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

NCT04892004 | Completed

• 1 other identifier: SympRecgHF
• Study Type: interventional
• Target: 63
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Heart Failure; Symptoms and Signs

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Symptom recognition

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

  up to 3 months

• Self-care behaviors

  Analyze if self-care behaviors are improved

  up to 3 months

• Emergency and Hospital admissions

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

  up to 3 months

Study Arms (2)

Control group

NO INTERVENTION

Standard information defined as the standard care, unplanned, provided for Heart Failure patients and not personalized.

Interventional group

EXPERIMENTAL

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).

Behavioral: Symptom recognition

Interventions

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.

Interventional group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Instituto Politécnico de Leiria: lead

Related Publications (1)

• Pereira Sousa J, Neves H, Pais-Vieira M. Does Symptom Recognition Improve Self-Care in Patients with Heart Failure? A Pilot Study Randomised Controlled Trial. Nurs Rep. 2021 Jun 1;11(2):418-429. doi: 10.3390/nursrep11020040.

  PMID: 34968218 DERIVED

MeSH Terms

Conditions

Heart Failure; Signs and Symptoms

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: May 11, 2021
• First Posted: May 19, 2021
• Study Start: September 1, 2014
• Primary Completion: December 31, 2015
• Study Completion: December 31, 2017
• Last Updated: May 19, 2021

Record last verified: 2021-05