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Evaluate the Effectiveness of Self-care Multifaceted Strategy in Heart Failure Patients (IC-CBC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04062461
Recruitment Status : Recruiting
First Posted : August 20, 2019
Last Update Posted : August 28, 2019
Sponsor:
Collaborator:
Hospital Moinhos de Vento
Information provided by (Responsible Party):
Hospital do Coracao

Tracking Information
First Submitted Date  ICMJE June 13, 2019
First Posted Date  ICMJE August 20, 2019
Last Update Posted Date August 28, 2019
Actual Study Start Date  ICMJE July 8, 2019
Estimated Primary Completion Date December 20, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 19, 2019)
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. [ Time Frame: six months ]
Variation of NT-proBNP in 180 days;
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT04062461 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 26, 2019)
  • Overall mortality [ Time Frame: Six months ]
    Overall mortality for Heart Failure at 180 days
  • Overall hospitalization [ Time Frame: Six months ]
    Overall hospitalization for Heart Failure at 180 days
  • Cardiovascular mortality [ Time Frame: Six months ]
    To evaluate cardiovascular mortality in 180 days
  • Emergency department visit [ Time Frame: Six months ]
    To evaluate emergency department visit in 180 days
  • Satisfaction of the patient and / or caregiver with health care [ Time Frame: Thirty days ]
    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.
  • Acceptability / adherence to the system of sending messages [ Time Frame: Six months ]
    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.
  • Variation of NT-proBNP in 30 days [ Time Frame: 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.
  • Kansas Health-related quality of life in baseline, 30 and 180 days [ Time Frame: From 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.
  • Variation scale numeric of VAS (Visual Analogue Scale) of dyspnea. [ Time Frame: Baseline, 30, 90 and 180 days visits ]
    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.
  • European Heart Failure Self-Care Behavior Scale - EHFScBs [ Time Frame: From 30 and 180 days. ]
    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.
  • Heart Failure Knowledge Questionnaire [ Time Frame: From 30 and 180 days. ]
    Used to measure Knowledge about Heart Failure. Are by 14 questions more than 70% of correct answers means good Knowledge.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 19, 2019)
  • Overall mortality [ Time Frame: Six months ]
    Overall mortality for Heart Failure at 180 days
  • Overall hospitalization [ Time Frame: Six months ]
    Overall hospitalization for Heart Failure at 180 days
  • Cardiovascular mortality [ Time Frame: Six months ]
    To evaluate cardiovascular mortality in 180 days
  • Emergency department visit [ Time Frame: Six months ]
    To evaluate emergency department visit in 180 days
  • Satisfaction of the patient and / or caregiver with health care [ Time Frame: Thirty days ]
    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.
  • Acceptability / adherence to the system of sending messages [ Time Frame: Six months ]
    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.
  • Variation of NT-proBNP in 30 days [ Time Frame: 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.
  • Kansas Health-related quality of life in baseline, 30 and 180 days [ Time Frame: From 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.
  • Variation scale numeric of VAS (Visual Analogue Scale) of dyspnea. [ Time Frame: Baseline, 30, 90 and 180 days visits ]
    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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluate the Effectiveness of Self-care Multifaceted Strategy in Heart Failure Patients
Official Title  ICMJE A Multicenter Randomized Clinical Trial Aimed at Evaluating the Effectiveness of Self-care Promotion in Patients With Heart Failure
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)
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: Single (Outcomes Assessor)
Masking Description:

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

Primary Purpose: Supportive Care
Condition  ICMJE Heart Failure
Intervention  ICMJE
  • 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.

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

    Intervention: Other: Multifaceted strategy based on sending text messages(SMS)
  • Active Comparator: 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)
    Intervention: Other: Usual outpatient care
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 19, 2019)
700
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 30, 2022
Estimated Primary Completion Date December 20, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Félix J Alvarez Ramires, MD,PhD +55 11 99936-2970 felix.ramires@incor.usp.br
Contact: Alexandre B Cavalcanti, MD,PhD +55 11 99882-9343 abiasi@hcor.com.br
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04062461
Other Study ID Numbers  ICMJE 01
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Hospital do Coracao
Study Sponsor  ICMJE Hospital do Coracao
Collaborators  ICMJE Hospital Moinhos de Vento
Investigators  ICMJE
Principal Investigator: Félix J Alvarez Ramires, Alvarez Ramires Hospital do Coração - HCor
Principal Investigator: Luiz E Rohde, MD,PhD Hospital Moinhos de Vento
PRS Account Hospital do Coracao
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP