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

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04892004
• Other study ID #: SympRecgHF
• Status: Completed
• Phase: N/A
• Start date: September 2014
• Est. completion date: December 31, 2017

Study information

• Verified date: May 2021
• Source: CiTechCare
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: December 31, 2017
• Est. primary completion date: December 31, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Heart Failure
• Symptoms and Signs

Intervention

Behavioral:
• Symptom 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
CiTechCare

Outcome

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