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

NCT05205018 | Unknown

• 1 other identifier: 263/21
• Study Type: interventional
• Target: 432
• Locations: 1 country
• Sites: 1

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

Conditions

Heart Failure

Keywords

heart failure; motivational interviewing; self-care; self-management; behavior change; Video calls

Outcome Measures

Primary Outcomes (1)

• 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

  3 months from enrollment

Secondary Outcomes (13)

• Self-care maintenance

  6, 9 and 12 months from enrollment

• Self-care monitoring

  3, 6, 9 and 12 months from enrollment

• Self-care management

  3, 6, 9 and 12 months from enrollment

• Self-Care Self-Efficacy levels

  3, 6, 9 and 12 months from enrollment

• Burden of heart failure physical symptoms

  3, 6, 9 and 12 months from enrollment

Study Arms (2)

Motivational Interviewing Arm

EXPERIMENTAL

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

Standard care Arm

NO INTERVENTION

This Arm will receive the standard of care.

Interventions

Motivational interviewing performed remotely through videocalls 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.

Motivational Interviewing Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• a diagnosis of HF according to international guidelines;
• Class II, III or IV in the New York Heart Association (NYHA) functional;
• 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;
• age ≥ 18 years;
• having an internet access to allow the videocalls;
• willingness to sign the informed consent form. -

You may not qualify if:

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

Sponsors & Collaborators

• University of Rome Tor Vergata: lead

Study Sites (1)

Hospital of Alessandria

Alessandria, Italy

RECRUITING

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Ercole Vellone, PhD

  University of Rome Tor Vergata

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ercole Vellone, PhD

CONTACT

+393387491811; ercole.vellone@uniroma2.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 9, 2022
• First Posted: January 24, 2022
• Study Start: October 3, 2022
• Primary Completion: April 30, 2023
• Study Completion: April 30, 2024
• Last Updated: November 8, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)