Evaluate the Effectiveness of Self-care Multifaceted Strategy in Heart Failure Patients (IC-CBC)

A Multicenter Randomized Clinical Trial Aimed at Evaluating the Effectiveness of Self-care Promotion in Patients With Heart Failure

Study Design: A randomized, multicenter, national, phase II clinical trial aimed at evaluating the effectiveness of self-care promotion using a multifaceted strategy based on sending text messages(SMS)to patients with heart failure.

Methodological quality:

• Central randomization with allocation concealment;
• Decision committee for blind outcome assessment;
• Intention-to-treat analysis

Study Overview

• Status: Active, not recruiting
• Conditions: Heart Failure
• Intervention / Treatment: Other: Multifaceted strategy based on sending text messages(SMS); Other: Usual outpatient care

Detailed Description

Study Design -A randomized, multicenter, national, phase II clinical trial aimed at evaluating the effectiveness of self-care promotion using a multifaceted strategy based on sending text messages(SMS) to patients with heart failure.

Methodological quality

-Central randomization with allocation concealment; Decision committee for blind outcome assessment; Intention-to-treat analysis

Primary Objective -To develop and evaluate the feasibility of a monitoring, education and self-care strategy to optimize the management of patients with heart failure (HF) after hospital discharge.

Secondary Objectives

-To evaluate, in patients with heart failure, the effect of a self-care promotion program using a multifaceted strategy in comparison to the usual care about acceptability to the application of SMS, patient and / or family satisfaction with care, quality of life scales health scales, self-care scales and knowledge on HF, visual analog scale of dyspnea, and clinical outcomes at 30 and 180 days.

Experimental group:

-Self-care promotion using a multifaceted strategy based on the use of a tele-monitoring device, based on short message system (SMS) messages and self-care teaching tools.

Patients will receive daily messages to optimize self-care in heart failure with the following functions:

• customized reminders about medication schedules
• weight and symptoms of decompensation monitoring assessing a decision tree with diuretics adjustment if needed and alerts that define the need to contact a health professional for early intervention before deterioration of the clinical state, identifying situations that require clinical intervention.
• educational content on heart failure for the patient (symptoms of the disease, healthy habits for HF, warning signs for severity)
• diary for registration of visits to health services and clinical setting.

Control group:

-Usual outpatient care

Follow-up

• Follow up will be at least 180 days from the inclusion in the study.
• Sample size estimation 350 patients per group (700 patients)

• Study Type: Interventional
• Enrollment (Actual): 704
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Félix J Alvarez Ramires, MD,PhD; Phone Number: +55 11 99936-2970; Email: felix.ramires@incor.usp.br
• Study Contact Backup: Name: Alexandre B Cavalcanti, MD,PhD; Phone Number: +55 11 99882-9343; Email: abiasi@hcor.com.br

Study Locations

• Brazil
  • Rio Grande Do Sul
    • Porto Alegre, Rio Grande Do Sul, Brazil
      • Hospital de Clinicas de Porto Alegre

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:

• Adults (> 18 years)
• Heart failure of any etiology
• Vulnerable period after episode of acute decompensation
• Cellular telephony acess;
• Left Ventricular Ejection Fraction (LVEF <40%),

Exclusion Criteria:

• Cardiac transplant wait list;
• Surgical or percutaneous (coronary or valvular) treatment at last 3 months
• HF terminal ;
• Life expectancy <1 year;
• Another drug or device study at last 30 days
• Prior randomization in the study

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: self-care promotion; multifaceted strategy based on sending text messages(SMS) to patients with heart failure. Press educational content on heart failure for the patient (symptoms of the disease, healthy habits for HF, warning signs for severity). The text messages are about how the patient should take your drugs (evem diuretics), measure blood pressure and weight in Kg, and about signals and symptoms (shorthbreathness during the night), and about how important is practice physical exercises and don't drink alcohol.	Other: Multifaceted strategy based on sending text messages(SMS); multifaceted strategy based on sending text messages(SMS) to patients with heart failure. Press educational content on heart failure for the patient (symptoms of the disease, healthy habits for HF, warning signs for severity). The text messages are about how the patient should take your drugs (evem diuretics), measure blood pressure and weight in Kg, and about signals and symptoms (shorthbreathness during the night), and about how important is practice physical exercises and don't drink alcohol.
Active Comparator: Control group; routinely management in the HF. Press educational content on heart failure for the patient (symptoms of the disease, healthy habits for HF, warning signs for severity)	Other: Usual outpatient care; Educational content on heart failure for the patient (symptoms of the disease, healthy habits for HF, warning signs for severity)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The evaluation of the effect of multifaceted intervention compared to usual outpatient care on the primary endpoint will be performed using the Student's t-Student test of the log ratio of NT-proBNP levels at 6 months baseline.	Variation of NT-proBNP in 180 days;	six months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall mortality	Overall mortality for Heart Failure at 180 days	Six months
Overall hospitalization	Overall hospitalization for Heart Failure at 180 days	Six months
Cardiovascular mortality	To evaluate cardiovascular mortality in 180 days	Six months
Emergency department visit	To evaluate emergency department visit in 180 days	Six months
Satisfaction of the patient and / or caregiver with health care	Using (NPS tool):Scale of 0-10 to measure satisfaction of the patient and / or caregiver with health care. Rate it from 0 to 10, where 0 means not at all satisfied and 10 means extremely satisfied.	Thirty days
Acceptability / adherence to the system of sending messages	Using a Scale of 0-10 (question to insert the note) to measure acceptability / adherence to the system of sending messages. Rate it from 0 to 10, where 0 means no help at all and 10 means the posts were extremely beneficial.	Six months
Variation of NT-proBNP in 30 days	The evaluation of the effect of multifaceted intervention compared to usual outpatient care on the primary endpoint will be performed using the Student's t-Student test of the log ratio of NT-proBNP levels at 30 days from baseline.	30 days
Kansas Health-related quality of life in baseline, 30 and 180 days	Using (Kansas Health-related quality of life Questionnaire): Scale of 0-100 to measure quality of life in patients with heart failure. Rate it from 0 to 100. Overall score means higher is better.	From baseline, 30 and 180 days.
Variation scale numeric of VAS (Visual Analogue Scale) of dyspnea.	Using Variation scale numeric of VAS (Visual Analogue Scale) to measure degree of dyspnea. Rate from 0 to 10, where 0 means no dyspnea and 10 the highest complain of dyspnea.	Baseline, 30, 90 and 180 days visits
European Heart Failure Self-Care Behavior Scale - EHFScBs	Using (EHFScBs): Scale of 0-60 to to measure self-care behavior of heart failure (HF) patients. Rate it from 0 to 60. Overall score means smaller is better.	From 30 and 180 days.
Heart Failure Knowledge Questionnaire	Used to measure Knowledge about Heart Failure. Are by 14 questions more than 70% of correct answers means good Knowledge.	From 30 and 180 days.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Win Ratio Analysis	A pre-specified analysis using the win ratio method will be performed. A composite outcome will be analysed in the hierarchical order of 1) time to cardiovascular death; 2) time to first hospitalization due to heart failure; 3) relative change in NT-proBNP from baseline to 180 days. In this last comparison, to have a winner, the relative change needs to differ by more than 20% between two subjects. By the protocol, all the clinical outcomes (including CV death and HF hospitalization) will be assessed until 6 months.	6 months
Subgroup Analysis	Analysis of the primary endpoint will be performed in pre-specified subgroups: age strata, gender, educational levels, New York Heart Association functional classes, left ventricular ejection fraction strata, NT-proBNP levels, HF aetiology, baseline KCCQ scores, and baseline HF self-care and knowledge scores.	Variables at baseline and primary outcome at 6 months
Analysis according to renal function	Analysis of study endpoints (cardiovascular mortality, hospitalization due to heart failure and NT-proBNP variation) will be performed according to baseline renal function strata.	Renal function at baseline and study endpoints at 6 months

Collaborators and Investigators

• Sponsor: Hospital do Coracao
• Collaborators: Hospital Moinhos de Vento

Publications and helpful links

General Publications

• Rohde LE, Hoffmann Filho CR, Rover MM, Rabelo-Silva ER, Lopez L, Passos LCS, Silvestre OM, Martins SM, de Figueiredo Neto JA, Silveira FS, Canesin MF, Simoes MV, Akio Nishijuka F, Bertoldi EG, Danzmann LC, Mourilhe-Rocha R, Magedanz EH, Esteves M, de Castilho FM, Fernandes-Silva MM, Ritt LEF, Blacher M, Soares RM, Cavalcanti AB, Ramirez F. Design of a multifaceted strategy based on automated text messaging in patients with recent heart failure admission. ESC Heart Fail. 2021 Dec;8(6):5523-5530. doi: 10.1002/ehf2.13516. Epub 2021 Sep 18.

Study record dates

Study Major Dates

• Study Start (Actual): July 8, 2019
• Primary Completion (Actual): January 6, 2023
• Study Completion (Anticipated): April 30, 2023

Study Registration Dates

• First Submitted: June 13, 2019
• First Submitted That Met QC Criteria: August 19, 2019
• First Posted (Actual): August 20, 2019

Study Record Updates

• Last Update Posted (Actual): March 2, 2023
• Last Update Submitted That Met QC Criteria: March 1, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: 01 (Miami VAHS)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No