Evaluation of Remote Motivational Interviewing for Disease Management in Heart Failure Patients and Their Carers
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Remote Motivational Interviewing, Standard Heart Failure Care.
- Who it may be relevant to
- Registry conditions: Heart Failure (HF), Self Care, Caregiver, Motivational Interviewing (MI). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Poland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
REMIND HF - Evaluation of Remote Motivational Interviewing for Disease Management in Heart Failure Patients and Their Carers
Overview
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.
Detailed description
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.
Interventions
- Behavioral Remote Motivational Interviewing
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 - Other Standard Heart Failure Care
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.
Primary outcome measures
- Change from Baseline in Patient Self-Care as Measured by the Self-Care of Heart Failure Index [Time frame: From baseline to 12 months after enrollment.]
Secondary outcome measures (8)
- Change from Baseline in Health-Related Quality of Life as Measured by the SF-12v2 Health Survey [Time frame: 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) [Time frame: 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) [Time frame: 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). [Time frame: From baseline to 12 months after enrollment.]
- Number of Heart Failure-Related Hospitalizations [Time frame: From enrollment to 12 months after enrollment.]
- Change from Baseline in Caregiver Contribution to Patient Self-Care [Time frame: From baseline to 12 months after enrollment.]
- All-Cause Mortality [Time frame: From enrollment to 12 months after enrollment.]
- Incremental Cost-Effectiveness of Remote Motivational Interviewing Compared to Standard Care [Time frame: From enrollment to 12 months after enrollment.]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
Poland · 1 center
- University Clinical Hospital in Wroclaw — Wroclaw
Identifiers
NCT: NCT07413419 · 2024/53/B/NZ7/01133 · 2024/53/B/NZ7/01133