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

Heart Failure Clinical Trial

— ReMotivateHF  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05205018
• Other study ID #: 263/21
• Status: Recruiting
• Phase: N/A
• Start date: October 3, 2022
• Est. completion date: April 30, 2024

Study information

• Verified date: November 2022
• Source: University of Rome Tor Vergata
• Contact: Ercole Vellone, PhD
• Phone: +393387491811
• Email: ercole.vellone[@]uniroma2.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 432
• Est. completion date: April 30, 2024
• Est. primary completion date: April 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Heart Failure

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
Italy	Hospital of Alessandria	Alessandria

Sponsors (1)

Lead Sponsor	Collaborator
University of Rome Tor Vergata

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	6, 9 and 12 months from enrollment
Secondary	Self-care monitoring	Self-care monitoring will be measured with the Self-Care Monitoring Scale of the Self-Care of Heart Failure Index v.7.2	3, 6, 9 and 12 months from enrollment
Secondary	Self-care management	Self-care monitoring will be measured with the Self-Care Management Scale of the Self-Care of Heart Failure Index v.7.2	3, 6, 9 and 12 months from enrollment
Secondary	Self-Care Self-Efficacy levels	Self-Care Self-Efficacy will be measured with the Self-Care Self-Efficacy Scale; this scale gives a score from 0 to 100 with higher score meaning higher self-care self-efficacy	3, 6, 9 and 12 months from enrollment
Secondary	Burden of heart failure physical symptoms	The burden of heart failure physical symptom will be measured with the Heart Failure Somatic Perception Scale	3, 6, 9 and 12 months from enrollment
Secondary	Disease specific quality of life	The disease-specific quality of life will be measured with the Kansas City Cardiomyopathy Questionnaire	3, 6, 9 and 12 months from enrollment
Secondary	Caregiver contribution to heart failure self-care	Will be evaluated with the Caregiver Contribution to Self-Care of Heart Failure Index 2	3, 6, 9 and 12 months from enrollment
Secondary	Caregiver preparedness	Will be evaluated with the Caregiver Preparedness Scale	3, 6, 9 and 12 months from enrollment
Secondary	Caregiver burden	Will be evaluated with the Caregiver Burden Inventory	3, 6, 9 and 12 months from enrollment
Secondary	Health care service uses	They will be evaluated with a questionnaire developed by the research team. Specifically wi will evaluate patient mortality, hospitalizations and used of emergency services.	3, 6, 9 and 12 months from enrollment
Secondary	Patient and caregiver generic quality of life	Generic quality of live in patients and in caregivers will be evaluated with the SF-12 Survey	3, 6, 9 and 12 months from enrollment
Secondary	Patient and caregiver anxiety and depression	They will ve evaluated with the Hospital Anxiety and Depression Scale	3, 6, 9 and 12 months from enrollment
Secondary	Naturalistic decision making of patients and caregivers	They will be evaluated with the Naturalistic Decision Making Scale (patient and caregiver version)	3, 6, 9 and 12 months from enrollment