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| Name | Class |
|---|---|
| Hospital Moinhos de Vento | OTHER |
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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:
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:
Control group:
-Usual outpatient care
Follow-up
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Félix J Alvarez Ramires, Alvarez Ramires | Hospital do Coração - HCor | Principal Investigator |
| Luiz E Rohde, MD,PhD | Hospital Moinhos de Vento | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de ClÃnicas de Porto Alegre | Porto Alegre | Rio Grande do Sul | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38055237 | Derived | 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. | |
| 34535979 |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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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.
Not provided
Not provided
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:
Control group:
-Usual outpatient care
|
| Usual outpatient care | Other | Educational content on heart failure for the patient (symptoms of the disease, healthy habits for HF, warning signs for severity) |
|
| 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. |
| 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 |
| 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. |