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Mobile Health For Pacemaker Patientes (MHOL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04582058
Recruitment Status : Active, not recruiting
First Posted : October 9, 2020
Last Update Posted : August 30, 2021
Sponsor:
Collaborator:
Spectator Healthcare Technology
Information provided by (Responsible Party):
Martino Martinelli Filho, InCor Heart Institute

Study Description
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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.

Condition or disease Intervention/treatment Phase
Cardiovascular Diseases Sedentary Behavior Anxiety Disorders Depressive Disorder Quality of Life Behavioral: Mobile Health of lifestyle Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Interventional Group (IG): Mobile Health to patients with an orientation about daily activities and protocol of physical exercise Control Group (CG): normally follow up, without mobile health
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Mobile Health of Lifestyle to Patients With Cardiac Electronic Implantable Device: Randomized Clinical Trial
Actual Study Start Date : May 22, 2018
Estimated Primary Completion Date : November 20, 2022
Estimated Study Completion Date : November 20, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Functional exercise capacity [ Time Frame: Six minutes ]
    Six walk minutes test to assess and measures the distance that patient can walk on a flat in a period of 6 minutes


Secondary Outcome Measures :
  1. Quality of life of patients [ Time Frame: Thirty minutes ]
    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).

  2. Anxiety and depression [ Time Frame: Thirty minutes ]
    Hospital anxiety and depression scale, which consist 14 questions that evaluate how patients felt during the previous week. Scores with range 0-21.

  3. Level of physical activity [ Time Frame: Thirty minutes ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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;
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04582058


Locations
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Brazil
Martino Martinelli Filho
São Paulo, Sao Paulo, Brazil, 05403-900
Sponsors and Collaborators
InCor Heart Institute
Spectator Healthcare Technology
Investigators
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Principal Investigator: Martino MM Martinelli Filho, PHD InCor Heart Institute
More Information
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Responsible Party: Martino Martinelli Filho, MD, PHD, InCor Heart Institute
ClinicalTrials.gov Identifier: NCT04582058    
Other Study ID Numbers: MHOL
First Posted: October 9, 2020    Key Record Dates
Last Update Posted: August 30, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Martino Martinelli Filho, InCor Heart Institute:
cardiovascular disease
Mobile Health
Additional relevant MeSH terms:
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Cardiovascular Diseases
Disease
Depressive Disorder
Anxiety Disorders
 Pathologic Processes
Mood Disorders
Mental Disorders