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

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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Symptoms and Signs

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Symptom recognition

Behavioral

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.

Primary outcomes

Symptom recognition

Time frame: up to 3 months

Awareness by a person of the body changes and how they can affect him/her
Self-care behaviors

Time frame: up to 3 months

Analyze if self-care behaviors are improved
Emergency and Hospital admissions

Time frame: up to 3 months

Report if patients with Heart Failure are admitted into hospital or emergency room

Sponsors and collaborators

Lead sponsor

Instituto Politécnico de Leiria

Other

Registry information

Official study title

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

Important dates

Study start: 2014
Primary completion: 2015
Study completion: 2017
First posted: May 19, 2021
Registry last updated: May 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed