An interventional study of Motivational interviewing performed remotely through videocalls in Heart Failure, sponsored by University of Rome Tor Vergata. Status unknown at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-11-08.
Sponsored by University of Rome Tor Vergata · Not applicable, Interventional, and Supportive care
The purpose of this study is to evaluate if motivational interviewing, performed remotely through videocalls, is effective to improve self-care in patients with heart failure
After signing the informed consent form, patients with heart failure will be assigned to the intervention or control group (1:1). The intervention group will receive a total of seven motivational interviewing sessions over 12 months. The control group will receive the standard care.
5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.
This study's planned enrollment of 432 is above the median of 72 across 3,736 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →University of Rome Tor Vergata is the lead sponsor of 94 studies on the registry; 20 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
This Arm will receive a remote intervention (via videacalls) based on motivational interviewing to improve self-care. The intervention will be delivered seven time over 12 months.
Behavioral: Motivational interviewing performed remotely through videocalls
This Arm will receive the standard of care.
Remote motivational interviewing will be performed seven time over 12 months, through videocalls. The first four interventions will be performed within two months and the following three will be performed at five, eight and eleven months from enrollment.
Self-care maintenance
Self-care maintenance will be measured with the Self-Care Maintenance Scale of the Self-Care of Heart Failure Index v.7.2
Time frame: 3 months from enrollment
Self-care maintenance
Self-care maintenance will be measured with the Self-Care Maintenance Scale of the Self-Care of Heart Failure Index v.7.2
Time frame: 6, 9 and 12 months from enrollment
Self-care monitoring
Self-care monitoring will be measured with the Self-Care Monitoring Scale of the Self-Care of Heart Failure Index v.7.2
Time frame: 3, 6, 9 and 12 months from enrollment
Self-care management
Self-care monitoring will be measured with the Self-Care Management Scale of the Self-Care of Heart Failure Index v.7.2
Time frame: 3, 6, 9 and 12 months from enrollment
Self-Care Self-Efficacy levels
Self-Care Self-Efficacy will be measured with the Self-Care Self-Efficacy Scale; this scale gives a score from 0 to 100 with higher score meaning higher self-care self-efficacy
Time frame: 3, 6, 9 and 12 months from enrollment
Burden of heart failure physical symptoms
The burden of heart failure physical symptom will be measured with the Heart Failure Somatic Perception Scale
Time frame: 3, 6, 9 and 12 months from enrollment
Disease specific quality of life
The disease-specific quality of life will be measured with the Kansas City Cardiomyopathy Questionnaire
Time frame: 3, 6, 9 and 12 months from enrollment
Caregiver contribution to heart failure self-care
Will be evaluated with the Caregiver Contribution to Self-Care of Heart Failure Index 2
Time frame: 3, 6, 9 and 12 months from enrollment
Caregiver preparedness
Will be evaluated with the Caregiver Preparedness Scale
Time frame: 3, 6, 9 and 12 months from enrollment
Caregiver burden
Will be evaluated with the Caregiver Burden Inventory
Time frame: 3, 6, 9 and 12 months from enrollment
Health care service uses
They will be evaluated with a questionnaire developed by the research team. Specifically wi will evaluate patient mortality, hospitalizations and used of emergency services.
Time frame: 3, 6, 9 and 12 months from enrollment
Patient and caregiver generic quality of life
Generic quality of live in patients and in caregivers will be evaluated with the SF-12 Survey
Time frame: 3, 6, 9 and 12 months from enrollment
Patient and caregiver anxiety and depression
They will ve evaluated with the Hospital Anxiety and Depression Scale
Time frame: 3, 6, 9 and 12 months from enrollment
Naturalistic decision making of patients and caregivers
They will be evaluated with the Naturalistic Decision Making Scale (patient and caregiver version)
Time frame: 3, 6, 9 and 12 months from enrollment
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.
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University of Rome Tor Vergata