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Decision Making for the Management the Symptoms in Adults of Heart Failure (TOMAS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03549169
Recruitment Status : Active, not recruiting
First Posted : June 7, 2018
Last Update Posted : June 7, 2018
Sponsor:
Information provided by (Responsible Party):
Eugenia Del Pilar Herrera Guerra, Universidad Nacional de Colombia

Brief Summary:

Introduction. Heart failure (HF) is the most prevailing chronic illness in the world. In Colombia, high morbidity and mortality rates because of HF are registered, as well as a significant burden of symptoms, frequent hospitalizations, poor quality of life, significant consumption of health resources and early mortality. It is necessary to propose novel strategies that can change the current picture.

Objective: determine the efficacy of an intervention centered in decision taking for the handling of symptoms in adults with HF who live in the department of Cordoba, Colombia.

Hypothesis

Primary hypothesis: the intervention Decision taking for the handling of symptoms in adults with HF: 1) Increases self-care.

Secondary hypothesis: 1) reduces clinical events: emergency care and hospitalizations, 3) Improves quality of life related to health.


Condition or disease Intervention/treatment Phase
Heart Failure Behavioral: TOMAS Behavioral: Regular attention Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 114 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The participants are assigned to two groups during the duration of the study. A group receives the standard attention and the intervention protocol and the other group only the standard attention.
Masking: Single (Outcomes Assessor)
Masking Description: A research assistant (nurse trained in the measurement instruments) applies the instruments that allow the evaluation of the outcomes of interest: self-care, quality of life regarding health and follow up of clinical events: emergency attention, hospitalization, death by HF.
Primary Purpose: Supportive Care
Official Title: Decision Making for the Management for the Symptoms in Adults of Heart Failure: Randomized Clinical Trial
Actual Study Start Date : September 4, 2017
Estimated Primary Completion Date : May 31, 2018
Estimated Study Completion Date : September 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Experimental: TOMAS
Intervention centered on taking decisions for management of symptoms in adults with Heart Failure. Includes 3 doses (self-care maintenance, symptom perception and symptom management) and 4 strategies are developed: knowledge of the situation, experience and abilities in decision taking and compatibility with personal values.
Behavioral: TOMAS
Intervention focused on decision making for the management of symptoms aimed at adults with heart failure.

Standard or regular attention
Regular attention is centered on education for therapeutic adherence
Behavioral: Regular attention
Regular attention focused on education for therapeutic adherence




Primary Outcome Measures :
  1. Self-care of heart failure index [ Time Frame: Change from baseline self-care for heart failure index at 3 months ]

    The Self-Care of Heart Failure Index is a measure of self-care defined as a naturalistic decision making process involving the choice of behaviors that maintain physiologic stability and the response to symptoms when they occur. A score of ≥70 can be used as the cut-point to judge self-care adequacy.

    We strongly discourage users from calculating a total, combined SCHFI score. Instead, the data will be far more useful if the scales (maintenance, management, confidence) are used individually. Each scale is standardized to a score of 100.

    Use the following formula to compute a standardized:

    Maintenance: (sum of Section A items - 10) * 3.333 Management: (sum of Section B items - 4) * 5 Confidence: (sum of Section C items - 6) * 5.56



Secondary Outcome Measures :
  1. Results in health [ Time Frame: Change from baseline results in health at 3 months ]
    Emergency admissions, hospitalization, death by heart failure

  2. Quality of life related to health [ Time Frame: Change from baselineQuality of life related to health punctuation at 3 months ]

    The Minnesota Living with Heart Failure Questionnaire is one of the most widely used health-related quality of life questionnaires for patients with heart failure (HF). It provides scores for two dimensions, physical and emotional, and a total score. Comprising 21 items rated on six-point Likert scales, representing different degrees of impact of HF on quality of life related to health, from 0 (none) to 5 (very much). It provides a total score (range 0-105, from best to worst HRQoL), as well as scores for two dimensions, physical (8 items, range 0-40) and emotional (5 items, range 0-25). The other eight items (of the totalof 21) are only considered for the calculation of the total score.

    The Minnesota Living with Heart Failure Questionnaire has been translated into and validated in Spanish - Colombia.




Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria

  • Adults (over 18 years of age).
  • More than two months of having been diagnosed.
  • Conserves cognitive state.
  • Absence or low co-morbidity.

Exclusion criteria

  • Confirmed diagnose of acute HF.
  • Confirmed diagnose of advanced HF.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03549169


Locations
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Colombia
Eugenia Herrera Guerra
Montería, Córdoba, Colombia
Sponsors and Collaborators
Universidad Nacional de Colombia
Investigators
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Principal Investigator: EUGENIA HERRERA GUERRA, NURSE Universidad Nacional de Colombia

Additional Information:
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Responsible Party: Eugenia Del Pilar Herrera Guerra, Nurse, Universidad Nacional de Colombia
ClinicalTrials.gov Identifier: NCT03549169     History of Changes
Other Study ID Numbers: UNColombia
First Posted: June 7, 2018    Key Record Dates
Last Update Posted: June 7, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Publication of articles derived from the main study
Supporting Materials: Study Protocol
Clinical Study Report (CSR)
Time Frame: They will be available when the main study ends
Access Criteria: They will be available when the main study ends It can be requested by email

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Eugenia Del Pilar Herrera Guerra, Universidad Nacional de Colombia:
Intervention
Heart Failure
Symptoms management
Selft-care

Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases