Evaluate the Effectiveness of Self-care Multifaceted Strategy in Heart Failure Patients

NCT04062461 | Unknown

• 1 other identifier: 01
• Study Type: interventional
• Target: 704
• Locations: 1 country
• Sites: 1

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

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Overall mortality

  Six months

• Overall hospitalization

  Six months

• Cardiovascular mortality

  Six months

• Emergency department visit

  Six months

• Satisfaction of the patient and / or caregiver with health care

  Thirty days

Other Outcomes (3)

• Win Ratio Analysis

  6 months

• Subgroup Analysis

  Variables at baseline and primary outcome at 6 months

• Analysis according to renal function

  Renal function at baseline and study endpoints at 6 months

Study Arms (2)

self-care promotion

EXPERIMENTAL

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)

Control group

ACTIVE COMPARATOR

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

Interventions

Multifaceted strategy based on sending text messages(SMS) OTHER

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.

self-care promotion

Usual outpatient care OTHER

Educational content on heart failure for the patient (symptoms of the disease, healthy habits for HF, warning signs for severity)

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital do Coracao: lead
• Hospital Moinhos de Vento: collaborator

Study Sites (1)

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Location

Related Publications (2)

• Rohde LE, Rover MM, Hoffmann Filho CR, Rabelo-Silva ER, Silvestre OM, Martins SM, Passos LCS, de Figueiredo Neto JA, Danzmann LC, Silveira FS, Mesas CE, Hernandes ME, Moura LZ, Simoes MV, Ritt LEF, Nishijuka FA, Bertoldi EG, Dall Orto FTC, Magedanz EH, Mourilhe-Rocha R, Fernandes-Silva MM, Ferraz AS, Schwartzmann P, de Castilho FM, Pereira Barretto AC, Dos Santos Junior EG, Nogueira PR, Canesin M, Beck-da-Silva L, de Carvalho Silva M, Adolfi Junior MS, Santos RHN, Ferreira A, Pereira D, Lopez Pedraza L, Kojima FCS, Campos V, de Barros E Silva PGM, Blacher M, Cavalcanti AB, Ramires F; MESSAGE-HF Investigators. Multifaceted Strategy Based on Automated Text Messaging After a Recent Heart Failure Admission: The MESSAGE-HF Randomized Clinical Trial. JAMA Cardiol. 2024 Feb 1;9(2):105-113. doi: 10.1001/jamacardio.2023.4501.

  PMID: 38055237 DERIVED

• 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.

  PMID: 34535979 DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Félix J Alvarez Ramires, Alvarez Ramires

  Hospital do Coração - HCor

  PRINCIPAL INVESTIGATOR

• Luiz E Rohde, MD,PhD

  Hospital Moinhos de Vento

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 13, 2019
• First Posted: August 20, 2019
• Study Start: July 8, 2019
• Primary Completion: January 6, 2023
• Study Completion: April 30, 2023
• Last Updated: March 2, 2023

Record last verified: 2023-03

Locations

BR (1)