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Completed

NCT Number: NCT02894502

MOTIVATional intErviewing to Improve Self-care in Heart Failure Patients

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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Rome Tor Vergata

Rome, 00135, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Motivational Interviewing

Behavioral

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.

Primary outcomes

  1. Self-care Maintenance in Patients

    Time frame: 3 months from the intervention

    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.

Secondary outcomes

  1. Burden of HF Symptoms in Patients

    Time frame: 3, 6, 9 and 12 months from the intervention

    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.

  2. Patient and Caregiver Generic Physical and Mental Quality of Life

    Time frame: 3, 6, 9 and 12 months from the intervention

    Patient and caregiver generic physical and mental quality of life will be assessed with the Short Form 12 (SF-12).

  3. Patient and Caregiver Anxiety and Depression

    Time frame: 3, 6, 9 and 12 months from the intervention

    Patient and caregiver anxiety and depression will be evaluated with the Hospital Anxiety and Depression Scale

  4. Patient HF Specific Quality of Life

    Time frame: 3, 6, 9 and 12 months from the intervention

    Patient HF specific quality of life will be evaluated with the Kansas City Cardiomyopathy Questionnaire

  5. Patient and Caregiver Quality of Nocturnal Sleep

    Time frame: 3, 6, 9 and 12 months from the intervention

    We will use the Pittsburgh Sleep Quality Index

  6. Patient and Caregiver Mutuality

    Time frame: 3, 6, 9 and 12 months from the intervention

    We will use the Mutuality Scale

  7. Caregiver Preparedness

    Time frame: 3, 6, 9 and 12 months from the intervention

    Caregiver Preparedness will be evaluated with the Caregiver Preparedness Scale

  8. Caregiver Perceived Social Support

    Time frame: 3, 6, 9 and 12 months from the intervention

    We will use the Multidimensional Scale of Perceived Social Support Scale

  9. Patient Hospitalizations

    Time frame: 3, 6, 9 and 12 months from the intervention

    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.

  10. Use of Emergency Services

    Time frame: 3, 6, 9 and 12 months from the intervention

    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.

  11. Death

    Time frame: 3, 6, 9 and 12 months from the intervention

    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.

Sponsors and collaborators

Lead sponsor

University of Rome Tor Vergata

Other

Collaborators

  • Center of Excellence for Nursing Scholarship

Registry information

Official study title

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

Acronym: MOTIVATE-HF

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Sep 9, 2016
Registry last updated
Mar 17, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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