Decision Making for the Management for the Symptoms in Adults of Heart Failure: Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 114
- 试验地点
- 1
- 主要终点
- Self-care of heart failure index
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Self-care of heart failure index
时间窗: 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
次要结局
- Quality of life related to health(Change from baselineQuality of life related to health punctuation at 3 months)
- Results in health(Change from baseline results in health at 3 months)