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

Heart Failure Clinical Trial

— IC-CBC  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04062461
• Other study ID #: 01
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 8, 2019
• Est. completion date: April 30, 2023

Study information

• Verified date: March 2023
• Source: Hospital do Coracao
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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)

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 704
• Est. completion date: April 30, 2023
• Est. primary completion date: January 6, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

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

Locations

Country	Name	City	State
Brazil	Hospital de Clínicas de Porto Alegre	Porto Alegre	Rio Grande Do Sul

Sponsors (2)

Lead Sponsor	Collaborator
Hospital do Coracao	Hospital Moinhos de Vento

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Primary	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	Overall mortality	Overall mortality for Heart Failure at 180 days	Six months
Secondary	Overall hospitalization	Overall hospitalization for Heart Failure at 180 days	Six months
Secondary	Cardiovascular mortality	To evaluate cardiovascular mortality in 180 days	Six months
Secondary	Emergency department visit	To evaluate emergency department visit in 180 days	Six months
Secondary	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
Secondary	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
Secondary	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
Secondary	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.
Secondary	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
Secondary	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.
Secondary	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.