Healthy Habits Program for High Cardiovascular Risk Patients: Randomized Controlled Clinical Trial

Health Behavior 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01861977
• Other study ID #: 2009
• Status: Completed
• Phase: N/A
• Start date: June 2013
• Est. completion date: January 2016

Study information

• Verified date: February 2024
• Source: Hospital Italiano de Buenos Aires
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Food Habits
• Health Behavior
• Motor Activity

Intervention

Behavioral:
• Cognitive Behavioral Therapy
Participants in this arm will be invited to attend 8 weekly group meetings and 3 monthly follow-up meetings. In each meeting a coordinator will explore the experiences of the participants and encourage them to look for strategies to solve problems associated with changing habits. In the meetings we will use a therapeutic education approach with motivational interviewing techniques and problem solving in order to increase self-efficacy and motivation to adopt healthy habits. There will be periodic reminders and telephone contacts with patients before the meetings to assess the achievement of objectives.
• Informational Workshop
Participants will be invited to participate in 4 weekly group meetings and an additional reinforcing meeting in the 5th month. In each meeting, workshop techniques will be used, together with educational materials as brochures, pictures, etc. The informational material will focus on the benefits of lifestyle changes in diet and physical activity.

Locations

Country	Name	City	State
Argentina	Hospital Italiano de Buenos Aires	Ciudad Autónoma de Buenos Aires	Caba

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Italiano de Buenos Aires

Country where clinical trial is conducted

Argentina, 

References & Publications (11)

Barth J, Schneider S, von Kanel R. Lack of social support in the etiology and the prognosis of coronary heart disease: a systematic review and meta-analysis. Psychosom Med. 2010 Apr;72(3):229-38. doi: 10.1097/PSY.0b013e3181d01611. Epub 2010 Mar 11. — View Citation

Berkman LF, Blumenthal J, Burg M, Carney RM, Catellier D, Cowan MJ, Czajkowski SM, DeBusk R, Hosking J, Jaffe A, Kaufmann PG, Mitchell P, Norman J, Powell LH, Raczynski JM, Schneiderman N; Enhancing Recovery in Coronary Heart Disease Patients Investigators (ENRICHD). Effects of treating depression and low perceived social support on clinical events after myocardial infarction: the Enhancing Recovery in Coronary Heart Disease Patients (ENRICHD) Randomized Trial. JAMA. 2003 Jun 18;289(23):3106-16. doi: 10.1001/jama.289.23.3106. — View Citation

Clark AM, Hartling L, Vandermeer B, McAlister FA. Meta-analysis: secondary prevention programs for patients with coronary artery disease. Ann Intern Med. 2005 Nov 1;143(9):659-72. doi: 10.7326/0003-4819-143-9-200511010-00010. — View Citation

Furie KL, Kasner SE, Adams RJ, Albers GW, Bush RL, Fagan SC, Halperin JL, Johnston SC, Katzan I, Kernan WN, Mitchell PH, Ovbiagele B, Palesch YY, Sacco RL, Schwamm LH, Wassertheil-Smoller S, Turan TN, Wentworth D; American Heart Association Stroke Council, Council on Cardiovascular Nursing, Council on Clinical Cardiology, and Interdisciplinary Council on Quality of Care and Outcomes Research. Guidelines for the prevention of stroke in patients with stroke or transient ischemic attack: a guideline for healthcare professionals from the american heart association/american stroke association. Stroke. 2011 Jan;42(1):227-76. doi: 10.1161/STR.0b013e3181f7d043. Epub 2010 Oct 21. — View Citation

Gulliksson M, Burell G, Vessby B, Lundin L, Toss H, Svardsudd K. Randomized controlled trial of cognitive behavioral therapy vs standard treatment to prevent recurrent cardiovascular events in patients with coronary heart disease: Secondary Prevention in Uppsala Primary Health Care project (SUPRIM). Arch Intern Med. 2011 Jan 24;171(2):134-40. doi: 10.1001/archinternmed.2010.510. — View Citation

Holt-Lunstad J, Smith TB, Layton JB. Social relationships and mortality risk: a meta-analytic review. PLoS Med. 2010 Jul 27;7(7):e1000316. doi: 10.1371/journal.pmed.1000316. — View Citation

Ismail K, Winkley K, Rabe-Hesketh S. Systematic review and meta-analysis of randomised controlled trials of psychological interventions to improve glycaemic control in patients with type 2 diabetes. Lancet. 2004 May 15;363(9421):1589-97. doi: 10.1016/S0140-6736(04)16202-8. — View Citation

Lim HK, Foltz RL. In vivo formation of aromatic hydroxylated metabolites of 3,4-(methylenedioxy)methamphetamine in the rat: identification by ion trap tandem mass spectrometric (MS/MS and MS/MS/MS) techniques. Biol Mass Spectrom. 1991 Nov;20(11):677-86. doi: 10.1002/bms.1200201105. — View Citation

Morisky DE, Green LW, Levine DM. Concurrent and predictive validity of a self-reported measure of medication adherence. Med Care. 1986 Jan;24(1):67-74. doi: 10.1097/00005650-198601000-00007. — View Citation

Rosengren A, Hawken S, Ounpuu S, Sliwa K, Zubaid M, Almahmeed WA, Blackett KN, Sitthi-amorn C, Sato H, Yusuf S; INTERHEART investigators. Association of psychosocial risk factors with risk of acute myocardial infarction in 11119 cases and 13648 controls from 52 countries (the INTERHEART study): case-control study. Lancet. 2004 Sep 11-17;364(9438):953-62. doi: 10.1016/S0140-6736(04)17019-0. — View Citation

Smith SC Jr, Benjamin EJ, Bonow RO, Braun LT, Creager MA, Franklin BA, Gibbons RJ, Grundy SM, Hiratzka LF, Jones DW, Lloyd-Jones DM, Minissian M, Mosca L, Peterson ED, Sacco RL, Spertus J, Stein JH, Taubert KA. AHA/ACCF secondary prevention and risk reduction therapy for patients with coronary and other atherosclerotic vascular disease: 2011 update: a guideline from the American Heart Association and American College of Cardiology Foundation endorsed by the World Heart Federation and the Preventive Cardiovascular Nurses Association. J Am Coll Cardiol. 2011 Nov 29;58(23):2432-46. doi: 10.1016/j.jacc.2011.10.824. Epub 2011 Nov 3. No abstract available. Erratum In: J Am Coll Cardiol. 2015 Apr 14;65(14):1495. Dosage error in article text. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Improvement in health related quality of Life	Perception of quality of life will be assessed through EuroQol questionnaire (validated in Spanish). It will analyze the difference (final-basal) between the two groups. The visual analog scale ranges from 0 (worse quality of life possible) to 100 (best possible state).	One year.
Other	Treatment Adherence	Maintaining adherence to prescribed drug treatments: adherence to drug treatment will be evaluated through Medication Adherence Questionnaire. It will analyze the final difference (final-basal) between the two groups.	One year
Primary	Achievement of moderate physical activity recommendations	Moderate physical activity: minutes per week measured by the questionnaire WHO STEP wise (Physical activity at work/in the household, for transport and during leisure time; minimum 0; the grater the better).	One year
Primary	Consumption of fruits and vegetables	Consumption of fruits and vegetables: number of servings per day measured by questionnaire WHO STEP wise (minimum 0; optimal 5 or more).	One year
Secondary	Smoking cessation	Smoking cessation: will be considered if patients report smoking abstinence (no smoking consumption for the last three months), at the end of the study.	One year
Secondary	Blood pressure control	Blood pressure will be considered controlled if systolic blood pressure values are lower than 140 mmHg and/or if there is a decrease in at least 5% from basal at the end of the program.	One year
Secondary	Lipid Control	LDL cholesterol will be considered controlled if the patient has LDL values below 100 mg/dl or a reduction of at least 20% from basal at the end of the program.	One year
Secondary	Body weight reduction	Reducing at least 5% from basal of body weight at endpoint in those patients with a body mass index (BMI) in a value greater than 30 kg/m2 at baseline.	One year