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This is a randomized controlled pilot trial in approximately 50 acute coronary syndrome patients to determine if a 12 week, telephone-delivered, combined positive psychology-motivational interviewing intervention is feasible and more effective than a motivational interviewing health education program at improving health behaviors and other outcomes. The investigators hypothesize that the intervention will be associated with better mental and physical health outcomes and better health behavior adherence compared to the motivational interviewing health education program.
The initial study visit will occur in-person two weeks after discharge from the hospital. Participants will meet with a member of the study staff (the study "trainer") and complete self-report questionnaires assessing health behavior adherence and mental and physical health. Then, participants will be randomized to receive the positive psychology + motivational interviewing or the motivational interviewing health education interventions. A study interventionist will provide a treatment manual specific to their condition, review the rationale for the initial exercise, and assign the first exercise. If the participant is in the positive psychology + motivational interviewing condition, the trainer will explain the rationale for both the positive psychology and goal-setting portions of the program, and will be assigned the first exercise. Similarly, if the participant is randomized into the motivational interviewing health education program, the interventionist will introduce them to the program and assign the first exercise. Participants in both groups will then be given an accelerometer, which they will be asked to wear for 7 days to ensure that they are comfortable with the device and that useable data can be obtained from the participant. Participants in both groups will then complete twelve 30-minute weekly phone sessions with a study trainer. The phone sessions primarily will include a review of the prior week's session content and a discussion of the rationale and assignment of the next week's exercise/assignment. Upon the completion of these calls, and again at a final follow-up timepoint at 24 weeks, a blinded member of the study staff will call participants to administer self-report outcome measures. Participants will also be asked to wear an accelerometer at each of these follow-up timepoints as an objective measure of physical activity, which they will return by mail to the study staff.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Positive Psychology + Motivational Interviewing | Experimental | Participants will complete weekly positive psychology exercises and will systematically set goals related to physical activity. Study trainers will review the positive psychology exercises on the phone each week and will use motivational interviewing techniques to facilitate goal setting. |
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| Motivational Interviewing Health Education | Active Comparator | Participants will speak on the telephone each week with a study trainer. During these calls, the trainer will provide education about a health behavior (physical activity, medication adherence, diet, stress reduction) and assign an activity related to one health behavior each week. Motivational interviewing techniques will be used throughout to facilitate health behavior changes. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Positive Psychology + Motivational Interviewing | Behavioral | For the positive psychology portion of the intervention, the study trainer will (a) review the week's positive psychology exercise, (b) discuss the rationale of the next week's positive psychology exercise through a guided review of the positive psychology manual, and (c) assign the next week's positive psychology exercise. For the motivational interviewing portion, participants will (a) review their physical activity goal from the prior week, (b) discuss techniques for improving physical activity, and (c) set a physical activity goal for the next week. Study trainers will use motivational interviewing techniques to facilitate goal setting. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of the PP-MI Based Health Behavior Intervention | Feasibility will be measured by examining the number of completed exercises. | 24 weeks |
| Acceptability of the PP-MI Exercises: Utility Score | Participants will provide ratings of utility after each exercise, measured on a 10-point Likert scale (0=not at all helpful; 10=very helpful). Weekly utility ratings were averaged to provide an overall utility score of the exercises. | Weeks 1-12 |
| Acceptability of the PP-MI Exercises: Ease Score | Participants will provide ratings of ease after each exercise, measured on a 10-point Likert scale (0=very difficult; 10=very easy). Weekly ratings were averaged to provide an overall ease of the exercises. | Weeks 1-12 |
| Measure | Description | Time Frame |
|---|---|---|
| Minutes of Moderate to Vigorous Physical Activity (Actigraph) | ActiGraph GT3X+ step counters are validated as measures of physical activity and have been used in numerous studies of physical activity in patients with medical illness. In this trial, participants will wear the accelerometer for one week at 12 weeks, and another week at 24 weeks to assess the feasibility of doing so and to ensure adequate capture of physical activity. In our analysis, data on pre-ACS activity was collected using the International Physical Activity Questionnaire (IPAQ) to control for baseline activity. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeff Huffman, MD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
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69 participants enrolled in the study but 22 either withdrew their consent or failed to attend their first in-person visit before randomization. Forty-seven individuals were randomized to a treatment condition.
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| ID | Title | Description |
|---|---|---|
| FG000 | Positive Psychology + Motivational Interviewing | Participants will complete weekly positive psychology exercises and will systematically set goals related to physical activity. Study trainers will review the positive psychology exercises on the phone each week and will use motivational interviewing techniques to facilitate goal setting. Positive Psychology + Motivational Interviewing: For the positive psychology portion of the intervention, the study trainer will (a) review the week's positive psychology exercise, (b) discuss the rationale of the next week's positive psychology exercise through a guided review of the positive psychology manual, and (c) assign the next week's positive psychology exercise. For the motivational interviewing portion, participants will (a) review their physical activity goal from the prior week, (b) discuss techniques for improving physical activity, and (c) set a physical activity goal for the next week. Study trainers will use motivational interviewing techniques to facilitate goal setting. |
| FG001 | Motivational Interviewing Health Education | Participants will speak on the telephone each week with a study trainer. During these calls, the trainer will provide education about a health behavior (physical activity, medication adherence, diet, stress reduction) and assign an activity related to one health behavior each week. Motivational interviewing techniques will be used throughout to facilitate health behavior changes. Motivational Interviewing Health Education: Each week, participants will learn about a different health behavior topic related to cardiac health. They will also be introduced to motivational interviewing topics in concert with the health behavior education topics. The intervention is divided into five sections, focusing on five different important cardiac health-related topics (recovery from an acute cardiac illness, physical activity, a heart-healthy diet, medication adherence, and stress reduction). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Positive Psychology + Motivational Interviewing | Participants will complete weekly positive psychology exercises and will systematically set goals related to physical activity. Study trainers will review the positive psychology exercises on the phone each week and will use motivational interviewing techniques to facilitate goal setting. Positive Psychology + Motivational Interviewing: For the positive psychology portion of the intervention, the study trainer will (a) review the week's positive psychology exercise, (b) discuss the rationale of the next week's positive psychology exercise through a guided review of the positive psychology manual, and (c) assign the next week's positive psychology exercise. For the motivational interviewing portion, participants will (a) review their physical activity goal from the prior week, (b) discuss techniques for improving physical activity, and (c) set a physical activity goal for the next week. Study trainers will use motivational interviewing techniques to facilitate goal setting. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Feasibility of the PP-MI Based Health Behavior Intervention | Feasibility will be measured by examining the number of completed exercises. | Posted | Mean | Standard Deviation | exercises completed | 24 weeks |
|
24 weeks
Adverse events are "any untoward or unfavorable medical occurrence in a human subject including any abnormal sign, symptom or disease...whether or not associated with the subject's participation in the research."
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Positive Psychology + Motivational Interviewing | Participants will complete weekly positive psychology exercises and will systematically set goals related to physical activity. Study trainers will review the positive psychology exercises on the phone each week and will use motivational interviewing techniques to facilitate goal setting. Positive Psychology + Motivational Interviewing: For the positive psychology portion of the intervention, the study trainer will (a) review the week's positive psychology exercise, (b) discuss the rationale of the next week's positive psychology exercise through a guided review of the positive psychology manual, and (c) assign the next week's positive psychology exercise. For the motivational interviewing portion, participants will (a) review their physical activity goal from the prior week, (b) discuss techniques for improving physical activity, and (c) set a physical activity goal for the next week. Study trainers will use motivational interviewing techniques to facilitate goal setting. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Unexpected chest and back pain | General disorders | Non-systematic Assessment | Patient admitted to hospital for chest and back pain. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Allergic reaction | General disorders | Non-systematic Assessment | Patient was admitted to the ED for an allergic reaction. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jeff Huffman | Massachusetts General Hospital | 617-724-2910 | JHUFFMAN@mgh.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 6, 2018 | Aug 22, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D000080032 | Psychology, Positive |
| D062405 | Motivational Interviewing |
| ID | Term |
|---|---|
| D011584 | Psychology |
| D001525 | Behavioral Sciences |
| D004191 | Behavioral Disciplines and Activities |
| D037001 | Directive Counseling |
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Randomized, single-blinded, controlled trial
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Participants and treating study staff will be aware of the patient's treatment condition. However, follow-up assessments will be performed by a study staff member that is masked to the participant's treatment condition.
|
| Motivational Interviewing Health Education | Behavioral | Each week, participants will learn about a different health behavior topic related to cardiac health. They will also be introduced to motivational interviewing topics in concert with the health behavior education topics. The intervention is divided into five sections, focusing on five different important cardiac health-related topics (recovery from an acute cardiac illness, physical activity, a heart-healthy diet, medication adherence, and stress reduction). |
|
| MVPA at 12 weeks and 24 weeks |
| Change in Medication Adherence | Measured by Self-Reported Medication Adherence (SRMA), a two-item self-report medication adherence scale measuring percentage of time (in 10% increments) patients report taking their heart medications in the past one and two weeks. Minimum: 0, Maximum:100. Change was calculated by subtracting the score at baseline from the score at 12 weeks and 24 weeks. Higher score indicates greater levels of medication adherence. | Change in score from Baseline to 12 weeks, 24 weeks |
| Change in Dietary Adherence | Measured by the MEDFICTS scale, a National Cholesterol Education Program-developed scale inquiring about saturated fat. Minimum= 0; Maximum= 216. Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks. Higher scores indicate lower levels of dietary adherence. | Change in score from Baseline to 12 weeks, 24 weeks |
| Change in Positive Affect | The positive affect items on the Positive and Negative Affect Schedule (PANAS), a well-validated scale used in other intervention trials and in patients with medical illnesses, will be used to measure positive affect. (Range: 10-50). Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks. Higher scores indicate higher levels of positive affect. | Change in score from Baseline to 12 weeks, 24 weeks |
| Change in Trait Optimism | Life Orientation Test-Revised is a well-validated 6-item instrument used to measure dispositional optimism. (Range: 0-24) Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks. Higher scores indicate higher levels of optimism. | Change in score from baseline to 12 week, 24 week |
| Change in State Optimism | Measured by the State Optimism Scale developed by our team (SOM), which aims to capture the changeable nature of optimism based on time and situation. Minimum:7, Maximum:35. The higher number indicates a greater level of optimism. Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks. | Change of score from Baseline to 12 weeks, 24 weeks |
| Changes in HADS-A Scores | The Hospital Anxiety and Depression Scale will be used to measure depression and anxiety. This is a well-validated scale with few somatic symptom items that can confound mood/anxiety assessment in medically-ill patients. (Range: 0-21) Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks. Higher scores indicate higher levels of anxiety. | Change in score from Baseline to 12 week, 24 week |
| Change in HADS-D Scores | The Hospital Anxiety and Depression Scale will be used to measure depression and anxiety. This is a well-validated scale with few somatic symptom items that can confound mood/anxiety assessment in medically-ill patients.(Range: 0-21). Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks. Higher scores indicate worse outcome (i.e. greater levels of depression). | Change in score from Baseline to 12 week, 24 week |
| Change in Physical Function | Measured by the Duke Activity Status Index (DASI), a 12-item questionnaire that inquires about activities of daily living, basic physical activity, and more strenuous physical function to gauge overall functional capacity. Minimum: 0, Maximum: 58.2. Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks. Higher scores indicate greater levels of functional capacity. | Change of score from Baseline to 12 week, 24 week |
| Change in SF-12 Scores (Physical) | The Medical Outcomes Study Short Form-12 (SF-12) will be used to measure quality of life. This is an instrument which has been used in multiple cardiac studies in the past. (SF-12 Mental Composite Score and Physical Composite Score Range: 0-100 each). Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks. Higher scores indicate higher level of health related QoL. | Change of score from Baseline to 12 week, 24 week |
| Change in SF-12 Scores (Mental) | The Medical Outcomes Study Short Form-12 (SF-12) will be used to measure quality of life. This is an instrument which has been used in multiple cardiac studies in the past. (SF-12 Mental Composite Score and Physical Composite Score Range: 0-100 each). Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks. Higher scores indicate higher level of health related QoL. | Change of score from baseline to 12 and 24 weeks. |
| Change in Adherence to Health Behaviors | Three Medical Outcomes Study Specific Adherence Scale (MOS SAS) items assessing medication, diet, and exercise, will be measured individually and as a composite score. (Range: 3-18) Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks. Higher scores indicate better adherence to health behaviors. | Change of score from Baseline to 12 week, 24 week |
| Change in Cardiac Symptoms | Measured by a checklist taken from the Women and Ischemia Syndrome Evaluation Study (WISE) to assess the presence and intensity of ten cardiac symptoms felt to best capture the range of symptoms experienced by ACS patients. Minimum: 0, Maximum: 30. Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks. Higher scores indicate greater levels of cardiac symptoms. | Change of score from Baseline to 12 week, 24 week |
| Change in Physical Activity | Measured by the self-report International Physical Activity Questionnaire (IPAQ). The measure asseses the types of intensity of physical activity that people do as part of their daily lives. All activities are converted to multiples of resting energy expenditure (MET) minutes per week. Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks. | Change of score from Baseline to 12 week, 24 week |
| Change in Perceived Stress | Measured by the Perceived Stress Scale (PSS-4) measure. Minimum: 0, Maximum: 16. Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks Higher scores indicate greater levels of stress. | Change of score from Baseline to 12 week, 24 week |
| Terminated due to cognitive problem |
|
| BG001 | Motivational Interviewing Health Education | Participants will speak on the telephone each week with a study trainer. During these calls, the trainer will provide education about a health behavior (physical activity, medication adherence, diet, stress reduction) and assign an activity related to one health behavior each week. Motivational interviewing techniques will be used throughout to facilitate health behavior changes. Motivational Interviewing Health Education: Each week, participants will learn about a different health behavior topic related to cardiac health. They will also be introduced to motivational interviewing topics in concert with the health behavior education topics. The intervention is divided into five sections, focusing on five different important cardiac health-related topics (recovery from an acute cardiac illness, physical activity, a heart-healthy diet, medication adherence, and stress reduction). |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Medication Adherence | Medication adherence was measured by the Self-Reported Medication Adherence (SRMA), a two-item self-report medication adherence scale measuring percentage of time (in 10% increments) patients report taking their heart medications in the past one and two weeks. Minimum: 0, Maximum:100. This measure was used at Baseline, Week 12, and Week 24. | Mean | Standard Deviation | percentage of time |
|
| Dietary Adherence | Measured by the MEDFICTS scale, a National Cholesterol Education Program-developed scale inquiring about saturated fat. Minimum= 0; Maximum= 216. Measure was used at Baseline, Week 12, and Week 24. | Mean | Standard Deviation | score on a scale |
|
| Positive Affect | The positive affect items on the Positive and Negative Affect Schedule (PANAS), a well-validated scale used in other intervention trials and in patients with medical illnesses, will be used to measure positive affect. (Range: 10-50). Higher scores indicate higher levels of positive affect. This measure was used at Baseline, Week 12, and Week 24. | Mean | Standard Deviation | score on a scale |
|
| Trait Optimism | Life Orientation Test-Revised is a well-validated 6-item instrument used to measure dispositional optimism. (Range: 0-24) Higher scores indicate higher levels of optimism. This measured was used at Baseline, Week 12, and Week 24. | Mean | Standard Deviation | score on a scale |
|
| State Optimisim | Measured by the State Optimism Scale developed by our team (SOM), which aims to capture the changeable nature of optimism based on time and situation. Minimum:7, Maximum:35. The higher number indicates a greater level of optimism. This measure was used at Baseline, Week 12, and Week 24. | Mean | Standard Deviation | score on a scale |
|
| HADS-A Score | The Hospital Anxiety and Depression Scale will be used to measure depression and anxiety. This is a well-validated scale with few somatic symptom items that can confound mood/anxiety assessment in medically-ill patients. (Range: 0-21) Higher scores indicate higher levels of anxiety. This measure was used at Baseline, Week 12, and Week 24. | Mean | Standard Deviation | score on a scale |
|
| HADS-D Score | The Hospital Anxiety and Depression Scale will be used to measure depression and anxiety. This is a well-validated scale with few somatic symptom items that can confound mood/anxiety assessment in medically-ill patients.(Range: 0-21). Higher scores indicate worse outcome (i.e. greater levels of depression). This measure was used at Baseline, Week 12, and Week 24. | Mean | Standard Deviation | score on a scale |
|
| Physical Function | Measured by the Duke Activity Status Index (DASI), a 12-item questionnaire that inquires about activities of daily living, basic physical activity, and more strenuous physical function to gauge overall functional capacity. Minimum: 0, Maximum: 58.2. Higher scores indicate greater levels of functional capacity. This measure was used at Baseline, Week 12, and Week 24. | Mean | Standard Deviation | score on a scale |
|
| SF-12 Scores (Physical) | The Medical Outcomes Study Short Form-12 (SF-12) will be used to measure quality of life. This is an instrument which has been used in multiple cardiac studies in the past. (SF-12 Mental Composite Score and Physical Composite Score Range: 0-100 each). Higher scores indicate higher level of health related QoL. This measure was used at Baseline, Week 12, and Week 24. | Mean | Standard Deviation | score on a scale |
|
| SF-12 Scores (Mental) | The Medical Outcomes Study Short Form-12 (SF-12) will be used to measure quality of life. This is an instrument which has been used in multiple cardiac studies in the past. (SF-12 Mental Composite Score and Physical Composite Score Range: 0-100 each). Higher scores indicate higher level of health related QoL. This measure was used at Baseline, Week 12, and Week 24. | Mean | Standard Deviation | score on a scale |
|
| Adherence to Health Behaviors | Three Medical Outcomes Study Specific Adherence Scale (MOS SAS) items assessing medication, diet, and exercise, will be measured individually and as a composite score. (Range: 3-18) Higher scores indicate better adherence to health behaviors. This measure was used at Baseline, Week 12, and Week 24. | Mean | Standard Deviation | score on a scale |
|
| Cardiac Symptoms | Measured by a checklist taken from the Women and Ischemia Syndrome Evaluation Study (WISE) to assess the presence and intensity of ten cardiac symptoms felt to best capture the range of symptoms experienced by ACS patients. Minimum: 0, Maximum: 30. Higher scores indicate greater levels of cardiac symptoms. This measure was used at Baseline, Week 12, and Week 24. | Mean | Standard Deviation | score on a scale |
|
| Physical Activity | Measured by the self-report International Physical Activity Questionnaire (IPAQ). The measure assess the types of intensity of physical activity that people do as part of their daily lives. All activities are converted to multiples of resting energy expenditure (MET) minutes per week. This measure was used at Baseline, Week 12, and Week 24. | Mean | Standard Deviation | MET-minutes per week |
|
| Perceived Stress | Measured by the Perceived Stress Scale (PSS-4) measure. Minimum: 0, Maximum: 16. Higher scores indicate greater levels of stress. This measure was used at Baseline, Week 12, and Week 24. | Mean | Standard Deviation | score on a scale |
|
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| Primary | Acceptability of the PP-MI Exercises: Utility Score | Participants will provide ratings of utility after each exercise, measured on a 10-point Likert scale (0=not at all helpful; 10=very helpful). Weekly utility ratings were averaged to provide an overall utility score of the exercises. | Posted | Mean | Standard Deviation | units on a scale | Weeks 1-12 |
|
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|
| Primary | Acceptability of the PP-MI Exercises: Ease Score | Participants will provide ratings of ease after each exercise, measured on a 10-point Likert scale (0=very difficult; 10=very easy). Weekly ratings were averaged to provide an overall ease of the exercises. | Posted | Mean | Standard Deviation | units on a scale | Weeks 1-12 |
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|
| Secondary | Minutes of Moderate to Vigorous Physical Activity (Actigraph) | ActiGraph GT3X+ step counters are validated as measures of physical activity and have been used in numerous studies of physical activity in patients with medical illness. In this trial, participants will wear the accelerometer for one week at 12 weeks, and another week at 24 weeks to assess the feasibility of doing so and to ensure adequate capture of physical activity. In our analysis, data on pre-ACS activity was collected using the International Physical Activity Questionnaire (IPAQ) to control for baseline activity. | Not everyone provided follow-up data at both time points. | Posted | Mean | Standard Deviation | minutes/day | MVPA at 12 weeks and 24 weeks |
|
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| Secondary | Change in Medication Adherence | Measured by Self-Reported Medication Adherence (SRMA), a two-item self-report medication adherence scale measuring percentage of time (in 10% increments) patients report taking their heart medications in the past one and two weeks. Minimum: 0, Maximum:100. Change was calculated by subtracting the score at baseline from the score at 12 weeks and 24 weeks. Higher score indicates greater levels of medication adherence. | Number of participants analyzed in Week 12 differs from that analyzed at Week 24 because not everyone provided data at both time points. | Posted | Mean | Standard Deviation | percentage of time | Change in score from Baseline to 12 weeks, 24 weeks |
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| Secondary | Change in Dietary Adherence | Measured by the MEDFICTS scale, a National Cholesterol Education Program-developed scale inquiring about saturated fat. Minimum= 0; Maximum= 216. Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks. Higher scores indicate lower levels of dietary adherence. | Number of participants analyzed in Week 12 differs from that analyzed at Week 24 because not everyone who provided data at both time points. | Posted | Mean | Standard Deviation | score on a scale | Change in score from Baseline to 12 weeks, 24 weeks |
|
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| Secondary | Change in Positive Affect | The positive affect items on the Positive and Negative Affect Schedule (PANAS), a well-validated scale used in other intervention trials and in patients with medical illnesses, will be used to measure positive affect. (Range: 10-50). Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks. Higher scores indicate higher levels of positive affect. | Number of participants analyzed in Week 12 differs from that analyzed at Week 24 because not everyone provided data at both time points. | Posted | Mean | Standard Deviation | score on a scale | Change in score from Baseline to 12 weeks, 24 weeks |
|
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| Secondary | Change in Trait Optimism | Life Orientation Test-Revised is a well-validated 6-item instrument used to measure dispositional optimism. (Range: 0-24) Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks. Higher scores indicate higher levels of optimism. | Number of participants analyzed in Week 12 differs from that analyzed at Week 24 because not everyone provided data at both time points. | Posted | Mean | Standard Deviation | score on a scale | Change in score from baseline to 12 week, 24 week |
|
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| Secondary | Change in State Optimism | Measured by the State Optimism Scale developed by our team (SOM), which aims to capture the changeable nature of optimism based on time and situation. Minimum:7, Maximum:35. The higher number indicates a greater level of optimism. Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks. | Not all participants provided data at all follow-up points. | Posted | Mean | Standard Deviation | score on a scale | Change of score from Baseline to 12 weeks, 24 weeks |
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| Secondary | Changes in HADS-A Scores | The Hospital Anxiety and Depression Scale will be used to measure depression and anxiety. This is a well-validated scale with few somatic symptom items that can confound mood/anxiety assessment in medically-ill patients. (Range: 0-21) Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks. Higher scores indicate higher levels of anxiety. | Number of participants analyzed in Week 12 differs from that analyzed at Week 24 because not everyone provided data at both time points. | Posted | Mean | Standard Deviation | score on a scale | Change in score from Baseline to 12 week, 24 week |
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| Secondary | Change in HADS-D Scores | The Hospital Anxiety and Depression Scale will be used to measure depression and anxiety. This is a well-validated scale with few somatic symptom items that can confound mood/anxiety assessment in medically-ill patients.(Range: 0-21). Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks. Higher scores indicate worse outcome (i.e. greater levels of depression). | We will use a random effects regression model with a random intercept for each participant. | Posted | Mean | Standard Deviation | score on a scale | Change in score from Baseline to 12 week, 24 week |
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| Secondary | Change in Physical Function | Measured by the Duke Activity Status Index (DASI), a 12-item questionnaire that inquires about activities of daily living, basic physical activity, and more strenuous physical function to gauge overall functional capacity. Minimum: 0, Maximum: 58.2. Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks. Higher scores indicate greater levels of functional capacity. | Number of participants analyzed in Week 12 differs from that analyzed at Week 24 because not everyone provided data at both time points. | Posted | Mean | Standard Error | score on a scale | Change of score from Baseline to 12 week, 24 week |
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| Secondary | Change in SF-12 Scores (Physical) | The Medical Outcomes Study Short Form-12 (SF-12) will be used to measure quality of life. This is an instrument which has been used in multiple cardiac studies in the past. (SF-12 Mental Composite Score and Physical Composite Score Range: 0-100 each). Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks. Higher scores indicate higher level of health related QoL. | Number of participants analyzed in Week 12 differs from that analyzed at Week 24 because not everyone provided data at both time points. | Posted | Mean | Standard Deviation | score on a scale | Change of score from Baseline to 12 week, 24 week |
|
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| Secondary | Change in SF-12 Scores (Mental) | The Medical Outcomes Study Short Form-12 (SF-12) will be used to measure quality of life. This is an instrument which has been used in multiple cardiac studies in the past. (SF-12 Mental Composite Score and Physical Composite Score Range: 0-100 each). Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks. Higher scores indicate higher level of health related QoL. | Number of participants analyzed in Week 12 differs from that analyzed at Week 24 because not everyone provided data at both time points. | Posted | Mean | Standard Deviation | score on a scale | Change of score from baseline to 12 and 24 weeks. |
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| Secondary | Change in Adherence to Health Behaviors | Three Medical Outcomes Study Specific Adherence Scale (MOS SAS) items assessing medication, diet, and exercise, will be measured individually and as a composite score. (Range: 3-18) Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks. Higher scores indicate better adherence to health behaviors. | Number of participants analyzed in Week 12 differs from that analyzed at Week 24 because not everyone provided data at both time points. | Posted | Mean | Standard Deviation | score on a scale | Change of score from Baseline to 12 week, 24 week |
|
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| Secondary | Change in Cardiac Symptoms | Measured by a checklist taken from the Women and Ischemia Syndrome Evaluation Study (WISE) to assess the presence and intensity of ten cardiac symptoms felt to best capture the range of symptoms experienced by ACS patients. Minimum: 0, Maximum: 30. Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks. Higher scores indicate greater levels of cardiac symptoms. | Not all participants provided data at all follow-up points. | Posted | Mean | Standard Deviation | score on a scale | Change of score from Baseline to 12 week, 24 week |
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| Secondary | Change in Physical Activity | Measured by the self-report International Physical Activity Questionnaire (IPAQ). The measure asseses the types of intensity of physical activity that people do as part of their daily lives. All activities are converted to multiples of resting energy expenditure (MET) minutes per week. Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks. | Number of participants analyzed in Week 12 differs from that analyzed at Week 24 because not everyone provided data at both time points. | Posted | Mean | Standard Deviation | MET-minutes per week | Change of score from Baseline to 12 week, 24 week |
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| Secondary | Change in Perceived Stress | Measured by the Perceived Stress Scale (PSS-4) measure. Minimum: 0, Maximum: 16. Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks Higher scores indicate greater levels of stress. | Not all participants provided data at all follow-up points. | Posted | Mean | Standard Deviation | score on a scale | Change of score from Baseline to 12 week, 24 week |
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| 0 |
| 24 |
| 11 |
| 24 |
| 7 |
| 24 |
| EG001 | Motivational Interviewing Health Education | Participants will speak on the telephone each week with a study trainer. During these calls, the trainer will provide education about a health behavior (physical activity, medication adherence, diet, stress reduction) and assign an activity related to one health behavior each week. Motivational interviewing techniques will be used throughout to facilitate health behavior changes. Motivational Interviewing Health Education: Each week, participants will learn about a different health behavior topic related to cardiac health. They will also be introduced to motivational interviewing topics in concert with the health behavior education topics. The intervention is divided into five sections, focusing on five different important cardiac health-related topics (recovery from an acute cardiac illness, physical activity, a heart-healthy diet, medication adherence, and stress reduction). | 0 | 23 | 11 | 23 | 6 | 23 |
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| Unexpected Coronary Artery Syndrome | Cardiac disorders | Non-systematic Assessment | Patient admitted to hospital for CAD. |
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| Unexpected aneurysm | General disorders | Non-systematic Assessment | Patient admitted to hospital for nonruptured cerebral aneurysm. |
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| Unexpected NSTEMI | Cardiac disorders | Non-systematic Assessment | Patient admitted to hospital for NSTEMI. |
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| Unexpected hospital admission due to alt ms | General disorders | Non-systematic Assessment | Patient admitted to hospital for alt ms. |
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| Unexpected fever | General disorders | Non-systematic Assessment | Patient admitted to hospital for fever. |
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| Unexpected hypotension | Cardiac disorders | Non-systematic Assessment | Patient admitted to hospital for hypotension. |
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| Unexpected sepsis | General disorders | Non-systematic Assessment | Patient admitted to hospital for sepsis. |
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| Unexpected GI bleed | General disorders | Non-systematic Assessment | Patient admitted to hospital for GI bleed. |
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| Unexpected calculus of gallbladder | General disorders | Non-systematic Assessment | Patient admitted to hospital for calculus of gallbladder without cholecystitis. |
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| Unexpected melena | General disorders | Non-systematic Assessment | Patient admitted to hospital for melena. |
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| Unexpected mass | General disorders | Non-systematic Assessment | Patient admitted to hospital for left renal mass. |
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| Unexpected rectal bleeding | General disorders | Non-systematic Assessment | Patient admitted to hospital for Onc/Rectal bleeding. |
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| Lymphoma | General disorders | Non-systematic Assessment | Patient admitted to hospital for lymphoma. |
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| Unexpected A-FIB | General disorders | Non-systematic Assessment | Patient admitted to hospital for A-FIB |
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| Unexpected Carpal Tunnel Syndrome | General disorders | Non-systematic Assessment | Patient admitted to FH for RIGHT CARPAL TUNNEL SYNDROME (SEVERE) |
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| Unexpected eye damage | Eye disorders | Non-systematic Assessment | Patient admitted to hospital for Retinal detachment with single break, right eye. |
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| Unexpected blood in stool | General disorders | Non-systematic Assessment | Patient admitted to hospital for blood in stool. |
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| Unexpected malignant neoplasm of colon | General disorders | Non-systematic Assessment | Patient admitted to hospital for malignant neoplasm of descending colon. |
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| Stomach cramps and vomiting | General disorders | Non-systematic Assessment | Participant was admitted to ED for stomach cramps and vomiting. |
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| Throat swelling | General disorders | Non-systematic Assessment | Participant was admitted to hospital for swelling in throat. |
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| Abdominal pain | General disorders | Non-systematic Assessment | Participant was admitted to ED for abdominal pain. |
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| Chest pain | Cardiac disorders | Non-systematic Assessment | Patient admitted to ED for chest pain |
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| Chest discomfort | Cardiac disorders | Non-systematic Assessment | Patient admitted to ED for chest discomfort |
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| Unexpected balance issues | General disorders | Non-systematic Assessment | Patient admitted to ED for unexpected balance issues |
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Not provided
Not provided
| D003376 | Counseling |
| D008605 | Mental Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| MVPA at 24-week |
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| 24 weeks |
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| 24 weeks |
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| 24 weeks |
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| 24 weeks |
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| Change in SOM at 24 weeks |
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| 24 weeks |
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| 24 weeks |
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| 24 weeks |
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| 24 weeks |
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| 24 week |
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| 24 weeks |
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| 24 weeks |
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| 24 weeks |
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| 24 weeks |
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