Angioplasty PatientsNCT00161603
Cornell Translational Behavioral Science Research Consortium: Angioplasty Qualitative Study
An observational study of Angioplasty Patients, run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
To explore and illuminate the cultural, social, and psychological factors that either facilitate or serve as barriers to behavioral change in angioplasty patients. Through a series of open-ended questions we will explore and build a better understanding of how culturally different patient groups perceive heart disease… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Angioplasty Patients
- What is being tested?
- Semi-structured, open-ended interviews
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2003to Sep 2003
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Post-angioplasty patients who had previously participated in an RCT designed to motivate multi-behavior change.
Who cannot join
- Patients who refuse to be interviewed, Patients who were not enrolled in the parent 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
To explore and illuminate the cultural, social, and psychological factors that either facilitate or serve as barriers to behavioral change in angioplasty patients. Through a series of open-ended questions we will explore and build a better understanding of how culturally different patient groups perceive heart disease and the difficulties in changing health behavior. In addition, we hope to better understand and anticipate barriers and issues that participants face in successfully changing their behaviors.
Read the detailed description
- To explore and illuminate the cultural, social, and psychological factors that either facilitate or serve as barriers to behavioral change in angioplasty patients. Through a series of open-ended questions we will explore and build a better understanding of how culturally different patient groups perceive heart disease and the difficulties in changing health behavior. In addition, we hope to better understand and anticipate barriers and issues that participants face in successfully changing their behaviors.
- To use the responses obtained in the qualitative interviews to inform how we should operationalize and tailor the positive affect induction and self-affirmation intervention methods in each of the populations under study. Specifically, this involves assessing what small gifts participants prefer to receive and what would be most effective in inducing positive affect.
- Conditions
- Angioplasty Patients
- Being tested
- Semi-structured, open-ended interviews
- Keywords
- Angioplasty, 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.
Semi-structured, open-ended interviewsBehavioural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startApr 2003
- Study completionSep 2003
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 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 18 participants
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Investigators
- Mary E Charlson, MD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00161603
- Sponsor's protocol ID
- N01-HC-25196 (0698-267)
- Other IDs
- N01HC25196
- Status last verified
- Apr 2008
- First submitted
- 8 Sep 2005
- Last updated
- 3 Apr 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Janey C. Peterson, RN, MA, Paul A. Pirraglia, MD, Sung Lee, MD, Laura Robbins, DSW, John P. Allegrante, PhD and Mary E. Charlson, MD. Living with heart disease: A qualitative study. Annals of Behavioral Medicine; 29(Supp), p. 28. April 14, 2005, Boston, MA.
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cornell Translational Behavioral Science Research Consortium: Angioplasty Qualitative Study
- ClinicalTrials.gov ID
- NCT00161603
- Acronym / sponsor ID
- N01-HC-25196 (0698-267)
- Conditions
- Angioplasty Patients
- Keywords
- Angioplasty, Behavior change, Physical activity, Risk reduction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Study start
- Apr 2003
- Study completion
- Sep 2003
- First posted
- 12 Sep 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.
To explore and illuminate the cultural, social, and psychological factors that either facilitate or serve as barriers to behavioral change in angioplasty patients. Through a series of open-ended questions we will explore and build a better understanding of how culturally different patient groups perceive heart disease and the difficulties in changing health behavior. In addition, we hope to better understand and anticipate barriers and issues that participants face in successfully changing their behaviors.
Detailed description
- To explore and illuminate the cultural, social, and psychological factors that either facilitate or serve as barriers to behavioral change in angioplasty patients. Through a series of open-ended questions we will explore and build a better understanding of how culturally different patient groups perceive heart disease and the difficulties in changing health behavior. In addition, we hope to better understand and anticipate barriers and issues that participants face in successfully changing their behaviors.
- To use the responses obtained in the qualitative interviews to inform how we should operationalize and tailor the positive affect induction and self-affirmation intervention methods in each of the populations under study. Specifically, this involves assessing what small gifts participants prefer to receive and what would be most effective in inducing positive affect.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Post-angioplasty patients who had previously participated in an RCT designed to motivate multi-behavior change.
Key exclusion criteria (1 listed)
- Patients who refuse to be interviewed, Patients who were not enrolled in the parent 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 |
|---|---|---|
| Semi-structured, open-ended interviews | Behavioural | – |
Primary outcome
Not reported in the source record.
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 3 Apr 2008.
- Results publicationJaney C. Peterson, RN, MA, Paul A. Pirraglia, MD, Sung Lee, MD, Laura Robbins, DSW, John P. Allegrante, PhD and Mary E. Charlson, MD. Living with heart disease: A qualitative study. Annals of Behavioral Medicine; 29(Supp), p. 28. April 14, 2005, Boston, MA.
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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?
An observational study of 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 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 3 Apr 2008. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00161603, 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 3 Apr 2008.