Self-care Intervention for Reducing Rehospitalization for Heart Failure: a Randomized Clinical Trial (SIHF)
Condition: Heart Failure
MeSH terms: Heart Failure
Study type: Interventional

Summary: 
      Introduction: Heart failure (HF) is considered an epidemic with high morbidity and mortality
      that imposes limitations on affected individuals, decreases the quality of life, restricts
      social life and makes it difficult to carry out daily activities including work. Almost 50%
      of diagnosed patients are readmitted in less than 90 days after discharge. Therefore,
      rehospitalization is considered as a predictive cause of the increased risk of intrahospital
      death in patients hospitalized with HF due to underlying disease. Related to chronic
      diseases, self-care is essential in maintaining physical and psychological well-being because
      it corroborates the success of the treatment. The patient's observational and resolving
      capacity is necessary in view of the appearance of signs and symptoms that would be postponed
      or alienated and would end up in hospital. Objective: To verify whether an intervention
      focused on self-care reduces the number of readmissions, improves quality of life and
      provides greater post-traumatic growth in patients with HF. Method: Randomized clinical
      trial, parallel by intention to treat, with blinding for evaluation of outcomes. Adult
      patients who were admitted to a Hospital in the Serra Gaúcha and who were identified as
      having HF by the attending physician will be included. Upon discharge, patients will leave
      the hospital with a date and time to return to the HF Ambulatory. In the first consultation,
      patients will be invited to participate in the study and will answer a nursing screening
      instrument and the following instruments: WHOQOL-BREF and ICPT (respectively, quality of life
      and post-traumatic growth). In order of date and time when signing the informed consent form,
      patients will be randomized in 1: 1. From the second consultation, the intervention group
      will be followed up for guidance on the disease and treatment, totaling 12 sessions in 6
      months. The control group will go through medical consultations as instructed by the doctor
      and will not receive intervention for health education by the nurse. 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 1 year the instruments will be
      replicated. Results: It is expected to enable the patient to remain free of the symptoms of
      the disease, following the prescribed treatment and being able to recognize any changes that
      signal an aggravation of the disease. It is hoped that the intervention in health education
      can decrease the rate of rehospitalization of patients, improve the quality of life and
      provide greater post-traumatic growth in patients with HF.
    

Detailed 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 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)
    

Intervention name(s): self-care intervention
Intervention type(s): Behavioral
Intervention description(s): Health education will be carried out by the nurse.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention 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)
Primary purpose: Supportive Care
Keywords: heart failure; self-care; rehospitalisation