Mobile Health For Pacemaker Patientes

Cardiovascular Diseases Clinical Trial

— MHOL  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04582058
• Other study ID #: MHOL
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 22, 2018
• Est. completion date: November 20, 2022

Study information

• Verified date: August 2021
• Source: InCor Heart Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 90
• Est. completion date: November 20, 2022
• Est. primary completion date: November 20, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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;

Related Conditions & MeSH terms

• Anxiety Disorders
• Cardiovascular Diseases
• Depressive Disorder
• Disease
• Quality of Life
• Sedentary Behavior

Intervention

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.

Locations

Country	Name	City	State
Brazil	Martino Martinelli Filho	São Paulo	Sao Paulo

Sponsors (2)

Lead Sponsor	Collaborator
InCor Heart Institute	Spectator Healthcare Technology

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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