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

NCT07413419 | Not Yet Recruiting

• 1 other identifier: 2024/53/B/NZ7/01133
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

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)

Keywords

heart failure; Self-Care; Motivational Interviewing; caregivers; telehealth; nursing

Outcome Measures

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.

  From baseline to 12 months after enrollment.

Secondary Outcomes (8)

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

  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)

  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)

  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).

  From baseline to 12 months after enrollment.

• Number of Heart Failure-Related Hospitalizations

  From enrollment to 12 months after enrollment.

Study Arms (2)

Remote Motivational Interviewing plus Standard Care

EXPERIMENTAL

Participants assigned to this arm will receive remote motivational interviewing delivered via secure videoconferencing in addition to standard heart failure care. The intervention will consist of seven motivational interviewing sessions provided over a 12-month period by trained nurses. Sessions will focus on supporting patient self-care behaviors and caregiver contribution to self-care, including symptom monitoring, medication adherence, lifestyle behaviors, and disease management. Participants will continue to receive all components of usual heart failure care throughout the study.

Behavioral: Remote Motivational Interviewing

Standard Care

ACTIVE COMPARATOR

Participants assigned to this arm will receive standard heart failure care in accordance with current clinical guidelines. Standard care may include routine outpatient follow-up, pharmacological treatment, patient education, and access to usual healthcare services, without additional motivational interviewing sessions.

Other: Standard Heart Failure Care

Interventions

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.

Remote Motivational Interviewing plus Standard Care

Standard Heart Failure Care OTHER

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.

Standard Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Receiving care at the participating heart failure clinic.
• Access to the internet and a device capable of videoconferencing.
• Ability to understand the study procedures and provide written informed consent.
• Having an identified primary informal caregiver willing to participate in the study.
• Informal caregivers aged 18 years or older.
• Caregivers identified by the patient as the primary person providing unpaid support in daily disease management.
• Caregivers able to understand the study procedures and provide written informed consent.

You may not qualify if:

• 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.
• Participation in another interventional study that could interfere with the outcomes of this trial.

Sponsors & Collaborators

• Wroclaw Medical University: lead
• University of Rome Tor Vergata: collaborator

Study Sites (1)

University Clinical Hospital in Wroclaw

Wroclaw, 51-618, Poland

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Izabella Uchmanowicz, Professor, PhD

  Wroclaw Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Izabella Uchmanowicz, Professor, PhD

CONTACT

0048 71 784 18 24; izabella.uchmanowicz@umw.edu.pl

Marta Wleklik, PhD

CONTACT

0048 71 784 18 24; marta.wleklik@umw.edu.pl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This is an open-label study. Due to the behavioral nature of the intervention, neither participants, care providers, investigators, nor outcome assessors are blinded to group assignment.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 22, 2026
• First Posted: February 17, 2026
• Study Start: February 28, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): January 30, 2028
• Last Updated: February 17, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 6 months after publication of the primary results and available for a period of 5 years.
• Access Criteria: De-identified individual participant data and supporting documentation will be shared with qualified researchers who submit a reasonable request. Requests must include a methodologically sound research proposal describing the planned analyses. Proposals will be reviewed by the study investigators for scientific merit and compliance with ethical and data protection requirements. Access to data will be granted after approval of the proposal and completion of a data use agreement. Data will be shared through secure data transfer methods and will be used solely for the approved research purposes.

Locations

PL (1)