Mobile Health For Pacemaker Patientes

NCT ID: NCT04582058

Last Updated: 2021-08-30

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-22
• Study Completion Date: 2022-11-20

Brief Summary

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.

Detailed 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.

Conditions

Cardiovascular Diseases; Sedentary Behavior; Anxiety Disorders; Depressive Disorder; Quality of Life

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control Group (CG)

Control Group (CG): Standard of care, normally follow up, without mobile health

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventional Group (IG)

Interventional Group (IG): Mobile Health to patients with an orientation about daily activities and protocol of physical exercise

Group Type: EXPERIMENTAL

Mobile Health of lifestyle

Intervention Type: BEHAVIORAL

Mobile health of lifestyle with an orientation about daily activities and necessary care to patients with CEID, and protocol of exercise training with images and guidelines to execute five days per week, with a duration of 50 minutes, and space for doubts which patients could send message to researcher.

Interventions

Mobile Health of lifestyle

Mobile health of lifestyle with an orientation about daily activities and necessary care to patients with CEID, and protocol of exercise training with images and guidelines to execute five days per week, with a duration of 50 minutes, and space for doubts which patients could send message to researcher.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Spectator Healthcare Technology

UNKNOWN

Sponsor Role: collaborator

InCor Heart Institute

OTHER

Sponsor Role: lead

Responsible Party

Martino Martinelli Filho

MD, PHD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Martino MM Martinelli Filho, PHD

Role: PRINCIPAL_INVESTIGATOR

InCor Heart Institute

Locations

Martino Martinelli Filho

São Paulo, São Paulo, Brazil

Countries

Brazil

Other Identifiers

MHOL

Identifier Type: -

Identifier Source: org_study_id