Clinical trial NCT04062461: Evaluate the Effectiveness of Self-care Multifaceted Strategy in Heart Failure Patients
Official title: A Multicenter Randomized Clinical Trial Aimed at Evaluating the Effectiveness of Self-care Promotion in Patients With Heart Failure
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Heart Failure
Lead sponsor: Hospital do Coracao
Sponsor class: OTHER
Collaborators: name: Hospital Moinhos de Vento
First posted: 2019-08-20
Enrollment: 704
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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

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)

Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: six months
Secondary outcomes:
measure: Overall mortality
timeFrame: Six months
measure: Overall hospitalization
timeFrame: Six months
measure: Cardiovascular mortality
timeFrame: Six months
measure: Emergency department visit
timeFrame: Six months
measure: Satisfaction of the patient and / or caregiver with health care
timeFrame: Thirty days
measure: Acceptability / adherence to the system of sending messages
timeFrame: Six months
measure: Variation of NT-proBNP in 30 days
timeFrame: 30 days
measure: Kansas Health-related quality of life in baseline, 30 and 180 days
timeFrame: From baseline, 30 and 180 days.
measure: Variation scale numeric of VAS (Visual Analogue Scale) of dyspnea.
timeFrame: Baseline, 30, 90 and 180 days visits
measure: European Heart Failure Self-Care Behavior Scale - EHFScBs
timeFrame: From 30 and 180 days.
measure: Heart Failure Knowledge Questionnaire
timeFrame: From 30 and 180 days.
Other outcomes:
measure: Win Ratio Analysis
timeFrame: 6 months
measure: Subgroup Analysis
timeFrame: Variables at baseline and primary outcome at 6 months
measure: Analysis according to renal function
timeFrame: Renal function at baseline and study endpoints at 6 months
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital de Clínicas de Porto Alegre
state: Rio Grande Do Sul
Study officials:
affiliation: Hospital do Coração - HCor
name: Félix J Alvarez Ramires, Alvarez Ramires
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Moinhos de Vento
name: Luiz E Rohde, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.