The Efficacy and Cost-Effectiveness of Behavioral Counseling for Exercise in Men and Women Following Acute Myocardial Infarction (AMI) and Percutaneous Coronary Intervention (PCI)
2010年11月5日 更新者：Ottawa Heart Institute Research Corporation
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:
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.
調査の概要
詳細な説明
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.
研究の種類
介入
入学 (予想される)
304
段階
- フェーズ 1
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Ontario
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Ottawa、Ontario、カナダ、K1Y 4W7
- University of Ottawa Heart Institute
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
20年～85年 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
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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+
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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
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Primary outcomes measured at baseline and 6 and 12 months
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二次結果の測定
結果測定 |
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Psychosocial and Environmental Mediators (questionnaire): psychosocial and environmental mediators of physical activity
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Quality of Life (questionnaire): heart disease health-related quality of life
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generic quality of life
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secondary outcomes measured at baseline and 6 and 12 months
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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)
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the use of health care resources will be measured for medical event updates, patient related costs and work absenteeism
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cost utility analysis to assess for cost per quality-adjusted life year (QALY)
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measured at 3 (telephone), 6 (questionnaire), 9 (telephone) and 12 (questionnaire) months
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Robert Reid, PhD, MBA、Ottawa Heart Institute Research Corporation
- スタディチェア：Louise Morrin, RPT, MBA、Ottawa Heart Institute Research Corporation
- スタディチェア：Lyall Higginson, MD, FRCP(C)、Ottawa Heart Institute Research Corporation
- スタディチェア：Andrew Pipe, MD、The University of Ottawa Heart Institute
- スタディチェア：Andreas Wielgosz, MD, FRCP(C)、The Ottawa General Hospital - Department of Cadiology - General Campus
- スタディチェア：Neil Oldridge, PhD、College of Health Sciences, University of Wisconsin-Milwaukee
- スタディチェア：George Wells, PhD、Clinical Epidemiology Unit, University of Ottawa Heart Institute
- スタディチェア：Chris Blanchard, PhD、Department of Human Kinetics, University of Ottawa & University of Ottawa Heart Institute
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- 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. Erratum In: Am J Prev Med 1999 Jul;17(1):98.
- 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. doi: 10.1016/s0749-3797(02)00470-1.
- McLeroy 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.
- 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. doi: 10.1080/02701367.1997.10608015.
- 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.
- 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. doi: 10.1097/00005768-200210000-00003.
- Drummond M, O'Brien BJ, Stoddart G, Torrance G. Methodsfor the Economic Evaluation of Health Care Programmes:Oxford Medical Publications; 1997.
- Centres 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.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2005年8月1日
一次修了 (実際)
2009年12月1日
研究の完了 (実際)
2009年12月1日
試験登録日
最初に提出
2005年11月7日
QC基準を満たした最初の提出物
2005年11月7日
最初の投稿 (見積もり)
2005年11月8日
学習記録の更新
投稿された最後の更新 (見積もり)
2010年11月9日
QC基準を満たした最後の更新が送信されました
2010年11月5日
最終確認日
2010年11月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。