Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03549169
Other study ID # UNColombia
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 4, 2017
Est. completion date March 30, 2019

Study information

Verified date June 2021
Source Universidad Nacional de Colombia
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

Intervention: The theoretic approach of the Theory of the Specific Situation Self-care in HF was used for the design of the intervention. Supplier/dosage/duration. The intervention was given by the researcher (nurse trained in the intervention protocol) in three doses, each contact lasts 60 minutes. Frequency: sessions are given once a week during a one-month period (duration). Nurse controls are implemented after the intervention after one month and three months. There is also telephonic accompaniment on application of the participant. Delivery method/environment. Verbal: Individual face to face. Printed educational written material type brochure, outpatient clinic of a health institution. Methodology Participants: inclusion criteria: adults (over the age of 18 years), more than two months of having been diagnosed; functional New York Heart Association (NYHA) Class II - III, left ventricular ejection fraction reduced (<40%). Cognitive state conservation (Lobo cognitive mini exam - MEC-35). Absence or low co-morbidity (Charlson index). Exclusion criteria: acute HF, advanced HF Sample: The study was designed to have a 90% output, (alpha = 0.05), an expected difference of 0.5 in the outcome score of the management and maintenance evaluation in both groups, a standard deviation of outcome scores of 1.0, a correlation average between the first and the second evaluation of 0.2 and a rate of wear of 20%. Therefore, the required final sample size was 124 (62 per group - theoretic sample). Pilot study: 176 adults with HF were recruited. 114 entered the study. 62 were excluded (did not meet the inclusion criteria (n=39), did not want to participate (=14), other reasons (n=9)). Randomization. Table of random numbers without repetition. The Participants randomly assigned to the control group CG (n=57) received the standard attention, including standard education given by attention providers, and the ones assigned to the intervention group IG (n=57) received the intervention protocol. Information collection (research assistant). The study registers information in the following time points: beginning (base line), follow up after a month (outpatient appointment), follow up after 3 months (outpatient appointment). The study is classified as simple blind; the research assistant, who is in charge of applying the instrument measuring the effect of the intervention, will remain blinded during the whole study regarding the group assigned to each participant. Risk control. Compliance with methodological recommendations used to guarantee reliability and validity of the research studies proving a clinic intervention for behavioral changes. A plan is being contemplated that includes goals and strategies to monitor and counter possible threats to internal and external validity. Ethical aspects. Compliance with universal ethical principles for research on humans, according to international ethical guidelines - CIOMS, national regulations, informed consent and deontological Nursing responsibilities in Colombia. Analysis framework Excel database - SPSS Program analysis 1. Descriptive analysis of the total sample and by groups (intervention and control): absolute and relative frequency distributions; median and standard deviation. 2. Data normality analysis: Kolmogorov-Smirnov test Statistical analysis for independent samples a) difference of proportions: X2, b) difference of means: t for student, c) difference of medians: U test of Mann - Whitney. In all cases a statistic significance will be assumed if the value p < 0.05. 3. Intrasubject and intergroup analysis: ANOVA with repeated measurements. 4. Hypothesis proof: W of Mauchly test. When the sphericity premise is fulfilled, test F will be used. 5. Analysis of possible confusion and/or interaction effect. 1. Stratified analysis: X2 of Mantel-Haenszel (M-H), 2. Logistic regression analysis. Stepwise method. Minimum change % considered as favorable (≥20=1, ≤19=0). 6. Analysis of the magnitude of the intervention's effect. Improvement of at least 20% of the score on the scale, with the analysis principle of the intention of trying. The absolute increase in benefit and the necessary number for treatment (NNT) will be calculated afterwards.


Recruitment information / eligibility

Status Completed
Enrollment 114
Est. completion date March 30, 2019
Est. primary completion date December 31, 2018
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
TOMAS
Intervention focused on decision making for the management of symptoms aimed at adults with heart failure.
Regular attention
Regular attention focused on education for therapeutic adherence

Locations

Country Name City State
Colombia Eugenia Herrera Guerra Montería Córdoba

Sponsors (1)

Lead Sponsor Collaborator
Universidad Nacional de Colombia

Country where clinical trial is conducted

Colombia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Self-care of heart failure index 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
Change from baseline self-care for heart failure index at 3 months
Secondary Results in health Emergency admissions, hospitalization, death by heart failure Change from baseline results in health at 3 months
Secondary Quality of life related to health 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.
Change from baselineQuality of life related to health punctuation at 3 months
See also
  Status Clinical Trial Phase
Recruiting NCT05196659 - Collaborative Quality Improvement (C-QIP) Study N/A
Recruiting NCT05654272 - Development of CIRC Technologies
Recruiting NCT05650307 - CV Imaging of Metabolic Interventions
Active, not recruiting NCT05896904 - Clinical Comparison of Patients With Transthyretin Cardiac Amyloidosis and Patients With Heart Failure With Reduced Ejection Fraction N/A
Completed NCT05077293 - Building Electronic Tools To Enhance and Reinforce Cardiovascular Recommendations - Heart Failure
Recruiting NCT05631275 - The Role of Bioimpedance Analysis in Patients With Chronic Heart Failure and Systolic Ventricular Dysfunction
Enrolling by invitation NCT05564572 - Randomized Implementation of Routine Patient-Reported Health Status Assessment Among Heart Failure Patients in Stanford Cardiology N/A
Enrolling by invitation NCT05009706 - Self-care in Older Frail Persons With Heart Failure Intervention N/A
Recruiting NCT04177199 - What is the Workload Burden Associated With Using the Triage HF+ Care Pathway?
Terminated NCT03615469 - Building Strength Through Rehabilitation for Heart Failure Patients (BISTRO-STUDY) N/A
Recruiting NCT06340048 - Epicardial Injection of hiPSC-CMs to Treat Severe Chronic Ischemic Heart Failure Phase 1/Phase 2
Recruiting NCT05679713 - Next-generation, Integrative, and Personalized Risk Assessment to Prevent Recurrent Heart Failure Events: the ORACLE Study
Completed NCT04254328 - The Effectiveness of Nintendo Wii Fit and Inspiratory Muscle Training in Older Patients With Heart Failure N/A
Recruiting NCT05572814 - Transform: Teaching, Technology, and Teams N/A
Enrolling by invitation NCT05538611 - Effect Evaluation of Chain Quality Control Management on Patients With Heart Failure
Recruiting NCT04262830 - Cancer Therapy Effects on the Heart
Completed NCT06026683 - Conduction System Stimulation to Avoid Left Ventricle Dysfunction N/A
Withdrawn NCT03091998 - Subcu Administration of CD-NP in Heart Failure Patients With Left Ventricular Assist Device Support Phase 1
Recruiting NCT05564689 - Absolute Coronary Flow in Patients With Heart Failure With Reduced Ejection Fraction and Left Bundle Branch Block With Cardiac Resynchronization Therapy
Completed NCT04549181 - Problem-Solving for Rural Heart Failure Dyads N/A