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

NCT ID: NCT04062461

Last Updated: 2023-03-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 704 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-08
• Study Completion Date: 2023-04-30

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)

Conditions

Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Multifaceted strategy based on sending text messages(SMS)

Intervention Type: 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.

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)

Group Type: ACTIVE_COMPARATOR

Usual outpatient care

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: OTHER

Usual outpatient care

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Moinhos de Vento

OTHER

Sponsor Role: collaborator

Hospital do Coracao

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Félix J Alvarez Ramires, Alvarez Ramires

Role: PRINCIPAL_INVESTIGATOR

Hospital do Coração - HCor

Luiz E Rohde, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital Moinhos de Vento

Locations

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Countries

Brazil

References

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.

Reference Type: DERIVED

PMID: 38055237 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 34535979 (View on PubMed)

Other Identifiers

01

Identifier Type: -

Identifier Source: org_study_id