PainNCT01469780
Assessing Pain as a Mediator of Behavior Change in Post-coronary Angioplasty Patients
An observational study of Pain and Depressive Symptoms, run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
The focus of this secondary data analysis is to determine whether pain due to a combination of both cardiac and non cardiac sources operates as a mediator of behavior change, an area that has not been previously evaluated. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Depressive Symptoms, Quality of Life
- How many people
- 660 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 1999to Feb 2005
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The is a database study of a cohort of 660 patients with cardiovascular disease who had recently undergone coronary angioplasty.
Who may be able to join
- all patients in the database who had participated in the Healthy Behavior Trial. The Healthy Behavior Trial was a randomized controlled trial of a psychoeducational intervention designed to motivate multi-behavior change (changing 2 or more cardiovascular risk factors) in post-coronary angioplasty patients over the course of 24 months.
Who cannot join
- Non-participants in the Healthy Behavior Trial
Trial locations and contacts
1 site in 1 country.
United States1 site
Weill Cornell Medical College
New York, New York, 10065
About this study
The focus of this secondary data analysis is to determine whether pain due to a combination of both cardiac and non cardiac sources operates as a mediator of behavior change, an area that has not been previously evaluated.
Read the detailed description
This is a secondary data analysis of an existing dataset generated from The Healthy Behavior Trial, an NHLBI-funded randomized controlled trial that enrolled 660 post-coronary angioplasty patients between October 1999 and March 2001. This study employed a behavioral intervention to motivate PCI patients to adopt health behaviors in order to reduce major cardiac and neurologic morbidity and mortality. Patients in the experimental arm were told their estimated biologic age (calculated from the health risk assessment) and risk factors were presented in terms of "biologic age reduction" that could be achieved if a change was made in each health behavior area. Those in the control arm were provided with risk factors (also obtained from the health risk assessment) and told that changing each health behavior could "increase your lifespan."
Specific Aims:
Utilizing 12 month longitudinal data for patients with cardiovascular disease who have undergone coronary angioplasty we will:
Specific aim 1: Determine if pain is a mediator of health behavior change over 12 months.
Specific aim 2: Assess behavior change patterns over 12 months, stratifying for degree of pain, depression and/or stress.
Specific aim 3: Evaluate the effect of pain on quality of life (physical, social, role-physical, role-emotional, vitality, mental health, bodily pain and general health domains), combined major cardiac and neurologic morbidity/mortality and hospitalizations over 12 months.
- Conditions
- Pain, Depressive Symptoms, Quality of Life
- Keywords
- Pain, Health behavior change, Coronary angioplasty, Cardiovascular disease, Outcomes, Morbidity, Mortality
- Medical subject headings
- Pain, Depression, Cardiovascular Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
successful behavior change over 12 months
Health behavior will be examined in five areas: overall physical activity, strength training, aerobic activity, weight loss, and smoking cessation. Successful health behavior change will be defined as "action" (engaging in the behavior < six months) or "maintenance" (engaging in the behavior ≥ six months to five years), according to the Transtheoretical Model. We will use self-reported data.
Measured: Baseline, 3, 6, 9 and 12 months
Secondary outcomes (1)
Quality of life
The SF-36 health survey will be the primary measure of quality of life. Each of the eight individual domain scores will be evaluated (physical, social, role-physical, role-emotional, vitality, mental health, bodily pain and general health) and the within-patient change from baseline to 12 months will be calculated. The physical and mental component summary measures will also be calculated, as will the within-patient change from baseline to 12 months for the component scores. We will assess these measures as both continuous and dichotomous measures.
Measured: Within-patient change from baseline to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2011 (estimated)
- Study startApr 1999
- Primary completionAug 2003
- Study completionFeb 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PainStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 660 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Janey C Peterson, EdD, MS, RN, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01469780
- Sponsor's protocol ID
- 9806003392
- Other IDs
- 3P30AG022845-07S1
- Status last verified
- Mar 2012
- First submitted
- 8 Nov 2011
- Last updated
- 8 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Charlson ME, Peterson JC, Boutin-Foster C, Briggs WM, Ogedegbe GG, McCulloch CE, Hollenberg J, Wong C, Allegrante JP. Changing health behaviors to improve health outcomes after angioplasty: a randomized trial of net present value versus future value risk communication. Health Educ Res. 2008 Oct;23(5):826-39. doi: 10.1093/her/cym068. Epub 2007 Nov 19.
PubMed 18025064
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Pain as a Mediator of Behavior Change in Post-coronary Angioplasty Patients
- ClinicalTrials.gov ID
- NCT01469780
- Acronym / sponsor ID
- 9806003392
- Conditions
- Pain, Depressive Symptoms, Quality of Life
- Keywords
- Pain, Health behavior change, Coronary angioplasty, Cardiovascular disease, Outcomes, Morbidity, Mortality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 660 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- Apr 1999
- Primary completion
- Aug 2003 (actual)
- Study completion
- Feb 2005 (actual)
- First posted
- 10 Nov 2011 (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 focus of this secondary data analysis is to determine whether pain due to a combination of both cardiac and non cardiac sources operates as a mediator of behavior change, an area that has not been previously evaluated.
Detailed description
This is a secondary data analysis of an existing dataset generated from The Healthy Behavior Trial, an NHLBI-funded randomized controlled trial that enrolled 660 post-coronary angioplasty patients between October 1999 and March 2001. This study employed a behavioral intervention to motivate PCI patients to adopt health behaviors in order to reduce major cardiac and neurologic morbidity and mortality. Patients in the experimental arm were told their estimated biologic age (calculated from the health risk assessment) and risk factors were presented in terms of "biologic age reduction" that could be achieved if a change was made in each health behavior area. Those in the control arm were provided with risk factors (also obtained from the health risk assessment) and told that changing each health behavior could "increase your lifespan."
Specific Aims:
Utilizing 12 month longitudinal data for patients with cardiovascular disease who have undergone coronary angioplasty we will:
Specific aim 1: Determine if pain is a mediator of health behavior change over 12 months.
Specific aim 2: Assess behavior change patterns over 12 months, stratifying for degree of pain, depression and/or stress.
Specific aim 3: Evaluate the effect of pain on quality of life (physical, social, role-physical, role-emotional, vitality, mental health, bodily pain and general health domains), combined major cardiac and neurologic morbidity/mortality and hospitalizations over 12 months.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The is a database study of a cohort of 660 patients with cardiovascular disease who had recently undergone coronary angioplasty.
Key inclusion criteria (1 listed)
- all patients in the database who had participated in the Healthy Behavior Trial. The Healthy Behavior Trial was a randomized controlled trial of a psychoeducational intervention designed to motivate multi-behavior change (changing 2 or more cardiovascular risk factors) in post-coronary angioplasty patients over the course of 24 months.
Key exclusion criteria (1 listed)
- Non-participants in the Healthy Behavior Trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
successful behavior change over 12 months
Time frame: Baseline, 3, 6, 9 and 12 months
Health behavior will be examined in five areas: overall physical activity, strength training, aerobic activity, weight loss, and smoking cessation. Successful health behavior change will be defined as "action" (engaging in the behavior < six months) or "maintenance" (engaging in the behavior ≥ six months to five years), according to the Transtheoretical Model. We will use self-reported data.
1 secondary outcome
Quality of life
Time frame: Within-patient change from baseline to 12 months
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 8 Mar 2012.
- Background: PubMed 18025064Charlson ME, Peterson JC, Boutin-Foster C, Briggs WM, Ogedegbe GG, McCulloch CE, Hollenberg J, Wong C, Allegrante JP. Changing health behaviors to improve health outcomes after angioplasty: a randomized trial of net present value versus future value risk communication. Health Educ Res. 2008 Oct;23(5):826-39. doi: 10.1093/her/cym068. Epub 2007 Nov 19.
- Related InfoLink provided by the sponsor.
Related trials for Pain
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
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.
Janey C Peterson, EdD, MS, RN 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?
An observational study of Pain and Depressive Symptoms, 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 1 inclusion and 1 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 8 Mar 2012. 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?
successful behavior change over 12 months (time frame: Baseline, 3, 6, 9 and 12 months). 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 NCT01469780, which also lists 1 linked publication.
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 8 Mar 2012.