Self-care Intervention for Reducing Rehospitalization for Heart Failure: a Randomized Clinical Trial (SIHF)

NCT04870918 | Completed

• 1 other identifier: UP 5630/19
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Heart Failure

Keywords

heart failure; self-care; rehospitalisation

Outcome Measures

Primary Outcomes (1)

• Rehospitalisation

  record of rehospitalizations due to decompensation in 1 year of follow-up; checked in, yes or no and how many times

  1 year follow up

Secondary Outcomes (2)

• WHOQOL BREF

  difference between baseline data and at 1 year of follow-up

• Pos traumatic grown factor

  difference between baseline data and at 1 year of follow-up

Study Arms (2)

self-care intervention

EXPERIMENTAL

First, health education will be carried out by the nurse. 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.

Behavioral: self-care intervention

usual care

NO INTERVENTION

The control group will go through medical consultations as instructed by the doctor and will not receive intervention for health education by the nurse.

Interventions

self-care intervention BEHAVIORAL

Health education will be carried out by the nurse.

self-care intervention

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients (≥ or equal to 18 years) will be included, who were admitted to any ward or intensive care unit (ICU) of this hospital (for the cardiology team) and who have been identified as having HF indicated by the attending physician via medical records. electronic

You may not qualify if:

• Octogenarians and / or communication barriers will be excluded from the analysis (due to the difficulty of self-management of the signs and symptoms, in contrast to the objective to be studied), patients do not accept to participate in the study.

Sponsors & Collaborators

• Instituto de Cardiologia do Rio Grande do Sul: lead
• Universidade de Caxias do Sul: collaborator

Study Sites (1)

Marcia Moura Schmidt

Porto Alegre, Rio Grande do Sul, 90620-000, Brazil

Location

Related Publications (1)

• de Oliveira FW, Nunes BP, Lobato FL, Schmidt MM. Psychoeducational Intervention for Reducing Heart Failure Patients' Rehospitalizations and Promoting Their Quality of Life and Posttraumatic Growth at the 1-Year Follow-Up: A Randomized Clinical Trial. Psychosom Med. 2023 Apr 1;85(3):273-279. doi: 10.1097/PSY.0000000000001180. Epub 2023 Feb 26.

  PMID: 36917484 DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: There will be blinding to assess outcomes, that is, review of medical records and phone calls in order to have knowledge about rehospitalization.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: One group will have self-care guidelines and the other will not. Medical appointments will be the same for both groups.

Study Record Dates

• First Submitted: November 17, 2020
• First Posted: May 4, 2021
• Study Start: March 1, 2019
• Primary Completion: June 1, 2021
• Study Completion: June 1, 2021
• Last Updated: June 29, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)