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

Primary Purpose

Heart Failure, Symptoms and Signs

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Symptom recognition
Sponsored by
CiTechCare
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Heart Failure focused on measuring Heart failure, Self-care behaviors, Symptom recognition, Nurse-led program

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    Control group

    Interventional group

    Arm Description

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

    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).

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Full Information

    First Posted
    May 11, 2021
    Last Updated
    May 13, 2021
    Sponsor
    CiTechCare
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04892004
    Brief Title
    Symptom Recognition Improves Self-care in Patients With Heart Failure.
    Official Title
    Does Symptom Recognition Improve Self-care in Patients With Heart Failure. A Growth Latent Model
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2014 (Actual)
    Primary Completion Date
    December 31, 2015 (Actual)
    Study Completion Date
    December 31, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    CiTechCare

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Heart Failure, Symptoms and Signs
    Keywords
    Heart failure, Self-care behaviors, Symptom recognition, Nurse-led program

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    63 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Control group
    Arm Type
    No Intervention
    Arm Description
    Standard information defined as the standard care, unplanned, provided for Heart Failure patients and not personalized.
    Arm Title
    Interventional group
    Arm Type
    Experimental
    Arm Description
    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).
    Intervention Type
    Behavioral
    Intervention Name(s)
    Symptom recognition
    Intervention Description
    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 Outcome Measure Information:
    Title
    Symptom recognition
    Description
    Awareness by a person of the body changes and how they can affect him/her
    Time Frame
    up to 3 months
    Title
    Self-care behaviors
    Description
    Analyze if self-care behaviors are improved
    Time Frame
    up to 3 months
    Title
    Emergency and Hospital admissions
    Description
    Report if patients with Heart Failure are admitted into hospital or emergency room
    Time Frame
    up to 3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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.

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    34968218
    Citation
    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.
    Results Reference
    derived

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

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