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

NCT ID: NCT04892004

Last Updated: 2021-05-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 63 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2017-12-31

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).

Conditions

Heart Failure; Symptoms and Signs

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Control group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventional group

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).

Group Type: EXPERIMENTAL

Symptom recognition

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Instituto Politécnico de Leiria

OTHER

Sponsor Role: lead

Responsible Party

Joana Sousa

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

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.

Reference Type: DERIVED

PMID: 34968218 (View on PubMed)

Other Identifiers

SympRecgHF

Identifier Type: -

Identifier Source: org_study_id