Angioplasty PatientsNCT00248846
A Randomized Trial: Changing Behavior in Post-Angioplasty Patients
A study testing Intervention Group in people with Angioplasty Patients, run by Weill Medical College of Cornell University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 110 years
- Conditions the study is for
- Angioplasty Patients
- What is being tested?
- Intervention Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 242 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2004to Jul 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 110 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
The New York Presbyterian Hospital-Weill Medical Center
New York, New York, 10021
About this study
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.
Read the 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.
- Conditions
- Angioplasty Patients
- Being tested
- Intervention Group
- Keywords
- Angioplasty patients, Behavior change, Physical activity, Risk reduction
- Medical subject headings
- Motor Activity, Risk Reduction Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention GroupBehavioural
Also called Postivie affect and self-affirmation induction vs. control
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Intervention Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Within patient change in the Paffenbarger Exercise and Physical Activity Index
Measured: basline, at 2-month intervals(2, 4, 6, 8, 10-months) and closeout
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2005 (estimated)
- Study startOct 2004
- Primary completionJan 2008
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Angioplasty PatientsStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 242 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mary E. Charlson, MD, Weill Medical College of Cornell University
- Investigators
- Mary E Charlson, MD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00248846
- Sponsor's protocol ID
- N01-HC-25196 (0203-694)
- Other IDs
- N01HC25196
- Status last verified
- Feb 2017
- First submitted
- 3 Nov 2005
- Last updated
- 23 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: No Plan to Share IPD
Publications
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.
PubMed 20207270Charlson 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.
PubMed 17459784Peterson 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.
PubMed 22269589Peterson 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.
PubMed 25456561
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial: Changing Behavior in Post-Angioplasty Patients
- ClinicalTrials.gov ID
- NCT00248846
- Acronym / sponsor ID
- N01-HC-25196 (0203-694)
- Conditions
- Angioplasty Patients
- Keywords
- Angioplasty patients, Behavior change, Physical activity, Risk reduction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 242 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Study start
- Oct 2004 (actual)
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 4 Nov 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Intervention GroupThis 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. |
Who may qualify
- Ages
- 18 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention GroupAlso: Postivie affect and self-affirmation induction vs. controlDuring 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. | Behavioural | Intervention Group |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2017.
- Background: PubMed 20207270Peterson 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.
- Background: PubMed 17459784Charlson 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.
- Results publication: PubMed 22269589Peterson 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.
- Derived from this study: PubMed 25456561Peterson 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.
- Individual participant dataSharing planned: No. No Plan to Share IPD
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mary E Charlson, MD principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention Group in people with Angioplasty Patients, run by Weill Medical College of Cornell University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00248846, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2017.