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Clinical Trials/NCT02894502
NCT02894502
Completed
Not Applicable

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

University of Rome Tor Vergata1 site in 1 country510 target enrollmentJune 2014
ConditionsHeart Failure

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Heart Failure
Sponsor
University of Rome Tor Vergata
Enrollment
510
Locations
1
Primary Endpoint
Self-care Maintenance in Patients
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
June 2014
End Date
October 2018
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University of Rome Tor Vergata
Responsible Party
Principal Investigator
Principal Investigator

Ercole Vellone

Assistant Professor

University of Rome Tor Vergata

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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

  • Patient HF Specific Quality of Life(3, 6, 9 and 12 months from the intervention)
  • Patient and Caregiver Quality of Nocturnal Sleep(3, 6, 9 and 12 months from the intervention)
  • Caregiver Preparedness(3, 6, 9 and 12 months from the intervention)
  • Patient and Caregiver Generic Physical and Mental Quality of Life(3, 6, 9 and 12 months from the intervention)
  • Burden of HF Symptoms in Patients(3, 6, 9 and 12 months from the intervention)
  • Patient and Caregiver Anxiety and Depression(3, 6, 9 and 12 months from the intervention)
  • Patient and Caregiver Mutuality(3, 6, 9 and 12 months from the intervention)
  • Caregiver Perceived Social Support(3, 6, 9 and 12 months from the intervention)
  • Death(3, 6, 9 and 12 months from the intervention)
  • Patient Hospitalizations(3, 6, 9 and 12 months from the intervention)
  • Use of Emergency Services(3, 6, 9 and 12 months from the intervention)

Study Sites (1)

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