Coronary ArteriosclerosisPhase 1NCT00250913
The Efficacy and Cost-Effectiveness of Behavioral Counseling for Exercise in Men and Women Following Acute Myocardial Infarction (AMI) and Percutaneous Coronary Intervention (PCI)
A Phase 1 study testing Telephone-based physical activity counseling program in people with Coronary Arteriosclerosis and Myocardial Infarction, run by Ottawa Heart Institute Research Corporation at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Coronary Arteriosclerosis, Myocardial Infarction
- What is being tested?
- Telephone-based physical activity counseling program
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 304 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2005to Dec 2009
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 24Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Cost-Effectiveness of Behavioral Counseling For Exercise Behavior in Men and Women Following AMI and PCI
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:
Read more
- Compared to usual care, patients in the physical activity counseling program will:
- significantly increase total distance measured by an accelerometer and minutes of physical activity at a moderate intensity or higher,
- have significantly higher generic and heart-disease health-related quality of life, and
- 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.
Read the detailed 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.
- Conditions
- Coronary Arteriosclerosis, Myocardial Infarction
- Being tested
- Telephone-based physical activity counseling program
- Keywords
- motor activity, determinants, psychology, health care costs, quality of life, Angioplasty
- Medical subject headings
- Coronary Artery Disease, Myocardial Infarction, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telephone-based physical activity counseling programBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
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+
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 outcomes measured at baseline and 6 and 12 months
Secondary outcomes (8)
Psychosocial and Environmental Mediators (questionnaire): psychosocial and environmental mediators of physical activity
Quality of Life (questionnaire): heart disease health-related quality of life
generic quality of life
secondary outcomes measured at baseline and 6 and 12 months
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)
the use of health care resources will be measured for medical event updates, patient related costs and work absenteeism
cost utility analysis to assess for cost per quality-adjusted life year (QALY)
measured at 3 (telephone), 6 (questionnaire), 9 (telephone) and 12 (questionnaire) months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2005 (estimated)
- Study startAug 2005
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Coronary ArteriosclerosisStudies of the same condition, open and under way.
- More trials run by Ottawa Heart Institute Research CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 304 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ottawa Heart Institute Research Corporation
- Sponsor type
- University, hospital or other
- Collaborators
- Heart and Stroke Foundation of Ontario
- Investigators
- Robert Reid, PhD, MBA, Principal investigator, Ottawa Heart Institute Research CorporationLouise Morrin, RPT, MBA, Study chair, Ottawa Heart Institute Research CorporationLyall Higginson, MD, FRCP(C), Study chair, Ottawa Heart Institute Research CorporationAndrew Pipe, MD, Study chair, The University of Ottawa Heart InstituteAndreas Wielgosz, MD, FRCP(C), Study chair, The Ottawa General Hospital - Department of Cadiology - General CampusNeil Oldridge, PhD, Study chair, College of Health Sciences, University of Wisconsin-MilwaukeeGeorge Wells, PhD, Study chair, Clinical Epidemiology Unit, University of Ottawa Heart InstituteChris Blanchard, PhD, Study chair, Department of Human Kinetics, University of Ottawa & University of Ottawa Heart Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00250913
- Sponsor's protocol ID
- NA 5626
- Status last verified
- Nov 2010
- First submitted
- 7 Nov 2005
- Last updated
- 9 Nov 2010
- Results posted
- No
Publications
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. doi: 10.1016/s0749-3797(98)00080-4.
PubMed 9838973Arthur 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. doi: 10.1097/00005768-200210000-00003.
PubMed 12370553Drummond M, O'Brien BJ, Stoddart G, Torrance G. Methodsfor the Economic Evaluation of Health Care Programmes:Oxford Medical Publications; 1997.
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. doi: 10.1161/01.CIR.0000075572.40158.77. No abstract available.
PubMed 12821592Centres for Disease Control. Physical activity and health: Areport of the Surgeon General. Atlanta: National Centre forChronic Disease Prevention and Health Promotion; 1999.
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.
PubMed 11420586McLeroy KR, Bibeau D, Steckler A, Glanz K. An ecological perspective on health promotion programs. Health Educ Q. 1988 Winter;15(4):351-77. doi: 10.1177/109019818801500401.
PubMed 3068205Sallis 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. doi: 10.1080/02701367.1997.10608015.
PubMed 9421846King 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. doi: 10.1016/s0749-3797(02)00470-1.
PubMed 12133734
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Cost-Effectiveness of Behavioral Counseling For Exercise Behavior in Men and Women Following AMI and PCI
- ClinicalTrials.gov ID
- NCT00250913
- Acronym / sponsor ID
- NA 5626
- Conditions
- Coronary Arteriosclerosis, Myocardial Infarction
- Keywords
- motor activity, determinants, psychology, health care costs, quality of life, Angioplasty
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 304 participants (estimated)
- Lead sponsor
- Ottawa Heart Institute Research CorporationUniversity, hospital or other
- Collaborators
- Heart and Stroke Foundation of Ontario
- Study start
- Aug 2005
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 8 Nov 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- significantly increase total distance measured by an accelerometer and minutes of physical activity at a moderate intensity or higher,
- have significantly higher generic and heart-disease health-related quality of life, and
- 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.
Detailed 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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (24 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telephone-based physical activity counseling program | Behavioural | – |
Primary outcome
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+
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 outcomes measured at baseline and 6 and 12 months
8 secondary outcomes
Psychosocial and Environmental Mediators (questionnaire): psychosocial and environmental mediators of physical activity
Quality of Life (questionnaire): heart disease health-related quality of life
generic quality of life
secondary outcomes measured at baseline and 6 and 12 months
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)
the use of health care resources will be measured for medical event updates, patient related costs and work absenteeism
cost utility analysis to assess for cost per quality-adjusted life year (QALY)
measured at 3 (telephone), 6 (questionnaire), 9 (telephone) and 12 (questionnaire) months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2010.
- Background: PubMed 9838973Baranowski 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. doi: 10.1016/s0749-3797(98)00080-4.
- Background: PubMed 12370553Arthur 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. doi: 10.1097/00005768-200210000-00003.
- BackgroundDrummond M, O'Brien BJ, Stoddart G, Torrance G. Methodsfor the Economic Evaluation of Health Care Programmes:Oxford Medical Publications; 1997.
- Background: PubMed 12821592Thompson 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. doi: 10.1161/01.CIR.0000075572.40158.77. No abstract available.
- BackgroundCentres for Disease Control. Physical activity and health: Areport of the Surgeon General. Atlanta: National Centre forChronic Disease Prevention and Health Promotion; 1999.
- Background: PubMed 11420586Stone 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.
- Background: PubMed 3068205McLeroy KR, Bibeau D, Steckler A, Glanz K. An ecological perspective on health promotion programs. Health Educ Q. 1988 Winter;15(4):351-77. doi: 10.1177/109019818801500401.
- Background: PubMed 9421846Sallis 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. doi: 10.1080/02701367.1997.10608015.
- Background: PubMed 12133734King 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. doi: 10.1016/s0749-3797(02)00470-1.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Reid, PhD, MBA principal investigator
Ottawa Heart Institute Research Corporation
Louise Morrin, RPT, MBA study chair
Ottawa Heart Institute Research Corporation
Lyall Higginson, MD, FRCP(C) study chair
Ottawa Heart Institute Research Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Telephone-based physical activity counseling program in people with Coronary Arteriosclerosis and Myocardial Infarction, run by Ottawa Heart Institute Research Corporation at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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+. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00250913, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2010.