Acute Coronary SyndromePEACENCT01807442
Positive Psychology to Improve Cardiac Health Behaviors
A study testing Qualitative Interview and Adherence in people with Acute Coronary Syndrome and Emotions, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The purpose of the study is to understand peoples' positive emotions, like how optimistic or grateful they feel, after they have had a heart problem. The investigators want to determine whether positive emotions affect peoples' ability to follow recommendations, like following a healthy diet, exercising, and taking… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome, Emotions, Patient Compliance
- What is being tested?
- Qualitative Interview and Adherence
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2013to Dec 2013
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Admission to Massachusetts General Hospital cardiac floors (Ellison 9, 10, 11)
- Age 18 or older
- Admitted with myocardial infarction or unstable angina
- Score of less than 15 --OR-- greater than or equal to 15 on the adherence scale
- Ability to read and write in English
Who cannot join
- Cognitive deficits as assessed by a 6-item screen
- Medical conditions that prevent interviewing or are likely to lead to death within 6 months
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Developing a Positive Psychology Intervention to Improve Cardiac Health Behaviors: Qualitative Research Phase
The purpose of the study is to understand peoples' positive emotions, like how optimistic or grateful they feel, after they have had a heart problem. The investigators want to determine whether positive emotions affect peoples' ability to follow recommendations, like following a healthy diet, exercising, and taking medication.
Read the detailed description
The investigators aim to develop a novel positive psychology intervention that is adapted for patients hospitalized for an acute coronary syndrome (ACS). A treatment cultivating positive emotions in this vulnerable population could provide broad and significant health benefits, and may have distinct-and more powerful-effects than simply attempting to dampen negative emotions.
In this study, the investigators will use mixed methods (qualitative and quantitative) to take the first step towards developing such a treatment, with a major focus on the qualitative aspects of the patient assessments/interviews.
In this project, the investigators hope to do the following:
- Identify, through qualitative research, deficits in positive emotional and cognitive states prior to, during, and after cardiac admission: What positive emotions are lacking in hospitalized ACS patients?
- Explore strategies to enhance positive emotional and cognitive states in ACS patients.
- Identify links between these positive states and health behavior (diet, physical activity, and medication).
- Identify other barriers to compliance with health behaviors. What other factors adversely influence compliance with health behaviors in this population?
- Use quantitative measures of positive affect to ensure that the investigators are adequately capturing information about optimism and other positive states
- Develop a preliminary positive psychology-based intervention using the above information
- Explore the feasibility of using methods to objectively measure aspirin adherence and physical activity in this population.
To accomplish these goals, the investigators will interview 30 ACS patients during admission to the inpatient cardiac unit and 12 weeks after discharge. The investigators will identify 15 patients who demonstrate suboptimal adherence as reported by the Medical Outcomes Study Specific Adherence Scale (MOS-SAS) and 15 patients who demonstrate good adherence to health-related behaviors.
For these interviews, the investigators will first ask about positive emotional states that patients have experienced. the investigators will then inquire about potential ideas for increasing these positive emotional states by asking patients what has worked for them in the past and what they have noticed seems to work for others. The investigators will also describe some positive psychology exercises to the patients and ask whether they think those exercises would be effective at increasing positive emotional states. Next, the investigators will ask about health behaviors in which the patient has engaged. The investigators will explore the relationship between these behaviors and positive emotional states. Finally, the investigators will explore with patients some barriers to completing health behaviors and solicit suggestions for overcoming or mitigating these barriers.
- Conditions
- Acute Coronary Syndrome, Emotions, Patient Compliance
- Being tested
- Qualitative Interview and Adherence
- Keywords
- Acute Coronary Syndrome, Positive Psychology, Adherence to Health Behaviors
- Medical subject headings
- Acute Coronary Syndrome, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Qualitative Interview and AdherenceOther
All participants receive the same intervention. The intervention involves two qualitative interviews per participant. The first interview occurs in the hospital, and the second interview occurs at 12 weeks. Participants also receive a pill bottle that tracks when they take their aspirin. They will also receive a step counter to use for two weeks at the end of the study.
| Study group | Role | What they receive |
|---|---|---|
| Optimal adherence | Other | Participants receive the qualitative interview and adherence intervention.
This arm includes participants with scores of greater than or equal to 15 on the Medical Outcomes Study Specific Adherence Scale. This scale ranges from a score of 3 (extremely low adherence to health behaviors) to a score of 18 (extremely high adherence to health behaviors). A score of greater than or equal to 15 suggests optimal adherence to health behaviors. Receives: Other: Qualitative Interview and Adherence |
| Sub-optimal adherence | Other | Participants receive the qualitative interview and adherence intervention.
This arm includes participants with scores of less than 15 on the Medical Outcomes Study Specific Adherence Scale. This scale ranges from a score of 3 (extremely low adherence to health behaviors) to a score of 18 (extremely high adherence to health behaviors). A score of less than 15 suggests sub-optimal adherence to health behaviors. Receives: Other: Qualitative Interview and Adherence |
What is being measured
The primary outcome is the main question the study is designed to answer.
Deficits in positive affect
Qualitative data:
The investigators will extract information from 2 quantitative interviews to learn about participants' deficits in positive affect.
Quantitative data:
Life Orientation Test-Revised, Positive And Negative Affect Scale, Hospital Anxiety and Depression Scale.
Measured: 12 weeks
Barriers to health behaviors
Qualitative data:
The investigators will extract information from 2 qualitative interviews to learn about participants' barriers to completing health behaviors.
Quantitative data:
Participants will receive a pill bottle that tracks when they take their aspirin. Participants will also receive a step counter to wear for two weeks.
Measured: 12 weeks
Secondary outcomes (1)
Changes in positive affect
Qualitative data:
The investigators will compare information from the 2 qualitative interviews to learn about participants' changes in positive affect.
Measured: Change from baseline positive affect at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2013 (estimated)
- Study startMar 2013
- Primary completionAug 2013
- Study completionDec 2013
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 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
- NCT01807442
- Sponsor's protocol ID
- 2011P002729
- Other IDs
- 1R01HL113272-01A1
- Acronym
- PEACE
- Status last verified
- Sep 2014
- First submitted
- 4 Mar 2013
- Last updated
- 16 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing a Positive Psychology Intervention to Improve Cardiac Health Behaviors: Qualitative Research Phase
- ClinicalTrials.gov ID
- NCT01807442
- Acronym / sponsor ID
- PEACE / 2011P002729
- Conditions
- Acute Coronary Syndrome, Emotions, Patient Compliance
- Keywords
- Acute Coronary Syndrome, Positive Psychology, Adherence to Health Behaviors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Mar 2013
- Primary completion
- Aug 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 8 Mar 2013 (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 understand peoples' positive emotions, like how optimistic or grateful they feel, after they have had a heart problem. The investigators want to determine whether positive emotions affect peoples' ability to follow recommendations, like following a healthy diet, exercising, and taking medication.
Detailed description
The investigators aim to develop a novel positive psychology intervention that is adapted for patients hospitalized for an acute coronary syndrome (ACS). A treatment cultivating positive emotions in this vulnerable population could provide broad and significant health benefits, and may have distinct-and more powerful-effects than simply attempting to dampen negative emotions.
In this study, the investigators will use mixed methods (qualitative and quantitative) to take the first step towards developing such a treatment, with a major focus on the qualitative aspects of the patient assessments/interviews.
In this project, the investigators hope to do the following:
- Identify, through qualitative research, deficits in positive emotional and cognitive states prior to, during, and after cardiac admission: What positive emotions are lacking in hospitalized ACS patients?
- Explore strategies to enhance positive emotional and cognitive states in ACS patients.
- Identify links between these positive states and health behavior (diet, physical activity, and medication).
- Identify other barriers to compliance with health behaviors. What other factors adversely influence compliance with health behaviors in this population?
- Use quantitative measures of positive affect to ensure that the investigators are adequately capturing information about optimism and other positive states
- Develop a preliminary positive psychology-based intervention using the above information
- Explore the feasibility of using methods to objectively measure aspirin adherence and physical activity in this population.
To accomplish these goals, the investigators will interview 30 ACS patients during admission to the inpatient cardiac unit and 12 weeks after discharge. The investigators will identify 15 patients who demonstrate suboptimal adherence as reported by the Medical Outcomes Study Specific Adherence Scale (MOS-SAS) and 15 patients who demonstrate good adherence to health-related behaviors.
For these interviews, the investigators will first ask about positive emotional states that patients have experienced. the investigators will then inquire about potential ideas for increasing these positive emotional states by asking patients what has worked for them in the past and what they have noticed seems to work for others. The investigators will also describe some positive psychology exercises to the patients and ask whether they think those exercises would be effective at increasing positive emotional states. Next, the investigators will ask about health behaviors in which the patient has engaged. The investigators will explore the relationship between these behaviors and positive emotional states. Finally, the investigators will explore with patients some barriers to completing health behaviors and solicit suggestions for overcoming or mitigating these barriers.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Optimal adherence | Other | Other: Qualitative Interview and AdherenceParticipants receive the qualitative interview and adherence intervention. This arm includes participants with scores of greater than or equal to 15 on the Medical Outcomes Study Specific Adherence Scale. This scale ranges from a score of 3 (extremely low adherence to health behaviors) to a score of 18 (extremely high adherence to health behaviors). A score of greater than or equal to 15 suggests optimal adherence to health behaviors. |
| Sub-optimal adherence | Other | Other: Qualitative Interview and AdherenceParticipants receive the qualitative interview and adherence intervention. This arm includes participants with scores of less than 15 on the Medical Outcomes Study Specific Adherence Scale. This scale ranges from a score of 3 (extremely low adherence to health behaviors) to a score of 18 (extremely high adherence to health behaviors). A score of less than 15 suggests sub-optimal adherence to health behaviors. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Admission to Massachusetts General Hospital cardiac floors (Ellison 9, 10, 11)
- Age 18 or older
- Admitted with myocardial infarction or unstable angina
- Score of less than 15 --OR-- greater than or equal to 15 on the adherence scale
- Ability to read and write in English
Key exclusion criteria (2 listed)
- Cognitive deficits as assessed by a 6-item screen
- Medical conditions that prevent interviewing or are likely to lead to death within 6 months
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 |
|---|---|---|
| Qualitative Interview and AdherenceAll participants receive the same intervention. The intervention involves two qualitative interviews per participant. The first interview occurs in the hospital, and the second interview occurs at 12 weeks. Participants also receive a pill bottle that tracks when they take their aspirin. They will also receive a step counter to use for two weeks at the end of the study. | Other | Optimal adherence, Sub-optimal adherence |
Primary outcome
Deficits in positive affect
Time frame: 12 weeks
Qualitative data: The investigators will extract information from 2 quantitative interviews to learn about participants' deficits in positive affect. Quantitative data: Life Orientation Test-Revised, Positive And Negative Affect Scale, Hospital Anxiety and Depression Scale.
Barriers to health behaviors
Time frame: 12 weeks
Qualitative data: The investigators will extract information from 2 qualitative interviews to learn about participants' barriers to completing health behaviors. Quantitative data: Participants will receive a pill bottle that tracks when they take their aspirin. Participants will also receive a step counter to wear for two weeks.
1 secondary outcome
Changes in positive affect
Time frame: Change from baseline positive affect at 12 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 16 Sep 2014.
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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.
Jeff C Huffman, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Qualitative Interview and Adherence in people with Acute Coronary Syndrome and Emotions, run by Massachusetts General Hospital 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 5 inclusion and 2 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 16 Sep 2014. 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?
Deficits in positive affect (time frame: 12 weeks). The study lists 2 primary outcomes in all. 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 16 Sep 2014.