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

Decision Making for the Management for the Symptoms in Adults of Heart Failure: Randomized Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Heart Failure
• Intervention / Treatment: Behavioral: TOMAS; Behavioral: Regular attention

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 114
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Colombia
  • Córdoba
    • Montería, Córdoba, Colombia
      • Eugenia Herrera Guerra

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.
Other: Standard or regular attention; Regular attention is centered on education for therapeutic adherence	Behavioral: Regular attention; Regular attention focused on education for therapeutic adherence

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Results in health	Emergency admissions, hospitalization, death by heart failure	Change from baseline results in health at 3 months
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

Collaborators and Investigators

• Sponsor: Universidad Nacional de Colombia
• Investigators: Principal Investigator: EUGENIA HERRERA GUERRA, NURSE, Universidad Nacional de Colombia

Publications and helpful links

Helpful Links

• Riegel, B., Lee, C. S., Dickson, V. V., & Carlson, B. (2009). An Update on the Self-Care of Heart Failure Index. The Journal of Cardiovascular Nursing, 24(6), 485-497
• Riegel, B., Dickson, V., & Faulkner., K. (2016). The Situation-Specific Theory of Heart Failure Self-Care: Revised and Updated. The Journal of Cardiovascular Nursing, 31(3), 226-235. doi: 10.1097/JCN.0000000000000244

Study record dates

Study Major Dates

• Study Start (Actual): September 4, 2017
• Primary Completion (Actual): December 31, 2018
• Study Completion (Actual): March 30, 2019

Study Registration Dates

• First Submitted: March 24, 2018
• First Submitted That Met QC Criteria: June 5, 2018
• First Posted (Actual): June 7, 2018

Study Record Updates

• Last Update Posted (Actual): July 2, 2021
• Last Update Submitted That Met QC Criteria: June 29, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: Heart Failure; Intervention; Symptoms management; Selft-care
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: UNColombia

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Publication of articles derived from the main study
• IPD Sharing Time Frame: They will be available when the main study ends
• IPD Sharing Access Criteria: They will be available when the main study ends It can be requested by email
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No