be assessed using the Self-Care of Heart Failure Index (SCHFI). The SCHFI is a validated questionnaire that evaluates heart failure self-care behaviors across three domains: self-care maintenance, self-care management, and self-care confidence. Each domain score is standardized on a 0-100 scale, with higher scores indicating better self-care. Change from baseline in SCHFI scores will be analyzed to assess the effect of the intervention.

Time frame
From baseline to 12 months after enrollment.

Secondary outcomes

1

Change from Baseline in Health-Related Quality of Life as Measured by the SF-12v2 Health Survey

Health-related quality of life will be measured using the SF-12v2 Health Survey, which generates physical and mental component summary scores. Scores are norm-based, with higher scores indicating better health-related quality of life. Change from baseline will be assessed.

Time frame
From baseline to 12 months after enrollment.
2

Change from Baseline in Heart Failure-Specific Quality of Life as Measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ)

Heart failure-specific quality of life will be assessed using the Kansas City Cardiomyopathy Questionnaire (KCCQ). Scores range from 0 to 100, with higher scores indicating better health status and quality of life. Change from baseline will be analyzed.

Time frame
From baseline to 12 months after enrollment.
3

Change from Baseline in Anxiety Symptoms as Measured by the Hospital Anxiety and Depression Scale - Anxiety Subscale (HADS-A)

Anxiety symptoms will be assessed using the anxiety subscale of the Hospital Anxiety and Depression Scale (HADS-A), a validated self-report questionnaire. The HADS-A subscale consists of 7 items, with total scores ranging from 0 to 21. Higher scores indicate greater severity of anxiety symptoms. Change from baseline in HADS-A scores will be analyzed to assess the effect of the intervention.

Time frame
From baseline to 12 months after enrollment.
4

Change from Baseline in Depressive Symptoms as Measured by the Hospital Anxiety and Depression Scale - Depression Subscale (HADS-D).

Depressive symptoms will be assessed using the depression subscale of the Hospital Anxiety and Depression Scale (HADS-D), a validated self-report questionnaire. The HADS-D subscale consists of 7 items, with total scores ranging from 0 to 21. Higher scores indicate greater severity of depressive symptoms. Change from baseline in HADS-D scores will be analyzed to assess the effect of the intervention.

Time frame
From baseline to 12 months after enrollment.

Other outcomes

Sponsors and contacts

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Wroclaw Medical University

Lead sponsor

University of Rome Tor Vergata

Collaborator

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