Clinical trial NCT02894502: MOTIVATional intErviewing to Improve Self-care in Heart Failure Patients
Official title: MOTIVATional intErviewing to Improve Self-care in Heart Failure Patients (MOTIVATE-HF): Study Protocol of a Three-arm Multicenter Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Keywords: Self-care
Motivational interviewing
Heart failure
Caregivers
Lead sponsor: University of Rome Tor Vergata
Sponsor class: OTHER
Collaborators: name: Center of Excellence for Nursing Scholarship
First posted: 2016-09-09
Enrollment: 510
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Self-care Maintenance in Patients
timeFrame: 3 months from the intervention
Secondary outcomes:
measure: Burden of HF Symptoms in Patients
timeFrame: 3, 6, 9 and 12 months from the intervention
measure: Patient and Caregiver Generic Physical and Mental Quality of Life
timeFrame: 3, 6, 9 and 12 months from the intervention
measure: Patient and Caregiver Anxiety and Depression
timeFrame: 3, 6, 9 and 12 months from the intervention
measure: Patient HF Specific Quality of Life
timeFrame: 3, 6, 9 and 12 months from the intervention
measure: Patient and Caregiver Quality of Nocturnal Sleep
timeFrame: 3, 6, 9 and 12 months from the intervention
measure: Patient and Caregiver Mutuality
timeFrame: 3, 6, 9 and 12 months from the intervention
measure: Caregiver Preparedness
timeFrame: 3, 6, 9 and 12 months from the intervention
measure: Caregiver Perceived Social Support
timeFrame: 3, 6, 9 and 12 months from the intervention
measure: Patient Hospitalizations
timeFrame: 3, 6, 9 and 12 months from the intervention
measure: Use of Emergency Services
timeFrame: 3, 6, 9 and 12 months from the intervention
measure: Death
timeFrame: 3, 6, 9 and 12 months from the intervention
Other outcomes:
Locations:
city: Rome
country: Italy
facility: University of Rome Tor Vergata
Study officials:
References:
citation: Vellone E, Paturzo M, D'Agostino F, Petruzzo A, Masci S, Ausili D, Rebora P, Alvaro R, Riegel B. MOTIVATional intErviewing to improve self-care in Heart Failure patients (MOTIVATE-HF): Study protocol of a three-arm multicenter randomized controlled trial. Contemp Clin Trials. 2017 Apr;55:34-38. doi: 10.1016/j.cct.2017.02.003. Epub 2017 Feb 7.
citation: Vellone E, Rebora P, Ausili D, Zeffiro V, Pucciarelli G, Caggianelli G, Masci S, Alvaro R, Riegel B. Motivational interviewing to improve self-care in heart failure patients (MOTIVATE-HF): a randomized controlled trial. ESC Heart Fail. 2020 Jun;7(3):1309-1318. doi: 10.1002/ehf2.12733. Epub 2020 Apr 28.
citation: Spedale V, Fabrizi D, Rebora P, Luciani M, Alvaro R, Vellone E, Riegel B, Ausili D. The Association Between Self-reported Sleep Quality and Self-care in Adults With Heart Failure: A Cross-sectional Study. J Cardiovasc Nurs. 2022 May 31. doi: 10.1097/JCN.0000000000000929. Online ahead of print.
citation: Locatelli G, Zeffiro V, Occhino G, Rebora P, Caggianelli G, Ausili D, Alvaro R, Riegel B, Vellone E. Effectiveness of Motivational Interviewing on contribution to self-care, self-efficacy, and preparedness in caregivers of patients with heart failure: a secondary outcome analysis of the MOTIVATE-HF randomized controlled trial. Eur J Cardiovasc Nurs. 2022 Nov 23;21(8):801-811. doi: 10.1093/eurjcn/zvac013.
citation: Caggianelli G, Iovino P, Rebora P, Occhino G, Zeffiro V, Locatelli G, Ausili D, Alvaro R, Riegel B, Vellone E. A Motivational Interviewing Intervention Improves Physical Symptoms in Patients with Heart Failure: A Secondary Outcome Analysis of the Motivate-HF Randomized Controlled Trial. J Pain Symptom Manage. 2022 Feb;63(2):221-229.e1. doi: 10.1016/j.jpainsymman.2021.09.006. Epub 2021 Sep 25.
citation: Rebora P, Spedale V, Occhino G, Luciani M, Alvaro R, Vellone E, Riegel B, Ausili D. Effectiveness of motivational interviewing on anxiety, depression, sleep quality and quality of life in heart failure patients: secondary analysis of the MOTIVATE-HF randomized controlled trial. Qual Life Res. 2021 Jul;30(7):1939-1949. doi: 10.1007/s11136-021-02788-3. Epub 2021 Feb 22.