Clinical trial NCT05205018: Remote Motivational Interviewing to Improve Self-care in Heart Failure Patients
Official title: Remote Motivational Interviewing to Improve Self-care in Heart Failure Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Heart Failure
Keywords: heart failure
motivational interviewing
self-care
self-management
behavior change
Video calls
Lead sponsor: University of Rome Tor Vergata
Sponsor class: OTHER
First posted: 2022-01-24
Enrollment: 432
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 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

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. a diagnosis of HF according to international guidelines;
2. Class II, III or IV in the New York Heart Association (NYHA) functional;
3. poor self-care, defined as at least two items of the Self-Care Heart Failure Index 7.2 (SCHFI 7.2) with a score of 0, 1 or 2;
4. age ≥ 18 years;
5. having an internet access to allow the videocalls;
6. willingness to sign the informed consent form. -

Exclusion Criteria:

1. severe cognitive dysfunction, with a score 0 - 4 on the Six-item screener;
2. acute coronary events event in the prior three months;
3. living in nursing homes a residential settings where self-care cannot be performed;
4. if the patient's informal caregiver is not willing to participate in the study.

Primary outcomes:
measure: Self-care maintenance
timeFrame: 3 months from enrollment
Secondary outcomes:
measure: Self-care maintenance
timeFrame: 6, 9 and 12 months from enrollment
measure: Self-care monitoring
timeFrame: 3, 6, 9 and 12 months from enrollment
measure: Self-care management
timeFrame: 3, 6, 9 and 12 months from enrollment
measure: Self-Care Self-Efficacy levels
timeFrame: 3, 6, 9 and 12 months from enrollment
measure: Burden of heart failure physical symptoms
timeFrame: 3, 6, 9 and 12 months from enrollment
measure: Disease specific quality of life
timeFrame: 3, 6, 9 and 12 months from enrollment
measure: Caregiver contribution to heart failure self-care
timeFrame: 3, 6, 9 and 12 months from enrollment
measure: Caregiver preparedness
timeFrame: 3, 6, 9 and 12 months from enrollment
measure: Caregiver burden
timeFrame: 3, 6, 9 and 12 months from enrollment
measure: Health care service uses
timeFrame: 3, 6, 9 and 12 months from enrollment
measure: Patient and caregiver generic quality of life
timeFrame: 3, 6, 9 and 12 months from enrollment
measure: Patient and caregiver anxiety and depression
timeFrame: 3, 6, 9 and 12 months from enrollment
measure: Naturalistic decision making of patients and caregivers
timeFrame: 3, 6, 9 and 12 months from enrollment
Other outcomes:
Locations:
city: Alessandria
country: Italy
facility: Hospital of Alessandria
Study officials:
affiliation: University of Rome Tor Vergata
name: Ercole Vellone, PhD
role: PRINCIPAL_INVESTIGATOR
References: