Remote Motivational Interviewing to Improve Self-care in Heart Failure Patients

NCT ID: NCT05205018

Last Updated: 2022-11-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 432 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-03
• Study Completion Date: 2024-04-30

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.

Conditions

Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

Motivational Interviewing Arm

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.

Group Type: EXPERIMENTAL

Motivational interviewing performed remotely through videocalls

Intervention Type: BEHAVIORAL

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.

Standard care Arm

This Arm will receive the standard of care.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Motivational interviewing performed remotely through videocalls

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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Rome Tor Vergata

OTHER

Sponsor Role: lead

Responsible Party

Ercole Vellone

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ercole Vellone, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Rome Tor Vergata

Locations

Hospital of Alessandria

Alessandria, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Ercole Vellone, PhD

Role: CONTACT

ercole.vellone@uniroma2.it

+393387491811

Facility Contacts

Tatiana Bolgeo

Role: primary

Other Identifiers

263/21

Identifier Type: -

Identifier Source: org_study_id