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Mobile Health For Pacemaker Patientes (MHOL)

U

University of São Paulo (USP)

Status

Unknown

Conditions

Quality of Life
Cardiovascular Diseases
Anxiety Disorders
Depressive Disorder
Sedentary Behavior

Treatments

Behavioral: Mobile Health of lifestyle

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

Previous studies suggested that most patients with Cardiac Electronic Implantable devices have a perception of describing the lifestyle due to a limitation of daily activities and physical exercise, besides the consequences in the psychological aspects such as anxiety and depression. The MHOL-CEID is a randomized controlled trial that Verifies the effectiveness of the Mobile Health of lifestyle that focuses on aspects of physical functional, psychosocial, and quality of life of patients with Cardiac Electronic Implantable Device.

Full description

Cardiovascular diseases represent one of the main causes of death in the Brazilian population, as well as dysfunctions of the heart conduction system. In an attempt to treat and correct heart conduction system dysfunctions, Cardiac Electronic Implantable Device (CEID) was developed. Most people with CEID have a perception of describing the lifestyle due to a limitation of daily activities and physical exercise, besides the consequences in the psychological aspects such as anxiety and depression. These changes in the psychosocial conduct of patients with CEID are due to the lack of knowledge and the lack of effective guidance, being of fundamental importance to elaborate the resources of education in health for patients with CEID. Health promotion through educational intervention is a recognized strategy and an Internet approach to the mobile health proposal is a recognized and promising practice.

This randomized controlled study is been conducted to verify the effectiveness of the Mobile Health of lifestyle that focuses on aspects of physical functional, psychosocial, and quality of life of patients with CEID. The hypothesis is that the use of Mobile Health of lifestyle provides greater physical functional, psychological aspects, and quality of life to patients with CIED.

Enrollment

90 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Written informed consent prior to randomization and any study procedure;
  • Patients with any CIED
  • Access to the internet
  • Clinical stability in the last 3 weeks
  • With left ventricular ejection fraction (LVEF) greater than 40%
  • Skill to conduct the self-monitoring of intensity in physical activity
  • New York Heart Association classification 1 or 2

Exclusion criteria

  • Unstable angina
  • Uncontrolled systemic arterial hypertension
  • Cardiac arrhythmia effort- induced
  • People with a musculoskeletal or neurological problem
  • Cognitive disability
  • Patients opposed to the participation in the research
  • Other concomitants cardiovascular disease, including uncontrolled diabetes mellitus (systemic hypertension without target-organ impairment is allowed);
  • Moderate or severe chronic obstructive pulmonary disease;

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

90 participants in 2 patient groups

Control Group (CG)
No Intervention group
Description:
Control Group (CG): Standard of care, normally follow up, without mobile health
Interventional Group (IG)
Experimental group
Description:
Interventional Group (IG): Mobile Health to patients with an orientation about daily activities and protocol of physical exercise
Treatment:
Behavioral: Mobile Health of lifestyle

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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