Back to resultsRemote Motivational Interviewing to Improve Self-care in Heart Failure Patients (ReMotivateHF)
Primary Purpose
Heart Failure
Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Motivational interviewing performed remotely through videocalls
Sponsored by
About this trial
This is an interventional supportive care trial for Heart Failure focused on measuring heart failure, motivational interviewing, self-care, self-management, behavior change, Video calls
Eligibility Criteria
Inclusion Criteria:
- 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. -
Exclusion Criteria:
- 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.
Sites / Locations
- Hospital of AlessandriaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Motivational Interviewing Arm
Standard care Arm
Arm Description
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.
This Arm will receive the standard of care.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
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
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
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
Burden of heart failure physical symptoms
The burden of heart failure physical symptom will be measured with the Heart Failure Somatic Perception Scale
Disease specific quality of life
The disease-specific quality of life will be measured with the Kansas City Cardiomyopathy Questionnaire
Caregiver contribution to heart failure self-care
Will be evaluated with the Caregiver Contribution to Self-Care of Heart Failure Index 2
Caregiver preparedness
Will be evaluated with the Caregiver Preparedness Scale
Caregiver burden
Will be evaluated with the Caregiver Burden Inventory
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.
Patient and caregiver generic quality of life
Generic quality of live in patients and in caregivers will be evaluated with the SF-12 Survey
Patient and caregiver anxiety and depression
They will ve evaluated with the Hospital Anxiety and Depression Scale
Naturalistic decision making of patients and caregivers
They will be evaluated with the Naturalistic Decision Making Scale (patient and caregiver version)
Full Information
NCT ID
NCT05205018
First Posted
January 9, 2022
Last Updated
November 2, 2022
Sponsor
University of Rome Tor Vergata
1. Study Identification
Unique Protocol Identification Number
NCT05205018
Brief Title
Remote Motivational Interviewing to Improve Self-care in Heart Failure Patients
Acronym
ReMotivateHF
Official Title
Remote Motivational Interviewing to Improve Self-care in Heart Failure Patients
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 3, 2022 (Actual)
Primary Completion Date
April 30, 2023 (Anticipated)
Study Completion Date
April 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rome Tor Vergata
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
heart failure, motivational interviewing, self-care, self-management, behavior change, Video calls
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
432 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Motivational Interviewing Arm
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard care Arm
Arm Type
No Intervention
Arm Description
This Arm will receive the standard of care.
Intervention Type
Behavioral
Intervention Name(s)
Motivational interviewing performed remotely through videocalls
Intervention Description
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.
Primary Outcome Measure Information:
Title
Self-care maintenance
Description
Self-care maintenance will be measured with the Self-Care Maintenance Scale of the Self-Care of Heart Failure Index v.7.2
Time Frame
3 months from enrollment
Secondary Outcome Measure Information:
Title
Self-care maintenance
Description
Self-care maintenance will be measured with the Self-Care Maintenance Scale of the Self-Care of Heart Failure Index v.7.2
Time Frame
6, 9 and 12 months from enrollment
Title
Self-care monitoring
Description
Self-care monitoring will be measured with the Self-Care Monitoring Scale of the Self-Care of Heart Failure Index v.7.2
Time Frame
3, 6, 9 and 12 months from enrollment
Title
Self-care management
Description
Self-care monitoring will be measured with the Self-Care Management Scale of the Self-Care of Heart Failure Index v.7.2
Time Frame
3, 6, 9 and 12 months from enrollment
Title
Self-Care Self-Efficacy levels
Description
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
Time Frame
3, 6, 9 and 12 months from enrollment
Title
Burden of heart failure physical symptoms
Description
The burden of heart failure physical symptom will be measured with the Heart Failure Somatic Perception Scale
Time Frame
3, 6, 9 and 12 months from enrollment
Title
Disease specific quality of life
Description
The disease-specific quality of life will be measured with the Kansas City Cardiomyopathy Questionnaire
Time Frame
3, 6, 9 and 12 months from enrollment
Title
Caregiver contribution to heart failure self-care
Description
Will be evaluated with the Caregiver Contribution to Self-Care of Heart Failure Index 2
Time Frame
3, 6, 9 and 12 months from enrollment
Title
Caregiver preparedness
Description
Will be evaluated with the Caregiver Preparedness Scale
Time Frame
3, 6, 9 and 12 months from enrollment
Title
Caregiver burden
Description
Will be evaluated with the Caregiver Burden Inventory
Time Frame
3, 6, 9 and 12 months from enrollment
Title
Health care service uses
Description
They will be evaluated with a questionnaire developed by the research team. Specifically wi will evaluate patient mortality, hospitalizations and used of emergency services.
Time Frame
3, 6, 9 and 12 months from enrollment
Title
Patient and caregiver generic quality of life
Description
Generic quality of live in patients and in caregivers will be evaluated with the SF-12 Survey
Time Frame
3, 6, 9 and 12 months from enrollment
Title
Patient and caregiver anxiety and depression
Description
They will ve evaluated with the Hospital Anxiety and Depression Scale
Time Frame
3, 6, 9 and 12 months from enrollment
Title
Naturalistic decision making of patients and caregivers
Description
They will be evaluated with the Naturalistic Decision Making Scale (patient and caregiver version)
Time Frame
3, 6, 9 and 12 months from enrollment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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. -
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ercole Vellone, PhD
Phone
+393387491811
Email
ercole.vellone@uniroma2.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ercole Vellone, PhD
Organizational Affiliation
University of Rome Tor Vergata
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital of Alessandria
City
Alessandria
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tatiana Bolgeo
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Remote Motivational Interviewing to Improve Self-care in Heart Failure Patients
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