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

Not Applicable

Completed

• Conditions: Heart Failure; Symptoms and Signs
• Interventions: Behavioral: Symptom recognition

• Registration Number: NCT04892004
• Lead Sponsor: Instituto Politécnico de Leiria

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).

Study Timeline

• Study Start: 2014-09
• Primary Completion: 2015-12-31
• Study Completion: 2017-12-31
• Status Verified: 2021-05
• Study First Submitted: 2021-05-11
• Study First Submitted QC: 2021-05-13
• Last Update Submitted: 2021-05-13
• Study First Posted: 2021-05-19
• Last Update Posted: 2021-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Interventional group	Symptom recognition	A nurse provides the intervention with expertise in Heart Failure and addresses reinforcements on: a) an explanation on signs and symptoms of Heart Failure and how to recognise them; b) importance on daily fluid management, by planning 1.5-2 litres of liquids per day (e.g., soup, milk, coffee, water, tea and yoghurts); and c) when doctors or nurses should be contacted (when symptoms escalation or a weight gain of 2 kg in three days or 5 kg in a week were detected).

Primary Outcome Measures

Name	Time	Method
Self-care behaviors	up to 3 months	Analyze if self-care behaviors are improved
Symptom recognition	up to 3 months	Awareness by a person of the body changes and how they can affect him/her
Emergency and Hospital admissions	up to 3 months	Report if patients with Heart Failure are admitted into hospital or emergency room