MOTIVATional intErviewing to Improve Self-care in Heart Failure Patients

Study Overview
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Brief Summary
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The aims of this study will be to evaluate the effect of motivational interviewing (MI) to improve self-care in heart failure (HF) patients and caregiver contributions to HF self-care. Also this study will evaluate the effect of MI on the following secondary outcomes: In HF patients: HF somatic symptom perception, generic and specific quality of life, anxiety and depression, sleep quality, mutuality with caregiver, hospitalizations, use of emergency services, and mortality; In caregivers: generic quality of life, anxiety and depression, mutuality with patient, preparedness, social support and sleep quality.

Official Title
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MOTIVATional intErviewing to Improve Self-care in Heart Failure Patients (MOTIVATE-HF): Study Protocol of a Three-arm Multicenter Randomized Controlled Trial

Conditions
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Heart Failure

Intervention / Treatment
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* Behavioral: Motivational interviewing


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Diagnosis of HF (for patient), New York Heart Association (NYHA) functional class II- IV (for patient), Inadequate self-care assessed with the Self-Care Heart Failure Index (for patient), Being the informal caregiver of the patients (for caregiver). Exclusion criteria: Severe cognitive impairment evaluated with the Six-item screener (for patient), Acute coronary syndrome during the last three months (for patient), Living in a residential settings (e.g., nursing home) (for patient), Patients not willing to participate in the study (for caregiver).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Motivational interviewing only for patients<br>In this arm the interventions will be delivered only to patients | Behavioral: Motivational interviewing<br>* The intervention will consist of a brief session of motivational interviewing (MI) performed by a trained nurse. During MI, the interventionist will address one or two aspects of self-care that the participants want to address. After this first intervention, the same interventionist will contact the participant by telephone to improve the first intervention and provide further support as needed. These telephone contact will be done three times at two week intervals following the first intervention (for a total of two months). Patients and caregivers that receive the intervention also will be given informational material on HF management that is consistent with international guidelines.<br>|
| Experimental: Motivational interviewing to patients and caregivers<br>In this arm the interventions will be delivered both to patients and caregivers | Behavioral: Motivational interviewing<br>* The intervention will consist of a brief session of motivational interviewing (MI) performed by a trained nurse. During MI, the interventionist will address one or two aspects of self-care that the participants want to address. After this first intervention, the same interventionist will contact the participant by telephone to improve the first intervention and provide further support as needed. These telephone contact will be done three times at two week intervals following the first intervention (for a total of two months). Patients and caregivers that receive the intervention also will be given informational material on HF management that is consistent with international guidelines.<br>|
| No Intervention: Control group<br>This Group will receive the usual care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-care Maintenance in Patients | Self-care in HF patients will be measured with the Self-Care of HF Index V.6.2. Since this instrument has three separate scales, we considered as a primary outcome the score of the Self-care Maintenance scale. The Self-Care Maintenance scale has a score between 0 and 100 with higher score meaning better self-care. Self-Care Maintenance is considered adequate when the score is at least 70. | 3 months from the intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Burden of HF Symptoms in Patients | Burden of HF symptoms will be measured with the Heart Failure Somatic Perception Scale (HFSPS). The HFSPS has a range score between 0 and 90; the higher the score, the higher the burden of symptoms caused by heart failure. | 3, 6, 9 and 12 months from the intervention | 
| Patient and Caregiver Generic Physical and Mental Quality of Life | Patient and caregiver generic physical and mental quality of life will be assessed with the Short Form 12 (SF-12). | 3, 6, 9 and 12 months from the intervention | 
| Patient and Caregiver Anxiety and Depression | Patient and caregiver anxiety and depression will be evaluated with the Hospital Anxiety and Depression Scale | 3, 6, 9 and 12 months from the intervention | 
| Patient HF Specific Quality of Life | Patient HF specific quality of life will be evaluated with the Kansas City Cardiomyopathy Questionnaire | 3, 6, 9 and 12 months from the intervention | 
| Patient and Caregiver Quality of Nocturnal Sleep | We will use the Pittsburgh Sleep Quality Index | 3, 6, 9 and 12 months from the intervention | 
| Patient and Caregiver Mutuality | We will use the Mutuality Scale | 3, 6, 9 and 12 months from the intervention | 
| Caregiver Preparedness | Caregiver Preparedness will be evaluated with the Caregiver Preparedness Scale | 3, 6, 9 and 12 months from the intervention | 
| Caregiver Perceived Social Support | We will use the Multidimensional Scale of Perceived Social Support Scale | 3, 6, 9 and 12 months from the intervention | 
| Patient Hospitalizations | The number of patient hospitalizations will be measured asking the caregiver how many time the patient was hospitalized from at 3, 6, 9 and 12 months from the intervention. | 3, 6, 9 and 12 months from the intervention | 
| Use of Emergency Services | How many times the patient has used the emergency services will be evaluated by asking the caregiver how many time the patient used after 3, 6, 9 and 12 months from the intervention. | 3, 6, 9 and 12 months from the intervention | 
| Death | Death rates will be evaluated in the three arms of the study by caregiver interview at 3, 6, 9 and 12 months from the intervention. | 3, 6, 9 and 12 months from the intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Self-care, Motivational interviewing, Heart failure, Caregivers