Mobile Health For Pacemaker Patientes (MHOL)

Mobile Health of Lifestyle to Patients With Cardiac Electronic Implantable Device: Randomized Clinical Trial

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Depressive Disorder; Cardiovascular Diseases; Quality of Life; Anxiety Disorders; Sedentary Behavior
• Intervention / Treatment: Behavioral: Mobile Health of lifestyle

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.

• Study Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Sao Paulo
    • São Paulo, Sao Paulo, Brazil, 05403-900
      • Martino Martinelli Filho

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: Control Group (CG); Control Group (CG): Standard of care, normally follow up, without mobile health
EXPERIMENTAL: Interventional Group (IG); Interventional Group (IG): Mobile Health to patients with an orientation about daily activities and protocol of physical exercise	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional exercise capacity	Six walk minutes test to assess and measures the distance that patient can walk on a flat in a period of 6 minutes	Six minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life of patients	SF 36 questionnaire, evaluate health-related quality of life. The SF-36 measures eight scales: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH).	Thirty minutes
Anxiety and depression	Hospital anxiety and depression scale, which consist 14 questions that evaluate how patients felt during the previous week. Scores with range 0-21.	Thirty minutes
Level of physical activity	IPAQ questionnaire, • To assesses the types of intensity of physical activity and sitting time that patients do on daily lives activities, and are considered to estimate total physical activity in MET-min/week and time spent sitting.	Thirty minutes

Collaborators and Investigators

• Sponsor: InCor Heart Institute
• Collaborators: Spectator Healthcare Technology
• Investigators: Principal Investigator: Martino MM Martinelli Filho, PHD, InCor Heart Institute

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 22, 2018
• Primary Completion (ANTICIPATED): November 20, 2022
• Study Completion (ANTICIPATED): November 20, 2022

Study Registration Dates

• First Submitted: October 4, 2020
• First Submitted That Met QC Criteria: October 4, 2020
• First Posted (ACTUAL): October 9, 2020

Study Record Updates

• Last Update Posted (ACTUAL): August 30, 2021
• Last Update Submitted That Met QC Criteria: August 24, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Mobile Health; cardiovascular disease
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Mood Disorders; Depressive Disorder; Cardiovascular Diseases; Disease; Anxiety Disorders
• Other Study ID Numbers: MHOL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No