Clinical trial NCT01861977: Healthy Habits Program for High Cardiovascular Risk Patients: Randomized Controlled Clinical Trial
Official title: Healthy Habits Program for High Cardiovascular Risk Patients: Randomized Controlled Clinical Trial. Effectiveness of a Program Using Cognitive Behavioral Therapy to Improve Healthy Habits in a Population With Cardiovascular Disease.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Health Behavior
Motor Activity
Food Habits
Keywords: Cognitive Therapy
Health Education
Secondary Prevention
Cardiovascular Disease
Lead sponsor: Hospital Italiano de Buenos Aires
Sponsor class: OTHER
First posted: 2013-05-24
Enrollment: 101
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the effectiveness of a program to improve habits in a population with cardiovascular disease, comparing two different educational techniques (cognitive behavioral therapy group vs. informational workshops).


Eligibility criteria: Inclusion Criteria:

* Patients who live in the catchment area of the health centers participating in the trial or that have their primary care physician in these centers.

or

* Patients with a diagnosis of coronary heart disease, and / or transluminal angioplasty and / or coronary artery bypass grafting (CABG). These diagnoses must have occurred longer than six months from the time of inclusion.

or

* Patients with a diagnosis of cerebrovascular accident (CVA), transient ischemic attack (TIA), carotid endarterectomy and / or carotid angioplasty. These diagnoses must have occurred longer than six months from the time of inclusion.

or

* Patients with peripheral arterial disease with or without intermittent claudication, revascularization surgery, bypass placement of arterial and / or peripheral arterial angioplasty. These diagnoses must have occurred longer than six months from the time of inclusion.

and

* Sedentary persons, defined as less than 90 minutes per week of moderate aerobic physical activity in their daily life (leisure, travel or work).

Exclusion Criteria:

- Patients on chronic home monitoring and / or institutionalized before admission or living in a tertiary institution.

or

* Moderate or severe limitation on functional capacity and / or mobility. or
* Patients with dementia. or
* Patients diagnosed with psychiatric illnesses that compromise patient autonomy. or
* Life expectancy less than 1 year. or
* Patients who do not want to take part in the program. or
* Patients who are participating in another research protocol at recruitment. or
* Patients with a diagnosis of intracranial hemorrhage secondary to aneurysmal rupture.

Primary outcomes:
measure: Achievement of moderate physical activity recommendations
timeFrame: One year
measure: Consumption of fruits and vegetables
timeFrame: One year
Secondary outcomes:
measure: Smoking cessation
timeFrame: One year
measure: Blood pressure control
timeFrame: One year
measure: Lipid Control
timeFrame: One year
measure: Body weight reduction
timeFrame: One year
Other outcomes:
measure: Improvement in health related quality of Life
timeFrame: One year.
measure: Treatment Adherence
timeFrame: One year
Locations:
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: Hospital Italiano de Buenos Aires
state: Caba
Study officials:
affiliation: Hospital Italiano de Buenos Aires
name: Gaston Perman, MD, MSc
role: STUDY_DIRECTOR
affiliation: Hospital Italiano de Buenos Aires
name: Gabriela Buela, MD
role: PRINCIPAL_INVESTIGATOR
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