Decision Making for the Management the Symptoms in Adults of Heart Failure

NCT03549169 | Completed

• 1 other identifier: UNColombia
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure

Keywords

Intervention; Heart Failure; Symptoms management; Selft-care

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Results in health

  Change from baseline results in health at 3 months

• Quality of life related to health

  Change from baselineQuality of life related to health punctuation at 3 months

Study Arms (2)

TOMAS

EXPERIMENTAL

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

Standard or regular attention

OTHER

Regular attention is centered on education for therapeutic adherence

Behavioral: Regular attention

Interventions

TOMAS BEHAVIORAL

Intervention focused on decision making for the management of symptoms aimed at adults with heart failure.

TOMAS

Regular attention BEHAVIORAL

Regular attention focused on education for therapeutic adherence

Standard or regular attention

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Universidad Nacional de Colombia: lead

Study Sites (1)

Eugenia Herrera Guerra

Montería, Departamento de Córdoba, Colombia

Location

Related 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

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• EUGENIA HERRERA GUERRA, NURSE

  Universidad Nacional de Colombia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 24, 2018
• First Posted: June 7, 2018
• Study Start: September 4, 2017
• Primary Completion: December 31, 2018
• Study Completion: March 30, 2019
• Last Updated: July 2, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, 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

Locations

CO (1)