AzTrials
AzTrials

Heart FailureNCT05595655

Randomized Controlled Trial to Test the Efficacy of Motivational Interviewing on Self-care

A study testing Motivational Interviewing in people with Heart Failure, run by Azienda Socio Sanitaria Territoriale di Lodi at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Introduction: Heart failure (HF) is characterized by an increasing prevalence and burden, representing a public health problem and a major cause of morbidity and mortality. Self-care is a cornerstone approach for optimizing therapy for patients with HF; patients play a key role in the management of their condition… Read more about this study

Who is it for?
Any age
Conditions the study is for
Heart Failure
What is being tested?
Motivational Interviewing
Could I receive a placebo?
No, everyone receives an active treatment
How many people
180 participants
Where
1 siteItaly
Study dates
27 May 2017to 17 May 2021
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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • age ≥ 18 years;
  • diagnosis of HF with New York Heart Association (NYHA) Class II-IV;
  • no acute coronary events within three months;
  • consent to participate in the study;
  • score ≤ 2 to at least two items of the Self-Care of Heart Failure Index 6.2 - SCHFI 6.2 at baseline;
  • score on Six Item Screener > 4;
  • living at home;
  • understanding of spoken and written Italian.

Who cannot join

  • severe cognitive impairment (score 0-4 on the Six-item Screener);
  • acute coronary events that occurred within three months;
  • living in nursing homes or residential settings;
  • caregivers unwilling to participate in the study.

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • Cardiology

    Lodi, Milan, 26903

Other trials in Italy

About this study

Official title: Tailored Intervention for Self-Care Promotion in Patients With Heart Failure: Protocol for a Randomized Controlled Trial to Test the Efficacy of Motivational Interviewing on Self-care

Introduction: Heart failure (HF) is characterized by an increasing prevalence and burden, representing a public health problem and a major cause of morbidity and mortality. Self-care is a cornerstone approach for optimizing therapy for patients with HF; patients play a key role in the management of their condition, given that several negative health outcomes might be avoided with effective self-care. Motivational interviewing (MI) has been described by the literature as highly favorable for treating chronic diseases, with promising results supporting its efficacy in enhancing self-care. Moreover, caregivers' availability constitutes a fundamental supporting factor among the strategies to improve self-care behaviors in people with HF.

Methods and analysis: This study protocol designed a prospective, parallel-arm, open-label, three-arm, controlled trial for purposing the aims to test the efficacy of a structured program including scheduled MI interventions in improving self-care behaviors among patients with HF at 3, 6, 9, and 12 months from the enrolment. Secondary aims comprehend the corroboration of the superiority of caregivers' participation to the structured program including scheduled MI interventions over the program administrated only to individual patients in enhancing self-care behaviors and other outcomes. Analyses will be performed within the framework of intention-to-treat (ITT). Comparisons between groups will be based on an alpha = 5% and two-tailed null hypotheses. In the case of missingness, analyzing the extent of the missingness and identifying underlying mechanisms and patterns will guide imputation methods.

Ethics and dissemination: The study protocol and template consent forms have been reviewed and approved by the Ethical Committee of San Raffaele Hospital (approval #74/INT). Also, the study protocol has been registered at ClinicalTrials.gov (Identifier: …….). Patients and caregivers will have to sign the informed consent forms before the randomisation. Patients and caregivers may leave the study at any time. The withdrawal from the study will not imply any prejudice, as fully documented and explained in the informed consent. Considering the open-access publication, the full protocol will be available freely.

Conditions
Heart Failure
Being tested
Motivational Interviewing
Keywords
heart failure, motivational interviewing, self-care
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 InterviewingBehavioural

    Motivational Interviewing (MI) is a directive client-centred counselling approach for eliciting behavioral change by helping people to explore and resolve ambivalence. MI considers several critical factors to improving self-care in patients with HF and is based on brief interventions, which are feasible in several healthcare settings.

Study groups in NCT05595655
Study groupRoleWhat they receive
control groupNo interventionThe dyads will receive traditional educational treatment only and will complete the questionnaires after 3, 6, 9 and 12 months follow-up post-intervention. Enrolled dyads will be monitored by the research team responsible for recruitment and follow-up.
First interventional armOtherMI intervention will be administered to patients only and caregivers will receive standard education. The intervention will last approximately 30 minutes. Thereafter, the nurse who performed the MI will contact the patients over the phone 3 times during the first 2 months after MI, to strengthen the intervention. Then, the intervention will be employed again after 3, 6, 9 and 12 months from enrolment. After each MI session, both patients and caregivers will be asked to complete the questionnaires of follow-up post-intervention
Receives: Behavioral: Motivational Interviewing
Second interventional armExperimentalMI intervention will be administered both to patients and caregivers. The intervention will be administered to the dyad in one session and patients and their caregivers will receive the reinforcing educational treatment calibrated on the specific lacking areas of patients' self-care behaviours. After each MI session, both patients and caregivers will be asked to complete the questionnaires of follow-up post-intervention.
Receives: Behavioral: Motivational Interviewing

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes will be assessed in the Level of self-care maintenance - Self-Care of Heart Failure Index 6.2

    self-care behavior consisting in keeping the disease stable

    Measured: 3, 6, 9, and 12 months from the enrollment

Secondary outcomes (13)

  1. Changes will be assessed in the Level of caregivers' involvement - Caregiver Contribution to Self-care of Heart Failure Index (CC-SCHFI)

    superiority of the caregivers' participation to the structured program including scheduled MI interventions over the program administrated only to individual patients in enhancing self-care behaviors

    Measured: 3, 6, 9, and 12 months from the enrollment

  2. Changes will be assessed in the Level of patient's ability to feel the symptoms of HF - Heart Failure Somatic Perception Scale (HFSPS)

    patient's ability perceive the symptoms of HF

    Measured: 3, 6, 9, and 12 months from the enrollment

  3. Changes will be assessed in the Level of cognitive impairment- Six Item Screener

    patients' cognitive impairment

    Measured: 3, 6, 9, and 12 months from the enrollment

  4. Changes will be assessed in the Level of physical function, symptoms, social function, self-efficacy, and quality of life (QoL) - Kansas City Cardiomyopathy Questionnaire (KCCQ)

    HF-specific QoL

    Measured: 3, 6, 9, and 12 months from the enrollment

  5. Changes will be assessed in the Level of feeling of intimacy and positive relationship between patient and caregiver -Mutuality Scale (MS)

    feeling of intimacy and positive relationship between patient and caregiver

    Measured: 3, 6, 9, and 12 months from the enrollment

  6. Changes will be assessed in the Level of physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health - SF-12

    generic health-related QoL

    Measured: 3, 6, 9, and 12 months from the enrollment

  7. Changes will be assessed in the Level of presence of significant sleep disturbance experienced in the month before the assessment - Pittsburgh Sleep Quality Index (PSQI)

    sleep quality

    Measured: 3, 6, 9, and 12 months from the enrollment

  8. Changes will be assessed in the Level of depression and anxiety - Hospital Anxiety and Depression Scale (HADS)

    depression and anxiety

    Measured: 3, 6, 9, and 12 months from the enrollment

  9. Changes will be assessed in the Level of cognitive impairment - Montreal Cognitive Assessment (MoCA)

    mild cognitive impairment

    Measured: 3, 6, 9, and 12 months from the enrollment

  10. Changes will be assessed in the Number of comorbidities - Charlson Comorbidity Index (CCI)

    comorbidities

    Measured: 3, 6, 9, and 12 months from the enrollment

  11. Changes will be assessed in the Level of caregiver contribution to self-care - Caregiver Contribution to Self-care of Heart Failure Index (CC-SCHFI)

    caregiver contribution to self-care in patients with HF

    Measured: 3, 6, 9, and 12 months from the enrollment

  12. Changes will be assessed in the Level of caregiver Preparedness - Caregiver Preparedness Scale (CPS)

    Caregiver Preparedness to care

    Measured: 3, 6, 9, and 12 months from the enrollment

  13. Changes will be assessed in the Level of social support - Multidimensional Scale of Perceived Social Support (MSPSS)

    level of social support perceived by HF patients in managing the disease

    Measured: 3, 6, 9, and 12 months from the enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Oct 2022
  2. Study start27 May 2017
  3. Primary completion30 May 2020
  4. Study completion17 May 2021

Resources

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
None (open label)
Enrolment
180 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05595655
Sponsor's protocol ID
Asstlodi-Oct22
Status last verified
Jan 2023
First submitted
20 Oct 2022
Last updated
26 Jan 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: raw data sharing

Publications

  • Dellafiore F, Ghizzardi G, Vellone E, Magon A, Conte G, Baroni I, De Angeli G, Vangone I, Russo S, Arrigoni C, Caruso R. Motivational Interviewing for Enhancing Self-care in Patients With Heart Failure: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2023 Mar 28;12:e44629. doi: 10.2196/44629.

    PubMed 36976630

Questions about this trial

What is this clinical trial studying?

A study testing Motivational Interviewing in people with Heart Failure, run by Azienda Socio Sanitaria Territoriale di Lodi 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 8 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: finished, as of the sponsor's last update on 26 Jan 2023. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes will be assessed in the Level of self-care maintenance - Self-Care of Heart Failure Index 6.2 (time frame: 3, 6, 9, and 12 months from the enrollment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05595655, which also lists 1 linked publication.

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 26 Jan 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in