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

Primary Purpose

Heart Failure

Status

Completed

Phase

Not Applicable

Locations

Italy

Study Type

Interventional

Intervention

Motivational interviewing

About this trial

This is an interventional supportive care trial for Heart Failure focused on measuring Self-care, Motivational interviewing, Heart failure, Caregivers

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

University of Rome Tor Vergata

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

Arm Label

Motivational interviewing only for patients

Motivational interviewing to patients and caregivers

Control group

Arm Description

In this arm the interventions will be delivered only to patients

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

This Group will receive the usual care

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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).

Patient and Caregiver Anxiety and Depression

Patient and caregiver anxiety and depression will be evaluated with the Hospital Anxiety and Depression Scale

Patient HF Specific Quality of Life

Patient HF specific quality of life will be evaluated with the Kansas City Cardiomyopathy Questionnaire

Patient and Caregiver Quality of Nocturnal Sleep

We will use the Pittsburgh Sleep Quality Index

Patient and Caregiver Mutuality

We will use the Mutuality Scale

Caregiver Preparedness

Caregiver Preparedness will be evaluated with the Caregiver Preparedness Scale

Caregiver Perceived Social Support

We will use the Multidimensional Scale of Perceived Social Support Scale

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.

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.

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.

Full Information

NCT ID

NCT02894502

First Posted

August 26, 2016

Last Updated

February 24, 2021

Sponsor

University of Rome Tor Vergata

Collaborators

Center of Excellence for Nursing Scholarship, Rome, Italy

1. Study Identification

Unique Protocol Identification Number

NCT02894502

Brief Title

MOTIVATional intErviewing to Improve Self-care in Heart Failure Patients

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2021

Overall Recruitment Status

Completed

Study Start Date

June 2014 (undefined)

Primary Completion Date

October 2018 (Actual)

Study Completion Date

October 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Rome Tor Vergata

Collaborators

Center of Excellence for Nursing Scholarship, Rome, Italy

4. Oversight

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Heart Failure

Keywords

Self-care, Motivational interviewing, Heart failure, Caregivers

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

510 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Motivational interviewing only for patients

Arm Type

Experimental

Arm Description

In this arm the interventions will be delivered only to patients

Arm Title

Motivational interviewing to patients and caregivers

Arm Type

Experimental

Arm Description

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

Arm Title

Control group

Arm Type

No Intervention

Arm Description

This Group will receive the usual care

Intervention Type

Behavioral

Intervention Name(s)

Motivational interviewing

Intervention Description

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.

Primary Outcome Measure Information:

Title

Self-care Maintenance in Patients

Description

Time Frame

3 months from the intervention

Secondary Outcome Measure Information:

Title

Burden of HF Symptoms in Patients

Description

Time Frame