MOTIVATional intErviewing to Improve Self-care in Heart Failure Patients

NCT02894502 | Completed Results DMC

• 1 other identifier: 121/13
• Study Type: interventional
• Target: 510
• Locations: 1 country
• Sites: 1

Brief Summary

The aims of this study will be to evaluate the effect of motivational interviewing (MI) to improve self-care in heart failure (HF) patients and caregiver contributions to HF self-care. Also this study will evaluate the effect of MI on the following secondary outcomes: In HF patients: HF somatic symptom perception, generic and specific quality of life, anxiety and depression, sleep quality, mutuality with caregiver, hospitalizations, use of emergency services, and mortality; In caregivers: generic quality of life, anxiety and depression, mutuality with patient, preparedness, social support and sleep quality.

Conditions

Heart Failure

Keywords

Self-care; Motivational interviewing; Heart failure; Caregivers

Outcome Measures

Primary Outcomes (1)

• Self-care Maintenance in Patients

  Self-care in HF patients will be measured with the Self-Care of HF Index V.6.2. Since this instrument has three separate scales, we considered as a primary outcome the score of the Self-care Maintenance scale. The Self-Care Maintenance scale has a score between 0 and 100 with higher score meaning better self-care. Self-Care Maintenance is considered adequate when the score is at least 70.

  3 months from the intervention

Secondary Outcomes (11)

• Burden of HF Symptoms in Patients

  3, 6, 9 and 12 months from the intervention

• Patient and Caregiver Generic Physical and Mental Quality of Life

  3, 6, 9 and 12 months from the intervention

• Patient and Caregiver Anxiety and Depression

  3, 6, 9 and 12 months from the intervention

• Patient HF Specific Quality of Life

  3, 6, 9 and 12 months from the intervention

• Patient and Caregiver Quality of Nocturnal Sleep

  3, 6, 9 and 12 months from the intervention

Study Arms (3)

Motivational interviewing only for patients

EXPERIMENTAL

In this arm the interventions will be delivered only to patients

Behavioral: Motivational interviewing

Motivational interviewing to patients and caregivers

EXPERIMENTAL

In this arm the interventions will be delivered both to patients and caregivers

Behavioral: Motivational interviewing

Control group

NO INTERVENTION

This Group will receive the usual care

Interventions

Motivational interviewing BEHAVIORAL

The intervention will consist of a brief session of motivational interviewing (MI) performed by a trained nurse. During MI, the interventionist will address one or two aspects of self-care that the participants want to address. After this first intervention, the same interventionist will contact the participant by telephone to improve the first intervention and provide further support as needed. These telephone contact will be done three times at two week intervals following the first intervention (for a total of two months). Patients and caregivers that receive the intervention also will be given informational material on HF management that is consistent with international guidelines.

Motivational interviewing only for patients; Motivational interviewing to patients and caregivers

Eligibility Criteria

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

You may qualify if:

• Diagnosis of HF (for patient), New York Heart Association (NYHA) functional class II- IV (for patient), Inadequate self-care assessed with the Self-Care Heart Failure Index (for patient), Being the informal caregiver of the patients (for caregiver).

You may not qualify if:

• Severe cognitive impairment evaluated with the Six-item screener (for patient), Acute coronary syndrome during the last three months (for patient), Living in a residential settings (e.g., nursing home) (for patient), Patients not willing to participate in the study (for caregiver).

Sponsors & Collaborators

• University of Rome Tor Vergata: lead
• Center of Excellence for Nursing Scholarship: collaborator

Study Sites (1)

University of Rome Tor Vergata

Rome, 00135, Italy

Location

Related Publications (11)

• Vellone E, Paturzo M, D'Agostino F, Petruzzo A, Masci S, Ausili D, Rebora P, Alvaro R, Riegel B. MOTIVATional intErviewing to improve self-care in Heart Failure patients (MOTIVATE-HF): Study protocol of a three-arm multicenter randomized controlled trial. Contemp Clin Trials. 2017 Apr;55:34-38. doi: 10.1016/j.cct.2017.02.003. Epub 2017 Feb 7.

  PMID: 28185994 BACKGROUND

• Vellone E, Rebora P, Ausili D, Zeffiro V, Pucciarelli G, Caggianelli G, Masci S, Alvaro R, Riegel B. Motivational interviewing to improve self-care in heart failure patients (MOTIVATE-HF): a randomized controlled trial. ESC Heart Fail. 2020 Jun;7(3):1309-1318. doi: 10.1002/ehf2.12733. Epub 2020 Apr 28.

  PMID: 32343483 RESULT

• Iovino P, Dollaku H, Alvaro R, Pucciarelli G, Rasero L, Macchi C, Liuzzi P, Riegel B, Vellone E. Sleep quality patterns in patients with heart failure: a person-centred latent class analysis from a secondary analysis of the MOTIVATE-HF trial. BMJ Open. 2025 Aug 8;15(8):e101950. doi: 10.1136/bmjopen-2025-101950.

  PMID: 40780724 DERIVED

• Iovino P, Dollaku H, Rasero L, Uchmanowicz I, Alvaro R, Pucciarelli G, Vellone E. Psychometric Testing of the Kansas City Cardiomyopathy Questionnaire 12 in A European Population. J Cardiovasc Nurs. 2025 Feb 27;40(6):E374-82. doi: 10.1097/JCN.0000000000001187. Online ahead of print.

  PMID: 40013908 DERIVED

• Caggianelli G, Alivernini F, Chirico A, Iovino P, Lucidi F, Uchmanowicz I, Rasero L, Alvaro R, Vellone E. The relationship between caregiver contribution to self-care and patient quality of life in heart failure: A longitudinal mediation analysis. PLoS One. 2024 Mar 12;19(3):e0300101. doi: 10.1371/journal.pone.0300101. eCollection 2024.

  PMID: 38470867 DERIVED

• Locatelli G, Iovino P, Jurgens CY, Alvaro R, Uchmanowicz I, Rasero L, Riegel B, Vellone E. The Influence of Caregiver Contribution to Self-care on Symptom Burden in Patients With Heart Failure and the Mediating Role of Patient Self-care: A Longitudinal Mediation Analysis. J Cardiovasc Nurs. 2024 May-Jun 01;39(3):255-265. doi: 10.1097/JCN.0000000000001024. Epub 2023 Aug 8.

  PMID: 37550831 DERIVED

• Locatelli G, Rebora P, Occhino G, Ausili D, Riegel B, Cammarano A, Uchmanowicz I, Alvaro R, Vellone E, Zeffiro V. The Impact of an Intervention to Improve Caregiver Contribution to Heart Failure Self-care on Caregiver Anxiety, Depression, Quality of Life, and Sleep. J Cardiovasc Nurs. 2023 May 18;38(4):361-9. doi: 10.1097/JCN.0000000000000998. Online ahead of print.

  PMID: 37204336 DERIVED

• Spedale V, Fabrizi D, Rebora P, Luciani M, Alvaro R, Vellone E, Riegel B, Ausili D. The Association Between Self-reported Sleep Quality and Self-care in Adults With Heart Failure: A Cross-sectional Study. J Cardiovasc Nurs. 2023 May-Jun 01;38(3):E98-E109. doi: 10.1097/JCN.0000000000000929. Epub 2022 May 31.

  PMID: 37027137 DERIVED

• Locatelli G, Zeffiro V, Occhino G, Rebora P, Caggianelli G, Ausili D, Alvaro R, Riegel B, Vellone E. Effectiveness of Motivational Interviewing on contribution to self-care, self-efficacy, and preparedness in caregivers of patients with heart failure: a secondary outcome analysis of the MOTIVATE-HF randomized controlled trial. Eur J Cardiovasc Nurs. 2022 Nov 23;21(8):801-811. doi: 10.1093/eurjcn/zvac013.

  PMID: 35290454 DERIVED

• Caggianelli G, Iovino P, Rebora P, Occhino G, Zeffiro V, Locatelli G, Ausili D, Alvaro R, Riegel B, Vellone E. A Motivational Interviewing Intervention Improves Physical Symptoms in Patients with Heart Failure: A Secondary Outcome Analysis of the Motivate-HF Randomized Controlled Trial. J Pain Symptom Manage. 2022 Feb;63(2):221-229.e1. doi: 10.1016/j.jpainsymman.2021.09.006. Epub 2021 Sep 25.

  PMID: 34571194 DERIVED

• Rebora P, Spedale V, Occhino G, Luciani M, Alvaro R, Vellone E, Riegel B, Ausili D. Effectiveness of motivational interviewing on anxiety, depression, sleep quality and quality of life in heart failure patients: secondary analysis of the MOTIVATE-HF randomized controlled trial. Qual Life Res. 2021 Jul;30(7):1939-1949. doi: 10.1007/s11136-021-02788-3. Epub 2021 Feb 22.

  PMID: 33616815 DERIVED

MeSH Terms

Conditions

Heart Failure

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Directive Counseling; Counseling; Mental Health Services; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services

Results Point of Contact

• Title: Dr. Ercole Vellone
• Organization: University of Rome Tor vergata, Rome, Italy

ercole.vellone@uniroma2.it

+393387491811

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: August 26, 2016
• First Posted: September 9, 2016
• Study Start: June 1, 2014
• Primary Completion: October 1, 2018
• Study Completion: October 1, 2018
• Last Updated: March 17, 2021
• Results First Posted: February 24, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will share

Locations

IT (1)