NCT00250913

Brief 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:

  • 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
304

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Aug 2005

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 7, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 8, 2005

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

November 9, 2010

Status Verified

November 1, 2010

Enrollment Period

4.3 years

First QC Date

November 7, 2005

Last Update Submit

November 5, 2010

Conditions

Coronary ArteriosclerosisMyocardial Infarction

Keywords

motor activitydeterminantspsychologyhealth care costsquality of lifeAngioplasty

Outcome Measures

Primary Outcomes (3)

  • 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)

  • +3 more secondary outcomes

Interventions

Telephone-based physical activity counseling programBEHAVIORAL

Eligibility Criteria

Age20 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Cardiac Diagnosis:
  • \) 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

You may not qualify if:

  • 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
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Ottawa Heart Institute

Ottawa, Ontario, K1Y 4W7, Canada

Location

Related Publications (9)

  • 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.

    PMID: 9838973BACKGROUND

  • 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.

    PMID: 12370553BACKGROUND

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

    BACKGROUND

  • 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.

    PMID: 12821592BACKGROUND

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

    BACKGROUND

  • 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.

    PMID: 11420586BACKGROUND

  • 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.

    PMID: 3068205BACKGROUND

  • 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.

    PMID: 9421846BACKGROUND

  • 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.

    PMID: 12133734BACKGROUND

MeSH Terms

Conditions

Coronary Artery DiseaseMyocardial InfarctionMotor Activity

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisBehavior

Study Officials

  • Robert Reid, PhD, MBA

    Ottawa Heart Institute Research Corporation

    PRINCIPAL INVESTIGATOR

  • Louise Morrin, RPT, MBA

    Ottawa Heart Institute Research Corporation

    STUDY CHAIR

  • Lyall Higginson, MD, FRCP(C)

    Ottawa Heart Institute Research Corporation

    STUDY CHAIR

  • Andrew Pipe, MD

    The University of Ottawa Heart Institute

    STUDY CHAIR

  • Andreas Wielgosz, MD, FRCP(C)

    The Ottawa General Hospital - Department of Cadiology - General Campus

    STUDY CHAIR

  • Neil Oldridge, PhD

    College of Health Sciences, University of Wisconsin-Milwaukee

    STUDY CHAIR

  • George Wells, PhD

    Clinical Epidemiology Unit, University of Ottawa Heart Institute

    STUDY CHAIR

  • Chris Blanchard, PhD

    Department of Human Kinetics, University of Ottawa & University of Ottawa Heart Institute

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 7, 2005

First Posted

November 8, 2005

Study Start

August 1, 2005

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

November 9, 2010

Record last verified: 2010-11

Locations

CA(1)