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Symptom Recognition Improves Self-care in Patients With Heart Failure.

Does Symptom Recognition Improve Self-care in Patients With Heart Failure. A Growth Latent Model

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04892004
Enrollment
63
Registered
2021-05-19
Start date
2014-09-30
Completion date
2017-12-31
Last updated
2021-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure, Symptoms and Signs

Keywords

Heart failure, Self-care behaviors, Symptom recognition, Nurse-led program

Brief summary

Describe a behaviour intervention to analyse self-care engagement in heart failure patients. Allocate patients with heart failure into 2 arms study: a control group and an intervention group.

Detailed description

According to medical record at admission, a pilot study was described and included 63 patients in New York Heart Association (NYHA) functional class II-III. Patients were recruited in a hospital setting after discharge from a heart failure unit. Patients were allocated into a control group (n=33) and an intervention group (n=30) through the computerised random allocation generator at http://random.org. The pilot study was performed during three months per patient, with four moments of assessment (baseline, first-week follow-up, first-month follow-up, third-month follow-up).

Interventions

BEHAVIORALSymptom recognition

The patient receives a leaflet, which includes information about HF, primary symptoms, awareness of its detection and the fluid management plan. It also receives a weight diary, which helps him/her recall weight fluctuation and contact the nurse or doctor to call for help in a previous stage and avoid hospitalisation. Patients have to explain what they understand by HF, on follow-ups contacts, which are the main symptoms, if they are experiencing any of them and which difficulties managing fluid restriction and weight control. The leading investigator validates the information and teaches back contents if required.

Sponsors

Instituto Politécnico de Leiria
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* adults aged \>18 years old, with diagnosed HF and with no cognitive disability associated.

Exclusion criteria

* patients placed on the heart transplant waiting list and patients in class IV NYHA.

Design outcomes

Primary

MeasureTime frameDescription
Symptom recognitionup to 3 monthsAwareness by a person of the body changes and how they can affect him/her
Self-care behaviorsup to 3 monthsAnalyze if self-care behaviors are improved
Emergency and Hospital admissionsup to 3 monthsReport if patients with Heart Failure are admitted into hospital or emergency room

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 15, 2026