Heart Failure Clinical Trial
— RETURN-001Official title:
Effectiveness of Telenursing Program on Lung Function of Heart Failure Patients: a Randomized Clinical Trial Protocol
Verified date | February 2016 |
Source | Federal University of Bahia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 156 |
Est. completion date | March 2016 |
Est. primary completion date | April 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. With prior medical diagnosis of heart failure with functional class I, II or III, in accordance to New York Heart Association (NYRA)8. 2. 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. 3. With dyspnoea or spirometric volumes evidencing deterioration of lung function. 4. With cognitive conditions to be interviewed. 5. With no medical restrictions to perform spirometry testing and six-minute walk test. 6. With clinical control of the heart failure. Exclusion Criteria: 1. With psychiatric disorders; 2. Who do not meet eligibility criteria after run-in period; 3. With severe acute or chronic pulmonary disease; 4. Who change clinical parameters during the data collection (severe dyspnoea, peripherical oxygen saturation below 95%). |
Country | Name | City | State |
---|---|---|---|
Brazil | Ana nery Hospital | Salvador | Bahia |
Lead Sponsor | Collaborator |
---|---|
Federal University of Bahia | Fundação de Amparo à Pesquisa do Estado da Bahia |
Brazil,
Riley JP, Gabe JP, Cowie MR. Does telemonitoring in heart failure empower patients for self-care? A qualitative study. J Clin Nurs. 2013 Sep;22(17-18):2444-55. doi: 10.1111/j.1365-2702.2012.04294.x. Epub 2012 Nov 27. — View Citation
Rodríguez-Gázquez Mde L, Arredondo-Holguín E, Herrera-Cortés R. Effectiveness of an educational program in nursing in the self-care of patients with heart failure: randomized controlled trial. Rev Lat Am Enfermagem. 2012 Mar-Apr;20(2):296-306. English, Portuguese, Spanish. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Lung function volumes | Evaluation will be done in the V6 compared to V1, only. Baseline has no spirometry test | Expected average of 6 months | |
Secondary | Related quality of life | Minnesota living with heart failure questionnaire | Expected average of 6 months | |
Secondary | Functional capacity | Functional capacity will be evaluated using Six-minutes walking test. Visits are done monthly (avarage) | Expected average of 6 months | |
Secondary | Morbidity | Telenursing monitoring occurs every week during six months in the intervention group (24 weeks) | Weekly during telenursing monitoring (Expected average of 6 months) | |
Secondary | Mortality | Telenursing monitoring occurs every week during six months in the intervention group (24 weeks) | Weekly durng telenursing monitoring program (Expected average of 6 months) |
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