MOTIVATional intErviewing to Improve Self-care in Heart Failure Patients

Heart Failure Clinical Trial

— MOTIVATE-HF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02894502
• Other study ID #: 121/13
• Status: Completed
• Phase: N/A
• Start date: June 2014
• Est. completion date: October 2018

Study information

• Verified date: February 2021
• Source: University of Rome Tor Vergata
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 510
• Est. completion date: October 2018
• Est. primary completion date: October 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• 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.

Locations

Country	Name	City	State
Italy	University of Rome Tor Vergata	Rome

Sponsors (2)

Lead Sponsor	Collaborator
University of Rome Tor Vergata	Center of Excellence for Nursing Scholarship, Rome, Italy

Country where clinical trial is conducted

Italy, 

References & Publications (2)

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. — View Citation

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- — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Patient and Caregiver Quality of Nocturnal Sleep	We will use the Pittsburgh Sleep Quality Index	3, 6, 9 and 12 months from the intervention
Secondary	Patient and Caregiver Mutuality	We will use the Mutuality Scale	3, 6, 9 and 12 months from the intervention
Secondary	Caregiver Preparedness	Caregiver Preparedness will be evaluated with the Caregiver Preparedness Scale	3, 6, 9 and 12 months from the intervention
Secondary	Caregiver Perceived Social Support	We will use the Multidimensional Scale of Perceived Social Support Scale	3, 6, 9 and 12 months from the intervention
Secondary	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
Secondary	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
Secondary	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