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

• ClinicalTrials.gov Identifier: NCT02894502
• Recruitment Status: Completed
• First Posted: September 9, 2016
• Results First Posted: February 24, 2021
• Last Update Posted: March 17, 2021
• Sponsor: University of Rome Tor Vergata
• Collaborator: Center of Excellence for Nursing Scholarship, Rome, Italy
• Information provided by (Responsible Party): Ercole Vellone, University of Rome Tor Vergata

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Heart Failure	Behavioral: Motivational interviewing	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 510 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Supportive Care
• Official Title: MOTIVATional intErviewing to Improve Self-care in Heart Failure Patients (MOTIVATE-HF): Study Protocol of a Three-arm Multicenter Randomized Controlled Trial
• Study Start Date: June 2014
• Actual Primary Completion Date: October 2018
• Actual Study Completion Date: October 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Self-care Maintenance in Patients [ Time Frame: 3 months from the intervention ]
   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.

Secondary Outcome Measures :

1. Burden of HF Symptoms in Patients [ Time Frame: 3, 6, 9 and 12 months from the intervention ]
   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.
2. Patient and Caregiver Generic Physical and Mental Quality of Life [ Time Frame: 3, 6, 9 and 12 months from the intervention ]
   Patient and caregiver generic physical and mental quality of life will be assessed with the Short Form 12 (SF-12).
3. Patient and Caregiver Anxiety and Depression [ Time Frame: 3, 6, 9 and 12 months from the intervention ]
   Patient and caregiver anxiety and depression will be evaluated with the Hospital Anxiety and Depression Scale
4. Patient HF Specific Quality of Life [ Time Frame: 3, 6, 9 and 12 months from the intervention ]
   Patient HF specific quality of life will be evaluated with the Kansas City Cardiomyopathy Questionnaire
5. Patient and Caregiver Quality of Nocturnal Sleep [ Time Frame: 3, 6, 9 and 12 months from the intervention ]
   We will use the Pittsburgh Sleep Quality Index
6. Patient and Caregiver Mutuality [ Time Frame: 3, 6, 9 and 12 months from the intervention ]
   We will use the Mutuality Scale
7. Caregiver Preparedness [ Time Frame: 3, 6, 9 and 12 months from the intervention ]
   Caregiver Preparedness will be evaluated with the Caregiver Preparedness Scale
8. Caregiver Perceived Social Support [ Time Frame: 3, 6, 9 and 12 months from the intervention ]
   We will use the Multidimensional Scale of Perceived Social Support Scale
9. Patient Hospitalizations [ Time Frame: 3, 6, 9 and 12 months from the intervention ]
   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.
10. Use of Emergency Services [ Time Frame: 3, 6, 9 and 12 months from the intervention ]
    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.
11. Death [ Time Frame: 3, 6, 9 and 12 months from the intervention ]
    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.

Eligibility Criteria

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

Criteria

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).

Contacts and Locations

Locations

Italy

University of Rome Tor Vergata

Rome, Italy, 00135

Sponsors and Collaborators

University of Rome Tor Vergata

Center of Excellence for Nursing Scholarship, Rome, Italy

  Study Documents (Full-Text)

Documents provided by Ercole Vellone, University of Rome Tor Vergata:

Study Protocol and Statistical Analysis Plan  [PDF] October 9, 2018

More Information

Publications of Results:

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.

Other 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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Ercole Vellone, Assistant Professor, University of Rome Tor Vergata
• ClinicalTrials.gov Identifier: NCT02894502
• Other Study ID Numbers: 121/13
• First Posted: September 9, 2016
• Results First Posted: February 24, 2021
• Last Update Posted: March 17, 2021
• Last Verified: February 2021

Individual Participant Data (IPD) Sharing Statement:

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

Keywords provided by Ercole Vellone, University of Rome Tor Vergata:

Self-care; Motivational interviewing; Heart failure; Caregivers

Additional relevant MeSH terms:

Heart Failure; Heart Diseases; Cardiovascular Diseases