Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Heart Failure
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: One group will have self-care guidelines and the other will not. Medical appointments will be the same for both groups.Masking: Single (Outcomes Assessor)Masking Description: There will be blinding to assess outcomes, that is, review of medical records and phone calls in order to have knowledge about rehospitalization.Primary Purpose: Supportive Care

Participation Requirements

Age
Between 30 years and 75 years
Gender
Both males and females

Description

Adult patients (? or equal to 18 years old), who were admitted to any ward or intensive care unit (ICU) for the cardiology team, and who have been identified as having HF will be included. Octogenarians and / or with communication barriers will be excluded (due to the difficulty of self-management o...

Adult patients (? or equal to 18 years old), who were admitted to any ward or intensive care unit (ICU) for the cardiology team, and who have been identified as having HF will be included. Octogenarians and / or with communication barriers will be excluded (due to the difficulty of self-management of signs and symptoms, not in line with the objective to be studied) and still not accept to participate in the study. Upon discharge, patients with HF will leave the hospital with a date and time to return to the HF outpatient clinic. At the time of the first medical consultation, patients will complete a screening instrument (Appendix A) that contains information about: age; sex; breed; origin (city); inpatient for the cardiology team; length of hospital stay; cause of hospitalization; laboratory values (urea and creatinine); echocardiographic data up to 1 year before admission: left ventricular ejection fraction (LVEF); associated comorbidities, medications for continuous use, daily practices related to physical exercise, sodium intake, smoking, body weight, classification according to the New York Heart Association (NYHA), and a brief report on its understanding of the disease (HF) and its strategic control of warning signs and symptoms; After filling in these data, patients will be invited to participate in the study. Those who accept it, signing the IC (Annex B), will answer the following instruments: WHOQOL-BREF and ICPT. In order of date and time when signing the informed consent form, patients will be randomized in 1: 1, with odd numbers designated for treatment A (intervention for self-care) and even numbers designated for treatment B conventional treatment 24. From the second consultation, patients will be treated differently: Control Group: The control group will undergo medical consultations as instructed by the attending physician and will not receive intervention for health education by the nurse. Intervention group: First, health education will be carried out by the nurse, explaining the importance of daily body weight control, inspecting the ankles for swelling, preventing respiratory diseases (flu vaccine), eating low-salt foods, control of the amount of liquid ingested, the need to follow the schedule and the correct dose of the prescribed drugs. In the third consultation, the patient will be evaluated regarding follow-up with the correct diet, intake of controlled fluids, consistency with the use of medications (explaining the purpose of each). Check with the patient his ability to remain free of the symptoms of the disease, the follow-up of the treatment, if he recognizes any change that signals an aggravation of the disease (explaining about the dangerous signs and symptoms that must be observed by the patient). From the fourth consultation, an explanatory brochure will be delivered which denotes the signs and symptoms that should be observed and when to seek outpatient service in order to avoid an aggravation of the disease by postponing an apparent symptom. Guidance will be given in relation to quality of life, changes in lifestyle, investigating the patient's support network and internal changes in relation to their view of life and spirituality from the diagnosis of the disease. The consultations will be individual, weekly (Wednesdays), the others, therefore, will be biweekly, extending to the 30/30 days the following, individually in order to observe the difficulties and doubts of each patient. Counting the meetings in a total of 12 in the first 6 months. After the end of the treatment, the patients will be followed in order to verify the occurrence of new hospitalizations in 6 months and in 1 year. At the end of 12 months, the instruments will be replicated.WHOQOL_BREF: The WHOQOL-BREF consists of 26 questions whose answers follow a Likert scale (from 1 to 5, the higher the score the better the quality of life). Questions 1 and 2 deal with general quality of life. Apart from these two questions (1 and 2), the instrument has 24 more questions which make up 4 domains which are: PHYSICAL, PSYCHOLOGICAL, SOCIAL RELATIONSHIPS and ENVIRONMENT25. (Annex C) Post-Traumatic Growth Inventory (ICPT): Post-traumatic growth consists of the idea that when experiencing an adverse situation, such as becoming ill or worsening health conditions, the person can positively change the way they see and relate with the world. (ICPT) is a self-report scale that evaluates 5 domains, being: Relationship with others (7 items, ex: "I have a clearer idea that I can count on people in times of difficulty"); New possibilities (5 items, ex: "I developed new interests"); Personal Change (4 items, ex: "I know I can handle difficulties better"), Spiritual Change (2 items, ex: "I have a better understanding of spiritual issues") and Greater appreciation of life (3 items, ex: " I get to enjoy each day better "). The responses follow a Likert scale (from 0 to 5, from "I did not experience this change ..." to "I completely experienced this change as a result of the event" 26) (Annex D)

Tracking Information

NCT #
NCT04870918
Collaborators
Universidade de Caxias do Sul
Investigators
Not Provided