MOTIVATional intErviewing to Improve Self-care in Heart Failure Patients (MOTIVATE-HF)

MOTIVATional intErviewing to Improve Self-care in Heart Failure Patients (MOTIVATE-HF): Study Protocol of a Three-arm Multicenter Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Heart Failure
• Intervention / Treatment: Behavioral: Motivational interviewing

• Study Type: Interventional
• Enrollment (Actual): 510
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Rome, Italy, 00135
    • University of Rome Tor Vergata

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion criteria:

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).

Exclusion criteria:

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Motivational interviewing only for patients; In this arm the interventions will be delivered only to patients	Behavioral: Motivational interviewing; 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.
Experimental: Motivational interviewing to patients and caregivers; In this arm the interventions will be delivered both to patients and caregivers	Behavioral: Motivational interviewing; 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.
No Intervention: Control group; This Group will receive the usual care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Burden of HF Symptoms in Patients	Burden of HF symptoms will be measured with the Heart Failure Somatic Perception Scale (HFSPS). The HFSPS has a range score between 0 and 90; the higher the score, the higher the burden of symptoms caused by heart failure.	3, 6, 9 and 12 months from the intervention
Patient and Caregiver Generic Physical and Mental Quality of Life	Patient and caregiver generic physical and mental quality of life will be assessed with the Short Form 12 (SF-12).	3, 6, 9 and 12 months from the intervention
Patient and Caregiver Anxiety and Depression	Patient and caregiver anxiety and depression will be evaluated with the Hospital Anxiety and Depression Scale	3, 6, 9 and 12 months from the intervention
Patient HF Specific Quality of Life	Patient HF specific quality of life will be evaluated with the Kansas City Cardiomyopathy Questionnaire	3, 6, 9 and 12 months from the intervention
Patient and Caregiver Quality of Nocturnal Sleep	We will use the Pittsburgh Sleep Quality Index	3, 6, 9 and 12 months from the intervention
Patient and Caregiver Mutuality	We will use the Mutuality Scale	3, 6, 9 and 12 months from the intervention
Caregiver Preparedness	Caregiver Preparedness will be evaluated with the Caregiver Preparedness Scale	3, 6, 9 and 12 months from the intervention
Caregiver Perceived Social Support	We will use the Multidimensional Scale of Perceived Social Support Scale	3, 6, 9 and 12 months from the intervention
Patient Hospitalizations	The number of patient hospitalizations will be measured asking the caregiver how many time the patient was hospitalized from at 3, 6, 9 and 12 months from the intervention.	3, 6, 9 and 12 months from the intervention
Use of Emergency Services	How many times the patient has used the emergency services will be evaluated by asking the caregiver how many time the patient used after 3, 6, 9 and 12 months from the intervention.	3, 6, 9 and 12 months from the intervention
Death	Death rates will be evaluated in the three arms of the study by caregiver interview at 3, 6, 9 and 12 months from the intervention.	3, 6, 9 and 12 months from the intervention

Collaborators and Investigators

• Sponsor: University of Rome Tor Vergata
• Collaborators: Center of Excellence for Nursing Scholarship, Rome, Italy

Publications and helpful links

General Publications

• 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.
• 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.
• 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. 2022 May 31. doi: 10.1097/JCN.0000000000000929. Online ahead of print.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Actual): October 1, 2018
• Study Completion (Actual): October 1, 2018

Study Registration Dates

• First Submitted: August 26, 2016
• First Submitted That Met QC Criteria: September 3, 2016
• First Posted (Estimate): September 9, 2016

Study Record Updates

• Last Update Posted (Actual): March 17, 2021
• Last Update Submitted That Met QC Criteria: February 24, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Motivational interviewing; Heart failure; Caregivers; Self-care
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: 121/13

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: In case there will be the possibility to share the data, this will be done after data de-identification