Acute Coronary SyndromePEACEIIaNCT02298296
Trajectory of Positive Psychological States in Patients With ACS
An observational study of Acute Coronary Syndrome, run by Massachusetts General Hospital.
Trial summary
The purpose of the study is to to determine the natural history of positive psychological states, health status, and functioning, over an 8 week period following admission for an acute coronary syndrome (ACS). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- Jun 2014to Dec 2014
- 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: Subjects were recruited from inpatient cardiac units in a large, urban hospital.
Who may be able to join
- Suboptimal adherence to health behaviors. This will be defined as mean item score of <15 (suboptimal) on three Medical Outcomes Study-Specific Adherence Scale (MOS SAS) items.
- Submaximal self-reported optimism. This will be defined as a total score of <30 on the Life Orientation Test-Revised (LOT-R) .
- Submaximal self-reported positive affect. This will be defined as a total score of <50 on the Positive and Negative Affect Schedule (PANAS) .
Who cannot join
- Cognitive deficits, assessed via a 6-item cognitive screen used to assess appropriate participation of medically-ill patients in research studies.
- Medical conditions precluding interviews or likely to lead to death within 6 months, determined in consultation with the primary treatment team and cardiology co-investigator Dr. Januzzi.
- Inability to communicate in English.
- Inability to participate in physical activity.
About this study
Official title: Trajectory of Positive Psychological States in Patients With Acute Coronary Syndrome
The purpose of the study is to to determine the natural history of positive psychological states, health status, and functioning, over an 8 week period following admission for an acute coronary syndrome (ACS). We aim to compare the changes in these factors from baseline to 8-week follow-up with corresponding changes in the completed proof-of-concept intervention trial (NCT02004158).
- Conditions
- Acute Coronary Syndrome
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| No treatment | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in positive affect measured by self-report questionnaires
To determine the change in positive psychological states, specifically optimism and positive affect, over an 8 week period following admission for ACS as measured by the Life Orientation Questionnaire (LOT-R [trait optimism]), Life Orientation Questionnaire-State (LOT-RS [state optimism]), and the Positive and Negative Affect Schedule (PANAS [positive affect]).
Measured: Baseline, 8 weeks
Secondary outcomes (2)
Change in behavior adherence measured by a self-report questionnaire
To assess changes in health behavior adherence over an 8 week period following admission for ACS using the Medical Outcomes Study-Specific Adherence Scale (MOS-SAS items on physical activity, diet, and medication).
Measured: Baseline, 8 weeks
Change in function measured by self-report questionnaires
To assess changes in functional status over an 8 week period following admission for ACS using the Women's Ischemia Syndrome Evaluation (WISE [functional status]) and the Short Form health survey (SF-12 [health-related quality of life]).
Measured: Baseline, 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2014 (estimated)
- Study startJun 2014
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Jeff C. Huffman, MD, Massachusetts General Hospital
- Investigators
- Jeff C Huffman, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02298296
- Sponsor's protocol ID
- 2014P000945
- Acronym
- PEACEIIa
- Status last verified
- Apr 2016
- First submitted
- 3 Nov 2014
- Last updated
- 19 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trajectory of Positive Psychological States in Patients With Acute Coronary Syndrome
- ClinicalTrials.gov ID
- NCT02298296
- Acronym / sponsor ID
- PEACEIIa / 2014P000945
- Conditions
- Acute Coronary Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Jun 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 21 Nov 2014 (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 purpose of the study is to to determine the natural history of positive psychological states, health status, and functioning, over an 8 week period following admission for an acute coronary syndrome (ACS). We aim to compare the changes in these factors from baseline to 8-week follow-up with corresponding changes in the completed proof-of-concept intervention trial (NCT02004158).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| No treatment | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects were recruited from inpatient cardiac units in a large, urban hospital.
Key inclusion criteria (3 listed)
- Suboptimal adherence to health behaviors. This will be defined as mean item score of <15 (suboptimal) on three Medical Outcomes Study-Specific Adherence Scale (MOS SAS) items.
- Submaximal self-reported optimism. This will be defined as a total score of <30 on the Life Orientation Test-Revised (LOT-R) .
- Submaximal self-reported positive affect. This will be defined as a total score of <50 on the Positive and Negative Affect Schedule (PANAS) .
Key exclusion criteria (4 listed)
- Cognitive deficits, assessed via a 6-item cognitive screen used to assess appropriate participation of medically-ill patients in research studies.
- Medical conditions precluding interviews or likely to lead to death within 6 months, determined in consultation with the primary treatment team and cardiology co-investigator Dr. Januzzi.
- Inability to communicate in English.
- Inability to participate in physical activity.
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
Change in positive affect measured by self-report questionnaires
Time frame: Baseline, 8 weeks
To determine the change in positive psychological states, specifically optimism and positive affect, over an 8 week period following admission for ACS as measured by the Life Orientation Questionnaire (LOT-R [trait optimism]), Life Orientation Questionnaire-State (LOT-RS [state optimism]), and the Positive and Negative Affect Schedule (PANAS [positive affect]).
2 secondary outcomes
Change in behavior adherence measured by a self-report questionnaire
Time frame: Baseline, 8 weeks
Change in function measured by self-report questionnaires
Time frame: Baseline, 8 weeks
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 19 Apr 2016.
- Individual participant dataSharing planned: No
Related trials for Acute Coronary Syndrome
Recruiting
CT Stress Myocardial Perfusion, Fractional Flow Reserve and Angiography in Patients With Stable Chest Pain Syndromes
Coronary Artery Disease, Chest Syndrome
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
RecruitingPhase 4
Early Single Antiplatelet Therapy After IVUS-Guided PCI in Acute Coronary Syndrome
Acute Coronary Syndromes, STEMI
Recruiting
AI-Assisted Interpretation of Cardiac CT in the Emergency Department
Chest Pain, Acute Coronary Syndrome
Enrolling by invitation
Optical Coherence Tomography in Acute Vessel Evaluation
Ischemic Heart Disease, Ischemic Coronary Artery Disease
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.
Jeff C Huffman, MD principal investigator
Massachusetts General Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Coronary Syndrome, run by Massachusetts General Hospital.
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 3 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 19 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Change in positive affect measured by self-report questionnaires (time frame: Baseline, 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Apr 2016.