The Efficacy and Cost-Effectiveness of Behavioral Counseling for Exercise in Men and Women Following Acute Myocardial Infarction (AMI) and Percutaneous Coronary Intervention (PCI)

Myocardial Infarction Clinical Trial

Official title:

Efficacy and Cost-Effectiveness of Behavioral Counseling For Exercise Behavior in Men and Women Following AMI and PCI

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00250913
• Other study ID #: NA 5626
• Status: Completed
• Phase: Phase 1
• First received: November 7, 2005
• Last updated: November 5, 2010
• Start date: August 2005
• Est. completion date: December 2009

Study information

• Verified date: November 2010
• Source: Ottawa Heart Institute Research Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health CanadaUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Purpose: The purpose of this project is to determine how effective the telephone-based counseling program is at helping patients with heart disease become more physically active.

Hypotheses to be tested:

• Compared to usual care, patients in the physical activity counseling program will:

1. significantly increase total distance measured by an accelerometer and minutes of physical activity at a moderate intensity or higher,

2. have significantly higher generic and heart-disease health-related quality of life, and

3. will lead to greater improvements in the mediators of behavior change (psychosocial variables, i.e. self-efficacy, outcome expectations, etc.) at 26 and 52 weeks;

• Changes in the mediators of physical activity will predict changes in physical activity outcomes at 26 and 52 weeks;

• The physical activity counseling program is preferable to usual care from the perspective of health care system costs.

Description:

Most existing cardiac rehabilitation programs have little ability to expand participation using traditional delivery models that emphasize supervised, facility-based programs. Furthermore, facility-based programs to promote physical activity behavior in patients with coronary artery disease (CAD) are limited in their impact because most patients are unwilling to travel more than 30-45 minutes to participate in a program. The University of Ottawa Heart Institute Prevention and Rehabilitation Centre (Ottawa, Canada) has developed a telephone-based counseling program, specifically to support heart patients in becoming more physically active. The study will involve patients either participating in a 12-month physical activity counseling (PAC) program, or receiving usual care after they are discharged from hospital. For patients assigned to the PAC group, a face-to-face meeting with a physical activity counselor will occur within 10 days to 2 weeks after being discharged from hospital. At this time the patient will be provided with a personalized physical activity program which will be tailored based on prior activity levels, clinical history, and recovery. The PAC patients will also receive eight telephone-based counseling sessions at 2, 4, 8, 14, 20 and 24 weeks, and 2 telephone maintenance contacts at 40 and 52 weeks after hospital discharge. Each telephone call is scheduled to last 10-15 minutes. For patients assigned to the usual care (UC) group, they will receive the physical activity advice and care usually provided to patients discharged from hospital. Following hospitalization, usual care typically includes a follow-up visit(s) with your cardiologist and/or family doctor. If requested, an activity program will be provided to usual care group participants after the study has finished. In addition, the patients will also be required to complete five research questionnaires, and two telephone interviews. The study will track all participants for a period of one year from the time they are discharged from hospital. Over the next twelve months 252 patients from the Ottawa Heart Institute are expected to take part in the study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 304
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 85 Years

Eligibility

Inclusion Criteria:

• Cardiac Diagnosis:

1) hospitalized patients ready for discharge following successful PCI procedure

• Including patients receiving PCI following admission for AMI or hospitalized post-AMI patients who have not been revascularized

• No lesions with >50 % stenosis

• English proficiency in reading, writing and speaking

• Age: 20-85 years

Exclusion Criteria:

• Those patients who are already taking part in another research trial.

• Patient intends to enroll, or is currently enrolled in structured cardiac rehabilitation

• Unable to participate in the on-site cardiac supervised rehab program, cardiac rehab lite, case-managed home cardiac rehab program, Pembroke cardiac rehab program

• Hospitalization for coronary artery bypass (CABG)

• Chronic obstructive pulmonary disease (COPD)

• Hospitalization for diagnostic procedure not associated with previously documented MI

• Patient coming back to hospital for planned staged PCI within 6 months

• Cardiac transplantation

• Presence of, or hospitalization for defibrillator implant

• Hospitalization for pacemaker implantation

• Unresolved unstable angina and/or hospitalization for angina (without MI or PCI)

• Uncontrolled arrhythmias causing symptoms or hemodynamic compromise

• Neuromuscular, musculoskeletal or rheumatoid disorders that are exacerbated by exercise

• Other uncontrolled metabolic conditions (e.g. diabetes)

• Chronic infectious diseases such as mononucleosis, hepatitis, AIDS

• Acute systemic illness or fever

• Uncontrolled tachycardia (<120 bpm)

• Uncompensated congestive heart failure (and/or NYHA Class III, or IV)

• 3rd degree atrioventricular (AV) block (without pacemaker)

• Active pericarditis or myocarditis

• Recent embolism

• Suspected or known abdominal aortic aneurysm (AAA) > 4cm

• Uncontrolled hypertension (systolic blood pressure [SBP] >200; diastolic blood pressure [DBP] >110)

• Pregnancy

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Arteriosclerosis
• Coronary Arteriosclerosis
• Coronary Artery Disease
• Infarction
• Myocardial Infarction
• Myocardial Ischemia

Intervention

Behavioral:
• Telephone-based physical activity counseling program

Locations

Country	Name	City	State
Canada	University of Ottawa Heart Institute	Ottawa	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Ottawa Heart Institute Research Corporation	Heart and Stroke Foundation of Ontario

Country where clinical trial is conducted

Canada, 

References & Publications (9)

Arthur HM, Smith KM, Kodis J, McKelvie R. A controlled trial of hospital versus home-based exercise in cardiac patients. Med Sci Sports Exerc. 2002 Oct;34(10):1544-50. — View Citation

Baranowski T, Anderson C, Carmack C. Mediating variable framework in physical activity interventions. How are we doing? How might we do better? Am J Prev Med. 1998 Nov;15(4):266-97. Review. Erratum in: Am J Prev Med 1999 Jul;17(1):98. — View Citation

Centres for Disease Control. Physical activity and health: Areport of the Surgeon General. Atlanta: National Centre forChronic Disease Prevention and Health Promotion; 1999.

Drummond M, O'Brien BJ, Stoddart G, Torrance G. Methodsfor the Economic Evaluation of Health Care Programmes:Oxford Medical Publications; 1997.

King AC, Stokols D, Talen E, Brassington GS, Killingsworth R. Theoretical approaches to the promotion of physical activity: forging a transdisciplinary paradigm. Am J Prev Med. 2002 Aug;23(2 Suppl):15-25. — View Citation

McLeroy KR, Bibeau D, Steckler A, Glanz K. An ecological perspective on health promotion programs. Health Educ Q. 1988 Winter;15(4):351-77. Review. — View Citation

Sallis JF, Johnson MF, Calfas KJ, Caparosa S, Nichols JF. Assessing perceived physical environmental variables that may influence physical activity. Res Q Exerc Sport. 1997 Dec;68(4):345-51. — View Citation

Stone JA, Cyr C, Friesen M, Kennedy-Symonds H, Stene R, Smilovitch M; Canadian Association of Cardiac Rehabilitation. Canadian guidelines for cardiac rehabilitation and atherosclerotic heart disease prevention: a summary. Can J Cardiol. 2001 Jun;17 Suppl B:3B-30B. — View Citation

Thompson PD, Buchner D, Pina IL, Balady GJ, Williams MA, Marcus BH, Berra K, Blair SN, Costa F, Franklin B, Fletcher GF, Gordon NF, Pate RR, Rodriguez BL, Yancey AK, Wenger NK; American Heart Association Council on Clinical Cardiology Subcommittee on Exercise, Rehabilitation, and Prevention; American Heart Association Council on Nutrition, Physical Activity, and Metabolism Subcommittee on Physical Activity. Exercise and physical activity in the prevention and treatment of atherosclerotic cardiovascular disease: a statement from the Council on Clinical Cardiology (Subcommittee on Exercise, Rehabilitation, and Prevention) and the Council on Nutrition, Physical Activity, and Metabolism (Subcommittee on Physical Activity). Circulation. 2003 Jun 24;107(24):3109-16. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	7-day physical activity levels: waist mounted pedometer will be worn to measure distance (km) over a period of 9 days and will be recorded in an activity log, as well as, reported intensity and duration of activities at a moderate level+
Primary	7-day physical activity recall (PAR): interview administered following the pedometer wear to verify the completeness of the patient recorded activity log and to account for leisure and occupational/domestic activities
Primary	Primary outcomes measured at baseline and 6 and 12 months
Secondary	Psychosocial and Environmental Mediators (questionnaire): psychosocial and environmental mediators of physical activity
Secondary	Quality of Life (questionnaire): heart disease health-related quality of life
Secondary	generic quality of life
Secondary	secondary outcomes measured at baseline and 6 and 12 months
Secondary	Health Care Systems Costs (questionnaire and telephone): the costs of in-person and telephone-based behavioral counseling sessions and any additional health care relating to coronary artery disease (CAD)
Secondary	the use of health care resources will be measured for medical event updates, patient related costs and work absenteeism
Secondary	cost utility analysis to assess for cost per quality-adjusted life year (QALY)
Secondary	measured at 3 (telephone), 6 (questionnaire), 9 (telephone) and 12 (questionnaire) months