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

Tracking Information

• First Submitted Date: August 26, 2016
• First Posted Date: September 9, 2016
• Results First Submitted Date: November 3, 2020
• Results First Posted Date: February 24, 2021
• Last Update Posted Date: March 17, 2021
• Study Start Date: June 2014
• Actual Primary Completion Date: October 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 6, 2021)

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.

Original Primary Outcome Measures (submitted: September 3, 2016)

• Self-care in patients and in caregivers [ 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. Self-care in caregivers will be measured with the Caregiver Contribution to Self-Care of HF Index.
• Self-care changes in patients and in caregivers [ Time Frame: 12 month from the intervention ]
  Self-care in HF patients will be measured with the Self-Care of HF Index V.6.2. Self-care in caregivers will be measured with the Caregiver Contribution to Self-Care of HF Index.

Current Secondary Outcome Measures (submitted: February 6, 2021)

• 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.
• 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).
• 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
• 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
• 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
• Patient and Caregiver Mutuality [ Time Frame: 3, 6, 9 and 12 months from the intervention ]
  We will use the Mutuality Scale
• Caregiver Preparedness [ Time Frame: 3, 6, 9 and 12 months from the intervention ]
  Caregiver Preparedness will be evaluated with the Caregiver Preparedness Scale
• 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
• 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.
• 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.
• 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.

Original Secondary Outcome Measures (submitted: September 3, 2016)

• 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
• 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).
• 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
• 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
• 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
• Patient and caregiver mutuality [ Time Frame: 3, 6, 9 and 12 months from the intervention ]
  We will use the Mutuality Scale
• Caregiver preparedness [ Time Frame: 3, 6, 9 and 12 months from the intervention ]
  Caregiver Preparedness will be evaluated with the Caregiver Preparedness Scale
• 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
• 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.
• 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.
• 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.

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: MOTIVATional intErviewing to Improve Self-care in Heart Failure Patients
• Official Title: MOTIVATional intErviewing to Improve Self-care in Heart Failure Patients (MOTIVATE-HF): Study Protocol of a Three-arm Multicenter Randomized Controlled Trial
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Supportive Care
• Condition: Heart Failure

Intervention

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.

Study Arms

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

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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 6, 2021): 510
• Original Estimated Enrollment (submitted: September 3, 2016): 200
• Actual Study Completion Date: October 2018
• Actual Primary Completion Date: October 2018 (Final data collection date for primary outcome measure)

Eligibility 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).

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Italy

Administrative Information

• NCT Number: NCT02894502
• Other Study ID Numbers: 121/13
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided

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

• Current Responsible Party: Ercole Vellone, University of Rome Tor Vergata
• Original Responsible Party: Same as current
• Current Study Sponsor: University of Rome Tor Vergata
• Original Study Sponsor: Same as current
• Collaborators: Center of Excellence for Nursing Scholarship, Rome, Italy
• Investigators: Not Provided
• PRS Account: University of Rome Tor Vergata
• Verification Date: February 2021