Heart FailureReMotivateHFNCT05205018
Remote Motivational Interviewing to Improve Self-care in Heart Failure Patients
A study testing Motivational interviewing performed remotely through videocalls in people with Heart Failure, run by University of Rome Tor Vergata at 1 site in Italy.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Motivational interviewing performed remotely through videocalls
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 432 participants
- Where
- 1 siteItaly
- Study dates
- 3 Oct 2022to 30 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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. -
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Hospital of Alessandria
Alessandria
Tatiana Bolgeo
About this study
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
Read the 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
- Being tested
- Motivational interviewing performed remotely through videocalls
- Keywords
- heart failure, motivational interviewing, self-care, self-management, behavior change, Video calls
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational interviewing performed remotely through videocallsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Motivational interviewing performed remotely through videocalls |
| Standard care Arm | No intervention | This Arm will receive the standard of care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 months from enrollment
Secondary outcomes (13)
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
Measured: 6, 9 and 12 months from enrollment
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
Measured: 3, 6, 9 and 12 months from enrollment
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
Measured: 3, 6, 9 and 12 months from enrollment
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
Measured: 3, 6, 9 and 12 months from enrollment
Burden of heart failure physical symptoms
The burden of heart failure physical symptom will be measured with the Heart Failure Somatic Perception Scale
Measured: 3, 6, 9 and 12 months from enrollment
Disease specific quality of life
The disease-specific quality of life will be measured with the Kansas City Cardiomyopathy Questionnaire
Measured: 3, 6, 9 and 12 months from enrollment
Caregiver contribution to heart failure self-care
Will be evaluated with the Caregiver Contribution to Self-Care of Heart Failure Index 2
Measured: 3, 6, 9 and 12 months from enrollment
Caregiver preparedness
Will be evaluated with the Caregiver Preparedness Scale
Measured: 3, 6, 9 and 12 months from enrollment
Caregiver burden
Will be evaluated with the Caregiver Burden Inventory
Measured: 3, 6, 9 and 12 months from enrollment
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.
Measured: 3, 6, 9 and 12 months from enrollment
Patient and caregiver generic quality of life
Generic quality of live in patients and in caregivers will be evaluated with the SF-12 Survey
Measured: 3, 6, 9 and 12 months from enrollment
Patient and caregiver anxiety and depression
They will ve evaluated with the Hospital Anxiety and Depression Scale
Measured: 3, 6, 9 and 12 months from enrollment
Naturalistic decision making of patients and caregivers
They will be evaluated with the Naturalistic Decision Making Scale (patient and caregiver version)
Measured: 3, 6, 9 and 12 months from enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2022
- Study start3 Oct 2022
- Primary completion30 Apr 2023 (estimated)
- Study completion30 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 432 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Rome Tor Vergata
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ercole Vellone, University of Rome Tor Vergata
- Investigators
- Ercole Vellone, PhD, Principal investigator, University of Rome Tor Vergata
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05205018
- Sponsor's protocol ID
- 263/21
- Acronym
- ReMotivateHF
- Status last verified
- Nov 2022
- First submitted
- 9 Jan 2022
- Last updated
- 8 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Motivational Interviewing to Improve Self-care in Heart Failure Patients
- ClinicalTrials.gov ID
- NCT05205018
- Acronym / sponsor ID
- ReMotivateHF / 263/21
- Conditions
- Heart Failure
- Keywords
- heart failure, motivational interviewing, self-care, self-management, behavior change, Video calls
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 432 participants (estimated)
- Lead sponsor
- University of Rome Tor VergataUniversity, hospital or other
- Study start
- 3 Oct 2022 (actual)
- Primary completion
- 30 Apr 2023 (estimated)
- Study completion
- 30 Apr 2024 (estimated)
- First posted
- 24 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Motivational Interviewing Arm | Experimental | Behavioral: Motivational interviewing performed remotely through videocallsThis 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. |
| Standard care Arm | No intervention | –This Arm will receive the standard of care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motivational interviewing performed remotely through videocallsRemote 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. | Behavioural | Motivational Interviewing Arm |
Primary outcome
Self-care maintenance
Time frame: 3 months from enrollment
Self-care maintenance will be measured with the Self-Care Maintenance Scale of the Self-Care of Heart Failure Index v.7.2
13 secondary outcomes
Self-care maintenance
Time frame: 6, 9 and 12 months from enrollment
Self-care monitoring
Time frame: 3, 6, 9 and 12 months from enrollment
Self-care management
Time frame: 3, 6, 9 and 12 months from enrollment
Self-Care Self-Efficacy levels
Time frame: 3, 6, 9 and 12 months from enrollment
Burden of heart failure physical symptoms
Time frame: 3, 6, 9 and 12 months from enrollment
Disease specific quality of life
Time frame: 3, 6, 9 and 12 months from enrollment
Caregiver contribution to heart failure self-care
Time frame: 3, 6, 9 and 12 months from enrollment
Caregiver preparedness
Time frame: 3, 6, 9 and 12 months from enrollment
Caregiver burden
Time frame: 3, 6, 9 and 12 months from enrollment
Health care service uses
Time frame: 3, 6, 9 and 12 months from enrollment
Patient and caregiver generic quality of life
Time frame: 3, 6, 9 and 12 months from enrollment
Patient and caregiver anxiety and depression
Time frame: 3, 6, 9 and 12 months from enrollment
Naturalistic decision making of patients and caregivers
Time frame: 3, 6, 9 and 12 months from enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ercole Vellone, PhD principal investigator
University of Rome Tor Vergata
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivational interviewing performed remotely through videocalls in people with Heart Failure, run by University of Rome Tor Vergata at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ercole Vellone, PhD (+393387491811, ercole.vellone@uniroma2.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-care maintenance (time frame: 3 months from enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2022.