A Randomized Trial: Changing Behavior in Post-Angioplasty Patients

NCT00248846 | Completed DMC

• 2 other identifiers: N01-HC-25196 (0203-694)N01HC25196
• Study Type: interventional
• Target: 242
• Locations: 1 country
• Sites: 1

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.

Conditions

Angioplasty Patients

Keywords

Angioplasty patients; Behavior change; Physical activity; Risk reduction

Outcome Measures

Primary Outcomes (1)

• Within patient change in the Paffenbarger Exercise and Physical Activity Index

  basline, at 2-month intervals(2, 4, 6, 8, 10-months) and closeout

Study Arms (2)

Control Group

NO INTERVENTION

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.

Intervention Group

EXPERIMENTAL

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

Interventions

Intervention Group BEHAVIORAL

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.

Also known as: Postivie affect and self-affirmation induction vs. control

Intervention Group

Eligibility Criteria

• Age: 18 Years - 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead

Study Sites (1)

The New York Presbyterian Hospital-Weill Medical Center

New York, New York, 10021, United States

Location

Related Publications (4)

• 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.

  PMID: 20207270 BACKGROUND

• 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.

  PMID: 17459784 BACKGROUND

• 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.

  PMID: 22269589 RESULT

• 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.

  PMID: 25456561 DERIVED

MeSH Terms

Conditions

Motor Activity; Risk Reduction Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Mary E Charlson, MD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 3, 2005
• First Posted: November 4, 2005
• Study Start: October 1, 2004
• Primary Completion: January 1, 2008
• Study Completion: July 1, 2011
• Last Updated: February 23, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)