Clinical trial NCT00248846: A Randomized Trial: Changing Behavior in Post-Angioplasty Patients
Official title: A Randomized Trial: Changing Behavior in Post-Angioplasty Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Angioplasty Patients
Keywords: Angioplasty patients
Behavior change
Physical activity
Risk reduction
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
First posted: 2005-11-04
Enrollment: 242
Sex: ALL
Minimum age (years): 18
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The long-term objective of this study is to determine whether a positive affect and self-affirmation condition added to an empirically demonstrated approach for motivating behavior change is more effective than a standard approach in reducing risk factor behavior among a high-risk group of patients with coronary artery disease. Thus, the goal of the project is to refine and improve strategies for long-term maintenance of physical activity among patients post-angioplasty or stent.

Detailed description: Among coronary artery disease patients who have just had either angioplasty or stents, the objective of this randomized trial is to evaluate whether a novel behavioral intervention that employs induced positive affect and self-affirmation is more effective than an intervention without positive affect in increasing the maintenance of newly initiated physical activity post-procedure.

Secondary objectives:

* To determine whether more patients who receive the positive affect and self-affirmation intervention initiate more multiple behavior changes (e.g., changes in more health behaviors directed to their risk-factor profile) than those in the control group at one year.
* To determine whether the positive affect and self-affirmation intervention increases physical activity among patients who have depressive symptoms.
* To determine whether patients who are successful in increasing physical activity are more successful at changing other health behaviors.

Eligibility criteria: Inclusion Criteria:

* All patients undergoing coronary artery catheterization who are found to have at least single vessel stenosis and who have had revascularization with angioplasty or coronary artery stenting will be eligible for enrollment.
* Patients must be able to provide informed consent within the one week after the procedure.

Exclusion Criteria:

* Patients who are unable to walk several blocks regardless of the reason will be excluded from all the trials (e.g., arthritis, stroke, claudication).
* Enrollment in other trials designed to modify post-procedure behaviors.
* Patients who refuse to participate will be excluded.
* If at any time prior to enrollment in the study, the patient's cardiologist determines that the patient should not participate in this study, the patient will not be enrolled in the trial.

Primary outcomes:
measure: Within patient change in the Paffenbarger Exercise and Physical Activity Index
timeFrame: basline, at 2-month intervals(2, 4, 6, 8, 10-months) and closeout
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: The New York Presbyterian Hospital-Weill Medical Center
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Mary E Charlson, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Peterson JC, Allegrante JP, Pirraglia PA, Robbins L, Lane KP, Boschert KA, Charlson ME. Living with heart disease after angioplasty: A qualitative study of patients who have been successful or unsuccessful in multiple behavior change. Heart Lung. 2010 Mar-Apr;39(2):105-15. doi: 10.1016/j.hrtlng.2009.06.017. Epub 2009 Aug 25.
citation: Charlson ME, Boutin-Foster C, Mancuso CA, Peterson JC, Ogedegbe G, Briggs WM, Robbins L, Isen AM, Allegrante JP; Translational Behavioral Science Research Consortium. Randomized controlled trials of positive affect and self-affirmation to facilitate healthy behaviors in patients with cardiopulmonary diseases: rationale, trial design, and methods. Contemp Clin Trials. 2007 Nov;28(6):748-62. doi: 10.1016/j.cct.2007.03.002. Epub 2007 Mar 12.
citation: Peterson JC, Charlson ME, Hoffman Z, Wells MT, Wong SC, Hollenberg JP, Jobe JB, Boschert KA, Isen AM, Allegrante JP. A randomized controlled trial of positive-affect induction to promote physical activity after percutaneous coronary intervention. Arch Intern Med. 2012 Feb 27;172(4):329-36. doi: 10.1001/archinternmed.2011.1311. Epub 2012 Jan 23.
citation: Peterson JC, Charlson ME, Wells MT, Altemus M. Depression, coronary artery disease, and physical activity: how much exercise is enough? Clin Ther. 2014 Nov 1;36(11):1518-30. doi: 10.1016/j.clinthera.2014.10.003. Epub 2014 Nov 14.