System Maintenance Notice

Please note that maintenance work is scheduled between 4 AM and 5 AM - CET. During this time, you may experience reduced performance. Thanks for your patience.

Studies

Interventional Not yet recruiting

NCT07413419 on ClinicalTrials.gov

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

Official title: REMIND HF - Evaluation of Remote Motivational Interviewing for Disease Management in Heart Failure Patients and Their Carers

  • Sponsor: Wrocław Medical University
  • Collaborators: University of Rome Tor Vergata
  • Enrollment: 600 (Estimated)
  • Study start: 2026-02-28 (Estimated)
  • Primary completion: 2027-12-31 (Estimated)
  • Study completion: 2028-01-30 (Estimated)
  • Allocation: Randomized
  • InterventionModel: Parallel
  • InterventionModelDescription: This is a two-arm, parallel-group randomized controlled trial. Patient-caregiver dyads will be randomly assigned in a 1:1 ratio to either an experimental arm or a control arm. The experimental arm will receive remote motivational interviewing delivered via secure videoconferencing in addition to standard heart failure care, while the control arm will receive standard heart failure care alone. Randomization will occur at the level of the patient-caregiver dyad, and participants will remain in their assigned study arm for the entire duration of the study. Outcomes will be assessed at baseline and during follow-up visits at 3, 6, 9, and 12 months after enrollment.
  • Masking: None
  • PrimaryPurpose: Supportive Care

Brief Summary

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.

Conditions

  • Heart Failure (HF)
  • Self Care
  • Caregiver
  • Motivational Interviewing (MI)

Intervention / Treatment

  • Behavioral: Remote Motivational Interviewing
  • Other: Standard Heart Failure Care

Primary Outcome Measures

  • Change from Baseline in Patient Self-Care as Measured by the Self-Care of Heart Failure Index (From baseline to 12 months after enrollment.)
    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.

Countries

Poland

Locations and Investigators

  • University Clinical Hospital in Wroclaw, Wroclaw, Poland
    • Izabella Uchmanowicz, Professor, PhD

Study Officials