Heart Failure (HF)REMIND-HFNCT07413419
Evaluation of Remote Motivational Interviewing for Disease Management in Heart Failure Patients and Their Carers
A study testing Remote Motivational Interviewing and Standard Heart Failure Care in people with Heart Failure (HF) and Self Care, run by Wroclaw Medical University at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure (HF), Self Care, Caregiver
- What is being tested?
- Remote Motivational Interviewing and Standard Heart Failure Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 sitePoland
- Study dates
- 28 Feb 2026to 30 Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 11Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site
University Clinical Hospital in Wroclaw
Wroclaw, 51-618
Izabella Uchmanowicz, Professor, PhD, 0048 71 784 18 24, izabella.uchmanowicz@umw.edu.pl
About this study
Official title: REMIND HF - Evaluation of Remote Motivational Interviewing for Disease Management in Heart Failure Patients and Their Carers
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.
Read the 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.
Periodic on-site audits by the study coordinator to verify consent forms and data accuracy.
Maintenance of a data dictionary describing each variable, coding scheme, and reference range.
Standard Operating Procedures (SOPs) covering recruitment, data entry, data monitoring, and corrective actions.
Annual data review by an independent statistician to confirm representativeness and data quality.
Source Data Verification:
Data will be periodically compared with hospital medical records and participant source documents to ensure completeness and accuracy.
Missing Data Management:
Missing or inconsistent data will be tracked automatically in the database. For analyses, multiple imputation will be used when appropriate.
Statistical Analysis Plan:
Statistical analysis will be carried out with the use of R, Python, and their packages. Inference will be frequentist, based on α = 0.05. Depending on the distribution and scale of the variables (assessed using graphical methods and tests of normality), descriptive statistics will include means with standard deviations or medians with interquartile ranges. Group comparisons will be performed using standard parametric or non-parametric tests, as appropriate, and ANOVA (with post-hoc procedures) for multi-group comparisons. Primary analyses will use mixed-effects models for repeated measures with fixed effects for treatment group, time, and their interaction, adjusting for key covariates. Random effects will account for within-participant correlation; additional clustering (e.g., by interventionist or within patient-caregiver dyads) will be accommodated if present. Time will be modelled as a categorical or continuous variable depending on the distribution of the data and the clinical relevance of the chosen parametrization. Although beta distribution fits these scores based on the presence of floor and ceiling scores (0 and 100%), the choice of distribution will be assessed using information criteria (Akaike Information Criterion- AIC/ Bayesian Information Criterion - BIC), residual diagnostics, and graphical inspection. Upon presence of zeroes in scoring, the use of zero-inflated GLMMs will be considered. Interaction analysis will be carried out so as to further explore the data. If multiple multivariate models are developed, they will be compared in terms of their goodness of fit. Model selection strategies (e.g., penalization or stepwise procedures) will be considered for exploratory multivariate analyses. All necessary statistical assumptions will be thoroughly tested, with appropriate statistical tests. All analyses will be conducted under the intention-to-treat principle, and secondary analyses will be considered exploratory without adjustment for multiplicity unless otherwise specified.
If a minimal clinically important difference (MCID) for the primary/secondary questionnaire scores can be defined based on existing literature, a secondary logistic regression analysis will be performed to model the probability of exceeding this threshold. Model performance will be evaluated with sensitivity, specificity, Brier score (via 10-fold cross-validation), and clinical utility will be assessed using decision curve analysis (DCA).
Ethical and Regulatory Oversight:
The protocol has been submitted to the Bioethics Committee of Wroclaw Medical University for review. Written informed consent will be obtained from all participants (patients and caregivers).
The study involves minimal risk because it is a non-invasive behavioral intervention. No drugs or devices are tested.
Data protection and confidentiality will comply with General Data Protection Regulation (GDPR) and institutional standards. Participant data will be pseudonymized, and access will be restricted to authorized personnel.
Because the study is low risk, a formal Data Safety Monitoring Board (DSMB) will not be appointed; instead, monitoring will be performed by the study steering committee under the principal investigator's supervision.
Sample Size Assessment:
Based on previous MI studies, a sample of 240 patients per group provides 80% power (α = 0.05) to detect a 10-point difference in SCHFI total score (SD = 25). Allowing for 20% attrition, 300 dyads (600 total participants) will be enrolled.
Timeline:
Study Start: February 2026 (anticipated)
Primary Completion: December 2027 (anticipated)
Study Completion: June 2028 (anticipated)
Expected Results and Significance:
The REMIND HF study is expected to demonstrate that remote motivational interviewing significantly improves self-care behaviors in HF patients and enhances caregiver contribution to disease management. Improved self-care is anticipated to reduce hospitalization rates, improve health-related quality of life, and lower healthcare costs.
Findings from this study will provide evidence supporting the integration of behavioral and telehealth interventions into standard HF management and will contribute to international research on patient-caregiver collaboration in chronic disease care
- Being tested
- Remote Motivational Interviewing, Standard Heart Failure Care
- Keywords
- heart failure, Self-Care, Motivational Interviewing, caregivers, telehealth, nursing
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote Motivational InterviewingBehavioural
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 CareOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Standard Heart Failure Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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).
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.
Measured: From baseline to 12 months after enrollment.
Number of Heart Failure-Related Hospitalizations
Healthcare utilization will be assessed as the number of heart failure-related hospitalizations occurring during the follow-up period.
Measured: From enrollment to 12 months after enrollment.
Change from Baseline in Caregiver Contribution to Patient Self-Care
Caregiver contribution to patient self-care will be assessed using a validated questionnaire measuring the caregiver's involvement in supporting heart failure self-care behaviors - Caregiver Contribution to Self-Care of Heart Failure Index (CCSCHFI) . Higher scores indicate greater caregiver contribution. Change from baseline will be analyzed.
Measured: From baseline to 12 months after enrollment.
All-Cause Mortality
All-cause mortality will be assessed as death from any cause during the study follow-up period.
Measured: From enrollment to 12 months after enrollment.
Incremental Cost-Effectiveness of Remote Motivational Interviewing Compared to Standard Care
Cost-effectiveness will be assessed from the healthcare system perspective. Direct medical costs will include costs of the intervention (staff time, training, videoconferencing) and healthcare utilization costs (hospitalizations, emergency visits, outpatient care). Health outcomes will be derived from validated quality of life measures collected during the study. Incremental cost-effectiveness ratios (ICERs), defined as the difference in costs divided by the difference in health outcomes between groups, will be calculated at 12 months.
Measured: From enrollment to 12 months after enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start28 Feb 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion30 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure (HF)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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 (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wroclaw Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Rome Tor Vergata
- Responsible party
- Sponsor
- Investigators
- Izabella Uchmanowicz, Professor, PhD, Principal investigator, Wroclaw Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07413419
- Sponsor's protocol ID
- 2024/53/B/NZ7/01133
- Other IDs
- 2024/53/B/NZ7/01133
- Acronym
- REMIND-HF
- Status last verified
- Nov 2025
- First submitted
- 22 Jan 2026
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the results reported in this study will be made available upon reasonable request. Data will be shared with qualified researchers after publication of the primary results, subject to approval of a methodologically sound research proposal and completion of a data use agreement. Shared data will not include information that could identify individual participants.
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REMIND HF - Evaluation of Remote Motivational Interviewing for Disease Management in Heart Failure Patients and Their Carers
- ClinicalTrials.gov ID
- NCT07413419
- Acronym / sponsor ID
- REMIND-HF / 2024/53/B/NZ7/01133
- Keywords
- heart failure, Self-Care, Motivational Interviewing, caregivers, telehealth, nursing
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Wroclaw Medical UniversityUniversity, hospital or other
- Collaborators
- University of Rome Tor Vergata
- Study start
- 28 Feb 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 30 Jan 2028 (estimated)
- First posted
- 17 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Periodic on-site audits by the study coordinator to verify consent forms and data accuracy.
Maintenance of a data dictionary describing each variable, coding scheme, and reference range.
Standard Operating Procedures (SOPs) covering recruitment, data entry, data monitoring, and corrective actions.
Annual data review by an independent statistician to confirm representativeness and data quality.
Source Data Verification:
Data will be periodically compared with hospital medical records and participant source documents to ensure completeness and accuracy.
Missing Data Management:
Missing or inconsistent data will be tracked automatically in the database. For analyses, multiple imputation will be used when appropriate.
Statistical Analysis Plan:
Statistical analysis will be carried out with the use of R, Python, and their packages. Inference will be frequentist, based on α = 0.05. Depending on the distribution and scale of the variables (assessed using graphical methods and tests of normality), descriptive statistics will include means with standard deviations or medians with interquartile ranges. Group comparisons will be performed using standard parametric or non-parametric tests, as appropriate, and ANOVA (with post-hoc procedures) for multi-group comparisons. Primary analyses will use mixed-effects models for repeated measures with fixed effects for treatment group, time, and their interaction, adjusting for key covariates. Random effects will account for within-participant correlation; additional clustering (e.g., by interventionist or within patient-caregiver dyads) will be accommodated if present. Time will be modelled as a categorical or continuous variable depending on the distribution of the data and the clinical relevance of the chosen parametrization. Although beta distribution fits these scores based on the presence of floor and ceiling scores (0 and 100%), the choice of distribution will be assessed using information criteria (Akaike Information Criterion- AIC/ Bayesian Information Criterion - BIC), residual diagnostics, and graphical inspection. Upon presence of zeroes in scoring, the use of zero-inflated GLMMs will be considered. Interaction analysis will be carried out so as to further explore the data. If multiple multivariate models are developed, they will be compared in terms of their goodness of fit. Model selection strategies (e.g., penalization or stepwise procedures) will be considered for exploratory multivariate analyses. All necessary statistical assumptions will be thoroughly tested, with appropriate statistical tests. All analyses will be conducted under the intention-to-treat principle, and secondary analyses will be considered exploratory without adjustment for multiplicity unless otherwise specified.
If a minimal clinically important difference (MCID) for the primary/secondary questionnaire scores can be defined based on existing literature, a secondary logistic regression analysis will be performed to model the probability of exceeding this threshold. Model performance will be evaluated with sensitivity, specificity, Brier score (via 10-fold cross-validation), and clinical utility will be assessed using decision curve analysis (DCA).
Ethical and Regulatory Oversight:
The protocol has been submitted to the Bioethics Committee of Wroclaw Medical University for review. Written informed consent will be obtained from all participants (patients and caregivers).
The study involves minimal risk because it is a non-invasive behavioral intervention. No drugs or devices are tested.
Data protection and confidentiality will comply with General Data Protection Regulation (GDPR) and institutional standards. Participant data will be pseudonymized, and access will be restricted to authorized personnel.
Because the study is low risk, a formal Data Safety Monitoring Board (DSMB) will not be appointed; instead, monitoring will be performed by the study steering committee under the principal investigator's supervision.
Sample Size Assessment:
Based on previous MI studies, a sample of 240 patients per group provides 80% power (α = 0.05) to detect a 10-point difference in SCHFI total score (SD = 25). Allowing for 20% attrition, 300 dyads (600 total participants) will be enrolled.
Timeline:
Study Start: February 2026 (anticipated)
Primary Completion: December 2027 (anticipated)
Study Completion: June 2028 (anticipated)
Expected Results and Significance:
The REMIND HF study is expected to demonstrate that remote motivational interviewing significantly improves self-care behaviors in HF patients and enhances caregiver contribution to disease management. Improved self-care is anticipated to reduce hospitalization rates, improve health-related quality of life, and lower healthcare costs.
Findings from this study will provide evidence supporting the integration of behavioral and telehealth interventions into standard HF management and will contribute to international research on patient-caregiver collaboration in chronic disease care
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Remote Motivational Interviewing plus Standard Care | Experimental | Behavioral: Remote Motivational InterviewingParticipants 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. |
| Standard Care | Active comparator | Other: Standard Heart Failure CareParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Remote Motivational InterviewingRemote 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. | Behavioural | Remote Motivational Interviewing plus Standard Care |
| Standard Heart Failure CareStandard 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. | Other | Standard Care |
Primary outcome
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.
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.
8 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the results reported in this study will be made available upon reasonable request. Data will be shared with qualified researchers after publication of the primary results, subject to approval of a methodologically sound research proposal and completion of a data use agreement. Shared data will not include information that could identify individual participants.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Izabella Uchmanowicz, Professor, PhD principal investigator
Wroclaw Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remote Motivational Interviewing and Standard Heart Failure Care in people with Heart Failure (HF) and Self Care, run by Wroclaw Medical University at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Izabella Uchmanowicz, Professor, PhD (0048 71 784 18 24, izabella.uchmanowicz@umw.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.