Mobile Health For Pacemaker Patientes (MHOL)
Primary Purpose
Cardiovascular Diseases, Sedentary Behavior, Anxiety Disorders
Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Mobile Health of lifestyle
Sponsored by
About this trial
This is an interventional treatment trial for Cardiovascular Diseases focused on measuring cardiovascular disease, Mobile Health
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;
Sites / Locations
- Martino Martinelli Filho
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control Group (CG)
Interventional Group (IG)
Arm Description
Control Group (CG): Standard of care, normally follow up, without mobile health
Interventional Group (IG): Mobile Health to patients with an orientation about daily activities and protocol of physical exercise
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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).
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.
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.
Full Information
NCT ID
NCT04582058
First Posted
October 4, 2020
Last Updated
August 24, 2021
Sponsor
InCor Heart Institute
Collaborators
Spectator Healthcare Technology
1. Study Identification
Unique Protocol Identification Number
NCT04582058
Brief Title
Mobile Health For Pacemaker Patientes
Acronym
MHOL
Official Title
Mobile Health of Lifestyle to Patients With Cardiac Electronic Implantable Device: Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 22, 2018 (Actual)
Primary Completion Date
November 20, 2022 (Anticipated)
Study Completion Date
November 20, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
InCor Heart Institute
Collaborators
Spectator Healthcare Technology
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Diseases, Sedentary Behavior, Anxiety Disorders, Depressive Disorder, Quality of Life
Keywords
cardiovascular disease, Mobile Health
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control Group (CG)
Arm Type
No Intervention
Arm Description
Control Group (CG): Standard of care, normally follow up, without mobile health
Arm Title
Interventional Group (IG)
Arm Type
Experimental
Arm Description
Interventional Group (IG): Mobile Health to patients with an orientation about daily activities and protocol of physical exercise
Intervention Type
Behavioral
Intervention Name(s)
Mobile Health of lifestyle
Intervention Description
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.
Primary Outcome Measure Information:
Title
Functional exercise capacity
Description
Six walk minutes test to assess and measures the distance that patient can walk on a flat in a period of 6 minutes
Time Frame
Six minutes
Secondary Outcome Measure Information:
Title
Quality of life of patients
Description
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).
Time Frame
Thirty minutes
Title
Anxiety and depression
Description
Hospital anxiety and depression scale, which consist 14 questions that evaluate how patients felt during the previous week. Scores with range 0-21.
Time Frame
Thirty minutes
Title
Level of physical activity
Description
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.
Time Frame
Thirty minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martino MM Martinelli Filho, PHD
Organizational Affiliation
InCor Heart Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Martino Martinelli Filho
City
São Paulo
State/Province
Sao Paulo
ZIP/Postal Code
05403-900
Country
Brazil
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Mobile Health For Pacemaker Patientes
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