Decision Making for the Management the Symptoms in Adults of Heart Failure (TOMAS)
|ClinicalTrials.gov Identifier: NCT03549169|
Recruitment Status : Unknown
Verified June 2018 by Eugenia Del Pilar Herrera Guerra, Universidad Nacional de Colombia.
Recruitment status was: Active, not recruiting
First Posted : June 7, 2018
Last Update Posted : June 7, 2018
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.
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||114 participants|
|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|
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.
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
- 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
- Results in health [ Time Frame: Change from baseline results in health at 3 months ]Emergency admissions, hospitalization, death by heart failure
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03549169
|Eugenia Herrera Guerra|
|Montería, Córdoba, Colombia|
|Principal Investigator:||EUGENIA HERRERA GUERRA, NURSE||Universidad Nacional de Colombia|