Nursing Teleconsultation for Patients With Heart Failure (NurTHF)
Primary Purpose
Heart Failure
Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Nursing teleconsultation for lifestyle changes
Sponsored by
About this trial
This is an interventional supportive care trial for Heart Failure focused on measuring Nurse, Teleconsultation, Heart Failure
Eligibility Criteria
Inclusion Criteria:
- Patients already registered in a database of the Clinical Unit of Cardiomyopathies and Aortic Diseases, InCor - HCFMUSP and Clinical Hypertension Unit - HCFMUSP, in outpatient follow-up for more than a year;
- Stroke Volume < 40% and >25%
Exclusion Criteria:
- Patientes with Pacemaker, Defibrillators, Implantable and Cardiac Resynchronization Therapy
- Listed in heart transplant queue
- Not having technological devices that allow the teleconsultation to be carried out
- Psychic inability to understand the questionnaires and answer the questions asked by the interviewer
Sites / Locations
- Heart Institute (InCor), Hospital das Clinicas do HCFMUSP
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Intervention Group
Control Group
Arm Description
Consultations will be carried out via video call, every 15 days for a period of 3 months, with a total of 6 telephone consultations that will have in order to clarify doubts about the CI, the monitoring of possible clinical signs of instability and help in adapting or creating strategies for better adherence to therapy.
Will be composed by the participants who will have no intervention and will continue to monitor according to the institution's routine.
Outcomes
Primary Outcome Measures
Improvement in the quality of life of patients who receive teleconsultations with a nurse
To analyze this result, the questionnaire Minnesota Living with Heart Failure Questionnaire (MLHFQ) validated in portuguese language will be used. Zero is the minimum value and 105 maximum value, The lower score, represents a better patient's quality of life.
Improvement in the therapeutic adhesion of patients who receive teleconsultations with a nurse
To analyze this result, the questionnaire European Heart Failure Self-Care Behaviour Scale (EHFScBS) validated in portuguese language will be used. 12 is the minimum value and 60 maximum value, The lower score, represents a better self care.
Secondary Outcome Measures
Full Information
NCT ID
NCT05027399
First Posted
July 28, 2021
Last Updated
February 3, 2022
Sponsor
University of Sao Paulo General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05027399
Brief Title
Nursing Teleconsultation for Patients With Heart Failure
Acronym
NurTHF
Official Title
Nursing Teleconsultation for Patients With Heart Failure Due to Hypersensitive, Chagasic or Idiopathic
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 20, 2022 (Anticipated)
Primary Completion Date
November 20, 2022 (Anticipated)
Study Completion Date
November 22, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Sao Paulo General Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The incidence and prevalence of heart failure are increasing and represent a large portion of hospitalizations in Brazil, are also associated with high rates of morbidity, mortality and costs for the service of health. Such data, added to the current scenario of the pandemic caused by COVID-19, reveal the need for changes in clinical practice, so that health care is more effective and cost-effective and reaches patients without exposing them to risks. Thus, the application of nursing interventions through of telephone technology, which has strong evidence of effectiveness found in the literature, has become an alternative for the implementation of clinical interventions. Objective: Evaluate the effectiveness of nursing consultations performed remotely in improving quality of life and adherence to therapy of patients with HF due to cardiomyopathy of different etiologies. Method: The study will have as methodological framework the randomized clinical trial, with the recruitment of 60 volunteers with a diagnosis of chagasic HF, Hypertensive or Idiopathic, who are monitored at the outpatient clinic of Clinical Unit of Cardiomyopathies and Aortic Diseases or Clinical Unit of Hypertension, InCor-HCFMUSP, included by drawing lots into two groups. group A (n=30) will be monitored in biweekly nursing consultations by a period of three months added to the outpatient follow-up, and group B (n = 30) will follow the usual outpatient follow-up. Hypothesis: Patients HF carriers who periodically make telephone consultations of nursing have better quality of life and better therapeutic adherence when compared to patients who only have regular follow-up.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Nurse, Teleconsultation, Heart Failure
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
After filtering this patient database, following the inclusion and exclusion criteria, will be performed randomization in two groups of 30 participants, randomization will be stratified by two variables, Age and Ejection Fraction, using the Jamovi statistical software. Group A will be composed of the participants who will have intervention, that is, the patients will receive fortnightly follow-up in nursing telephone consultation concurrently with follow-up usual outpatient clinic and group B (control) will be composed of the participants who will have no intervention and will continue to monitor according to the institution's routine.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention Group
Arm Type
Active Comparator
Arm Description
Consultations will be carried out via video call, every 15 days for a period of 3 months, with a total of 6 telephone consultations that will have in order to clarify doubts about the CI, the monitoring of possible clinical signs of instability and help in adapting or creating strategies for better adherence to therapy.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Will be composed by the participants who will have no intervention and will continue to monitor according to the institution's routine.
Intervention Type
Behavioral
Intervention Name(s)
Nursing teleconsultation for lifestyle changes
Intervention Description
Guidance on better medication adherence, monitoring of signs and symptoms of exacerbation of heart failure, guidance on the need for fluid restriction.
Primary Outcome Measure Information:
Title
Improvement in the quality of life of patients who receive teleconsultations with a nurse
Description
To analyze this result, the questionnaire Minnesota Living with Heart Failure Questionnaire (MLHFQ) validated in portuguese language will be used. Zero is the minimum value and 105 maximum value, The lower score, represents a better patient's quality of life.
Time Frame
3 months
Title
Improvement in the therapeutic adhesion of patients who receive teleconsultations with a nurse
Description
To analyze this result, the questionnaire European Heart Failure Self-Care Behaviour Scale (EHFScBS) validated in portuguese language will be used. 12 is the minimum value and 60 maximum value, The lower score, represents a better self care.
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients already registered in a database of the Clinical Unit of Cardiomyopathies and Aortic Diseases, InCor - HCFMUSP and Clinical Hypertension Unit - HCFMUSP, in outpatient follow-up for more than a year;
Stroke Volume < 40% and >25%
Exclusion Criteria:
Patientes with Pacemaker, Defibrillators, Implantable and Cardiac Resynchronization Therapy
Listed in heart transplant queue
Not having technological devices that allow the teleconsultation to be carried out
Psychic inability to understand the questionnaires and answer the questions asked by the interviewer
Facility Information:
Facility Name
Heart Institute (InCor), Hospital das Clinicas do HCFMUSP
City
São Paulo
Country
Brazil
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
No share plan
Citations:
PubMed Identifier
32049167
Citation
Gomes BR, Bocchi EA. Quality of Life in Heart Failure: An Important Goal in Treatment. Arq Bras Cardiol. 2020 Jan;114(1):33-34. doi: 10.36660/abc.20190741. No abstract available.
Results Reference
background
PubMed Identifier
25953697
Citation
Fang JC, Ewald GA, Allen LA, Butler J, Westlake Canary CA, Colvin-Adams M, Dickinson MG, Levy P, Stough WG, Sweitzer NK, Teerlink JR, Whellan DJ, Albert NM, Krishnamani R, Rich MW, Walsh MN, Bonnell MR, Carson PE, Chan MC, Dries DL, Hernandez AF, Hershberger RE, Katz SD, Moore S, Rodgers JE, Rogers JG, Vest AR, Givertz MM; Heart Failure Society of America Guidelines Committee. Advanced (stage D) heart failure: a statement from the Heart Failure Society of America Guidelines Committee. J Card Fail. 2015 Jun;21(6):519-34. doi: 10.1016/j.cardfail.2015.04.013. Epub 2015 May 4.
Results Reference
background
PubMed Identifier
28721113
Citation
Rutledge CM, Kott K, Schweickert PA, Poston R, Fowler C, Haney TS. Telehealth and eHealth in nurse practitioner training: current perspectives. Adv Med Educ Pract. 2017 Jun 26;8:399-409. doi: 10.2147/AMEP.S116071. eCollection 2017.
Results Reference
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Nursing Teleconsultation for Patients With Heart Failure
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