REmoTe TelenURsiNg on Lung Function of Heart Failure Outpatients

NCT02387190 | Unknown

• 1 other identifier: RETURN-001
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Heart Failure

Keywords

Heart Failure; Lung function test; Telenursing; Morbidity; Mortality; Quality of life

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Related quality of life

  Expected average of 6 months

• Functional capacity

  Expected average of 6 months

• Morbidity

  Weekly during telenursing monitoring (Expected average of 6 months)

• Mortality

  Weekly durng telenursing monitoring program (Expected average of 6 months)

Study Arms (2)

Telenursing monitoring

EXPERIMENTAL

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.

Other: Telenursing monitoring

Control group

NO INTERVENTION

Placebo is considered as standardized education

Interventions

Telenursing monitoring OTHER

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.

Telenursing monitoring

Eligibility Criteria

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

You may qualify if:

• With prior medical diagnosis of heart failure with functional class I, II or III, in accordance to New York Heart Association (NYRA)8.
• 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.

You may not qualify if:

• 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%).

Sponsors & Collaborators

• Federal University of Bahia: lead
• Fundação de Amparo à Pesquisa do Estado da Bahia: collaborator

Study Sites (1)

Ana nery Hospital

Salvador, Estado de Bahia, 40296720, Brazil

Location

Related Publications (2)

• Rodriguez-Gazquez Mde L, Arredondo-Holguin E, Herrera-Cortes 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. doi: 10.1590/s0104-11692012000200012. English, Portuguese, Spanish.

  PMID: 22699730 BACKGROUND

• 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.

  PMID: 23185992 BACKGROUND

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Carolina Souza-Machado, PhD

  Federal University of Bahia

  STUDY CHAIR

• Carolina Santos, NP

  Federal University of Bahia

  PRINCIPAL INVESTIGATOR

• Bárbara Sueli Moreira, NP

  Federal University of Bahia

  PRINCIPAL INVESTIGATOR

• Loyane Stenzel, NP

  Federal University of Bahia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: NP, PhD

Study Record Dates

• First Submitted: May 14, 2014
• First Posted: March 12, 2015
• Study Start: November 1, 2013
• Primary Completion: April 1, 2015
• Study Completion: March 1, 2016
• Last Updated: February 12, 2016

Record last verified: 2016-02

Locations

BR (1)