Effectiveness of Telenursing Program on Lung Function of Heart Failure Patients: a Randomized Clinical Trial Protocol
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 156
- 试验地点
- 1
- 主要终点
- Lung function volumes
研究概览
简要总结
Pulmonary dysfunction presented in patients with heart failure is observed as a decrease of maximal aerobic capacity compared to healthy people. Lung function deterioration manifests, in the presence of muscle fatigue and dyspnea on exertion, loss of functional capacity, and activities limitation of daily living. Those manifestation influence the perception of quality of life of patients1.
Patients with heart failure need to develop changes in lifestyle and daily activities aiming to maintain clinical control and prevent the onset of complications and disabilities. If these changes are not often performed, they might carry bigger burden to for the individual and their family and for the healthcare system due to increasing of morbidity and mortality between those patients2.
Systematic reviews conducted in developed countries (USA3, UK4 and Canada5) and developing countries (Colombia6) have shown that telehealth can produce positive effects in individuals with chronic diseases as heart failure. This kind of intervention seems to be effective in preventing hospitalizations and non-elective emergency visits.
In Brazil, telenursing is still a non-standardized and non-diffused intervention. In this perspective, telenursing represents soft new tools to provide quality care. It certainly allows the orientation and training of patients, the permanence of them at home, reduces unnecessary hospitalization. Additionally, this intervention, allows the management of nursing time and strengthens their professional autonomy7.
The principal aim of this study is to describe the protocol to be used in MRE study. The objective of MRE trial is to test the hypothesis that telenursing contributes to the improvement in lung function over the medium term, in patients with heart failure under continuous education.
详细描述
METHODS STUDY DESIGN It will be a blinded- controlled-randomized clinical trial in parallel-group, with six months follow-up. The trial protocol will be performed in referral outpatient center that accompany patients with heart failure. This unit is part of the public health system in the city of Salvador - Bahia, the second largest city in Northeast of Brazil. The Brazilian health system is one of the largest public health systems in the world. Ensures full access, universal and free to the entire population of the country. Bolstered by a broader concept of health, the health system was created in 1988 by the Brazilian Federal Constitution, to be the health system of more than 180 million Brazilians.
Run-in
The run-in period will last 15 days. After the run-in, eligible patients will be part of the study, according the following criteria:
- To participate in a telenursing education program;
- To fill-in a diary of symptoms and signs, daily;
- To receive calls from the research team weekly;
- To have attendance at appointment between window of 15 days before or after the scheduled date;
- To be predisposed to performing spirometry testing, six-minute walk test, pulse oximetry, electrocardiography, and to respond questionnaires about quality of life and scales of dyspnoea.
Wash out
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •With prior medical diagnosis of heart failure with functional class I, II or III, in accordance to New York Heart Association (NYRA)
- •In regular follow-up for at least six months at the study site. Regular follow will be considered when in the period of six months the individual attend at least 2/3 of the scheduled appointments of outpatient unit and 100% of run-in period appointments.
- •With dyspnoea or spirometric volumes evidencing deterioration of lung function.
- •With cognitive conditions to be interviewed.
- •With no medical restrictions to perform spirometry testing and six-minute walk test.
- •With clinical control of the heart failure.
排除标准
- •With psychiatric disorders;
- •Who do not meet eligibility criteria after run-in period;
- •With severe acute or chronic pulmonary disease;
- •Who change clinical parameters during the data collection (severe dyspnoea, peripherical oxygen saturation below 95%).
研究组 & 干预措施
Telenursing monitoring
The protocol for telenursing allows the realization of standardized professional contacts with the patient and educational approach It is possible through questions and answers coded, that indicate the need for educational intervention or reinforcement of appropriate health behavior.1) Contact the patient by telephone, weekly; 2) Distribution and explanation of the educational booklet; 3) Filling a diary of symptoms and signs; 4) Record, management and markdown visits in case of non-elective visits, hospitalization or fatal episodes. Also, the following aspects shall be observed: help requests associated with illness, adaptations for living with the disease, effects of drugs in daily life, availability of financial resources for disease management, self-image; emotional and social support.
干预措施: Telenursing monitoring (Other)
Control group
Placebo is considered as standardized education
结局指标
主要结局
Lung function volumes
时间窗: Expected average of 6 months
Evaluation will be done in the V6 compared to V1, only. Baseline has no spirometry test
次要结局
- Mortality(Weekly durng telenursing monitoring program (Expected average of 6 months))
- Related quality of life(Expected average of 6 months)
- Morbidity(Weekly during telenursing monitoring (Expected average of 6 months))
- Functional capacity(Expected average of 6 months)
研究者
Carolina de Souza-Machado
NP, PhD
Federal University of Bahia