A Randomized Trial: Changing Behavior in Post-Angioplasty Patients
|ClinicalTrials.gov Identifier: NCT00248846|
Recruitment Status : Completed
First Posted : November 4, 2005
Last Update Posted : February 23, 2017
|Condition or disease||Intervention/treatment|
|Angioplasty Patients||Behavioral: Intervention Group|
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.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||242 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A Randomized Trial: Changing Behavior in Post-Angioplasty Patients|
|Actual Study Start Date :||October 2004|
|Primary Completion Date :||January 2008|
|Study Completion Date :||July 2011|
No Intervention: Control Group
This group received follow-up every 2-months for one year. Follow-up included questions about their heart disease progression and how well they had been able to engage in their doctor approved physical activity goal.
Experimental: Intervention Group
This group received follow-up every 2-months for one year. Follow-up included questions about their heart disease progression and how well they had been able to engage in their doctor approved physical activity goal, which was the same as the control arm. Additionally, subjects in this arm were encouraged to use positive affect and self-affirmation techniques to motivate an increased level of participation in their physical activity goal. These subjects also received small token gifts to remind them of their study participation.
Behavioral: Intervention Group
During the physical activity goal setting process, subjects were randomly assigned to either the control or the intervention group. The intervention included receiving an additional educational workbook about using positive affect and self affirmation, as well as participating in using positive affect and self-affirmation to motivate behavior change, which in this case was to increase their physical activity level. Patient also received small token gifts to remind them of their participation in the study and to induce positive affect. The control group also set a physical activity goal and received the same follow-up, but did not participate in the positive affect and self-affirmation portion.
Other Name: Postivie affect and self-affirmation induction vs. control
- Within patient change in the Paffenbarger Exercise and Physical Activity Index [ Time Frame: basline, at 2-month intervals(2, 4, 6, 8, 10-months) and closeout ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00248846
|United States, New York|
|The New York Presbyterian Hospital-Weill Medical Center|
|New York, New York, United States, 10021|
|Principal Investigator:||Mary E Charlson, MD||Weill Medical College of Cornell University|