Heart Failure Clinical Trial
Official title:
Effectiveness of Telenursing Program on Lung Function of Heart Failure Patients: a Randomized Clinical Trial Protocol
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.
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:
1. To participate in a telenursing education program;
2. To fill-in a diary of symptoms and signs, daily;
3. To receive calls from the research team weekly;
4. To have attendance at appointment between window of 15 days before or after the
scheduled date;
5. 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
After beginning the project, patients who present the following criteria must be excluded:
1. Pregnancy;
2. Hospitalization for more than 30 days;
3. Do not attend monthly visit inside the search window of 15 days before or after the
scheduled date;
4. To change of residence address among states that preclude attendance at scheduled
visits;
5. Death;
6. To discharge outpatient clinic of the Hospital of study;
7. Subsequent diagnostic of acute or chronic respiratory disease or other physical/mental
condition that makes it impossible to participate in the study;
8. To Cease to participate in telenursingprogram or that study.
RANDOMIZATION
The sample size calculation was performed in Sealed Envelope TM program. 156 patients will be
needed (78 per group), using the following indicators: confidence level 95%, 5% maximum error
permitted, statistical power of 90% for detecting elevation of the primary endpoint by 12% in
the experimental group. After applying the inclusion and exclusion criteria, two groups will
be sourced from the randomization and will be allocated into case group and control group
without replacement. All subjects included will be assigned a three-digit sequential number
(eg. 000-999). These numbers will be fed into groups of four patients with similar
characteristics. After that, blok size randomization will be procedure in specific software
(www.randomization.com).
INTERVENTIONS The control group will receive standard treatment and monitoring for heart
failure from the ambulatory staff where the study will be performed, including
pharmacotherapy and health education, as recommended by the health team. The intervention
group will receive the standard treatment and ongoing follow-up as well as monitoring by
telenursing for a period of 6 months (24 weeks).
The application of remote nursing monitoring program shall establish contact with the
participants for six months, through weekly telephone contacts on days and times to be
accorded between them. We expected duration of 5 to 10 minutes per call. The team that
performs the intervention will explain the content of foreseen contacts with educational
approach, allowing the participant a moment to comment and clarification of final questions.
After conclusion of the study, the control group also will receive telenursing intervention
if it is proven benefits through this study. The protocol for telenursing intervention
deployed can continue in the specialized outpatient clinic and other chronic diseases
programs, if proven their benefit.
Implementation of the Program of Telenursing The program of telenursing will consist in
weekly contact with patients with heart failure with functional class I, II and III. For the
development of telenursing, it will be distributed to the study staff a protocol for remote
monitoring practices in nursing and a form of individualized remote monitoring (appendix A
and B). Intervention group will be receive educational and support materials (educational
booklet and diary of signs and symptoms).
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.
The telenursing program protocol is based on: 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.
The protocol is individualized according to the needs identified in the monthly consultation
and/or weekly contact for telenursing calls. The protocol addresses the themes: information
of health education about the pathology; monitoring the signs and symptoms; adherence to
treatment; healthy eating and weight control; breathing exercises; cardiovascular and
pulmonary risk factors; physical, occupational and sexual activity; emotional and social
support. It functions as a guiding instrument for telenursing, and it is useful in the
clinical management of diseases, improvement of self-care, strengthening communication and
humanization in relations between professionals and users of health services.
These items will be addressed in alternate calls to avoid wear and loss of information over
the phone. Before finalizing the calls, will be offered the individual a moment to express
doubts or make other settings regarding the intervention. The nurse is expected to write a
report at the end of the calls, by checking the form of individual remote monitoring. All
calls will be recorded through Skype and MP3 Skype Recorder software.
The educational booklet containing information about the heart failure and a diary of
symptoms and signs will be distributed to the participants, being nurse attribution explain
it to them. The booklet developed is a support material for conducting health education by
telenursing, illustrated, aimed at answer typical questions, easy to handle and transport,
simple visual communication, including to be accessible to individuals with limited
understanding of written language. It is a suitable material for the use of the individual as
well as the assistance of parents, family members, caregivers and other health professionals
and students.
Moreover, after the first contact, will be developed an intervention plan for each
individual, according to the needs identified after analysis of medical records and for the
nursing consultation. The plan may be modified according to the needs that are identified
through the telenursing calls.
Procedures BASELINE: First a baseline period will be held in which, for all individuals
enrolled in the study. Following questionnaires will be applied: sociodemographic and
clinical characterization formulary; quality of life (Minnesota Living with Heart Failure
Questionnaire - MLHFQ); Baseline Dyspnoea Index by Mahler; and electrocardiogram will be
performed. When all participants pass through the baseline period, will be preceded
randomization and implementation of Visit 01.
Also in this period, a pilot of the telenursing will be made, in which seven study
participants will undergo intervention in order to identify necessary changes and
adjustments.
VISIT 01 (start of run-in):
For both groups: Application of structured interviews for data collection of
socio-demographic and clinical characterization formulary; Application of quality of life
questionnaire (MLHFQ); The questionnaire of Baseline Dyspnea Index by Mahler; Conducting
pulmonary function test spirometry by a technician certified by the Brazilian Society of
Pulmonology; Achievement Test six-minute walk; Measurement of clinical data (pulse oximetry,
electrocardiogram, measurement of anthropometric data).
Intervention group: will be explained and distributed a educational booklet and a journal of
signs and symptoms. Remote monitoring procedures with nursing continuing education will be
explained, collecting best times of contact, collecting phones (personal, neighbors, to run
errands, pay phone in the street of residence and mobile phone). On this same visit
individuals will be informed of the weekly telephone monitoring and monthly outpatients seen
for six months.
Will be provided a standardized health Education for the control group and the intervention
group.
VISIT 02, 03, 04, 05:
For both groups: in the days of their regular attendance in the ambulatory will be held:
standardized education; reviewed medical clinic (the regular ambulatory); the questionnaires
and scales (MLHFQ and Baseline Dyspnoea Index Mahler).
Intervention group: The sessions once a month will be held during the six months of data
collection. There will be continuity of telenursing directed to continuing education, weekly.
VISIT 06: all related procedures will be carried out in other visits and additionally walk
test six minutes, spirometry, electrocardiogram and pulse oximetry.
ASSESSMENT
1. Sphygmomanometer - Brand: Missouri.
2. Electrocardiograph - Brand: EMAI - Model: 3-channel, 12 simultaneous leads, Graphic
Display: LCD 12.8 x 6.4 cm, 12 Outlets EX03.
3. Portable Spirometer for Lung Function Assessment, Brand: KOKO MOE FERRARIS USB.
4. Stethoscope - Brand: Missouri
5. Pulse Oximeter - Brand: Oxilife, Model: Plus Cmos Drake
6. Notebook, Intel Core i5-3210M processor 2.5 GHz, 6GB Memory, 750GB HD, 14-inch LED
screen.
7. Headphone - Brand: Trust Model: Quasar 16904.
STATISTICAL ANALYSIS PLAN Descriptive statistics will be used to characterize the individuals
search. The analysis of continuous variables will be through measures of central tendency and
dispersion; categorical variables will be analyzed using proportions. The difference between
proportions will be calculated using the chi-square test. Association tests will be
performed. For correlations, the Pearson or Spearman tests depending on the normality of
information or number of empty cells are proceeded. Additionally, the risk factors are
analyzed according to the cutoff score of quality of life. We will use multivariate linear
regression to verify association between risk factors and QoL. FIT equations will be done.
There will be also analysis by protocol and by intention to treat. Analyzes stratified by age
also compose the statistical plan. The information collected will be fed into a database and
analyzed using SPSS 20.0 software (Statistical Package for Social Sciences). Statistically
significant values with an interval of confidence greater than or equal to 95% will be
considered.
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