Heart Failure(SIHF)NCT04870918
Self-care Intervention for Reducing Rehospitalization for Heart Failure: a Randomized Clinical Trial (SIHF)
A study testing self-care intervention in people with Heart Failure, run by Instituto de Cardiologia do Rio Grande do Sul at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Heart Failure
- What is being tested?
- self-care intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Mar 2019to 1 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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)
- Conditions
- Heart Failure
- Being tested
- self-care intervention
- Keywords
- heart failure, self-care, rehospitalisation
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
self-care interventionBehavioural
Health education will be carried out by the nurse.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rehospitalisation
record of rehospitalizations due to decompensation in 1 year of follow-up; checked in, yes or no and how many times
Measured: 1 year follow up
Secondary outcomes (2)
WHOQOL BREF
It consists of 26 questions whose answers follow a Likert scale (from 1 to 5, the higher the score the better the quality of life), the score therefore varies from 26 to 130 points.
Measured: difference between baseline data and at 1 year of follow-up
Pos traumatic grown factor
It is a series of questions that evaluate the intensity through a likert scale from 0 to 5, the score ranges from 0 to 105.
Measured: difference between baseline data and at 1 year of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2021
- Study start1 Mar 2019
- Primary completion1 Jun 2021
- Study completion1 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto de Cardiologia do Rio Grande do Sul
- Sponsor type
- University, hospital or other
- Collaborators
- Universidade de Caxias do Sul
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04870918
- Sponsor's protocol ID
- UP 5630/19
- Acronym
- (SIHF)
- Status last verified
- Jun 2023
- First submitted
- 17 Nov 2020
- Last updated
- 29 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36917484
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self-care Intervention for Reducing Rehospitalization for Heart Failure: a Randomized Clinical Trial (SIHF)
- ClinicalTrials.gov ID
- NCT04870918
- Acronym / sponsor ID
- (SIHF) / UP 5630/19
- Conditions
- Heart Failure
- Keywords
- heart failure, self-care, rehospitalisation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Instituto de Cardiologia do Rio Grande do SulUniversity, hospital or other
- Collaborators
- Universidade de Caxias do Sul
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 1 Jun 2021 (actual)
- Study completion
- 1 Jun 2021 (actual)
- First posted
- 4 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- One group will have self-care guidelines and the other will not. Medical appointments will be the same for both groups.
| Arm | Type | Receives |
|---|---|---|
| self-care intervention | Experimental | Behavioral: self-care interventionFirst, 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. |
| 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. |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| self-care interventionHealth education will be carried out by the nurse. | Behavioural | self-care intervention |
Primary outcome
Rehospitalisation
Time frame: 1 year follow up
record of rehospitalizations due to decompensation in 1 year of follow-up; checked in, yes or no and how many times
2 secondary outcomes
WHOQOL BREF
Time frame: difference between baseline data and at 1 year of follow-up
Pos traumatic grown factor
Time frame: difference between baseline data and at 1 year of follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2023.
- Derived from this study: PubMed 36917484de 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing self-care intervention in people with Heart Failure, run by Instituto de Cardiologia do Rio Grande do Sul at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rehospitalisation (time frame: 1 year follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04870918, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2023.