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| ID | Type | Description | Link |
|---|---|---|---|
| 200910778 | Other Identifier | University of Iowa |
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| Name | Class |
|---|---|
| University of Iowa | OTHER |
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The purpose of this research study is to survey patients to learn about their beliefs and behaviors related to the management of heart disease and to discuss options for making healthy lifestyle changes. From the information the investigators get from patients, the investigators hope to develop better methods for taking care of patients who have heart disease.
Coronary heart disease (CHD) is a significant health threat among veterans. Compared to their civilian counterparts, veterans experience greater disability, reinfarction, and mortality following myocardial infarction (MI) and other acute coronary syndromes (ACS). High rates of hypertension, diabetes, and cardiac risk behaviors (e.g., smoking) and low socioeconomic status (SES) further increase veterans' CHD-related morbidity and mortality. The proposed pilot project will establish the feasibility of a telehealth nursing intervention for veterans with CHD who are recovering from MI/ACS. The Veterans Heart Attack Representations Telehealth (Vet-HART) intervention is designed to promote adaptive conceptual change in veterans' beliefs (common sense models or representations) about CHD etiology and self-management and facilitate health behavior changes (e.g., smoking cessation, medication adherence, diet management, and increased physical activity). The long-term goal of this research program is to improve veterans' quality of life (QoL) and reduce their CHD-related morbidity/mortality. The proposed project is the requisite next step in attaining that goal.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Motivational Interview | Experimental | For those subjects randomly assigned to the treatment group, information from their MIHART assessment interview and medical record review will be used to select intervention scripts optimally tailored to each subjects' unique configuration of beliefs and risk factors and they will be re-contacted by telephone at 2-weeks post-hospital discharge to deliver the Vet-HART intervention. The intervention will be administered by a trained research assistant via telephone, working from a semi-structured script tailored to each subject's representations and risk factors, the call will last about 15-30 minutes. |
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| Usual Care | No Intervention | For those randomly assigned to the usual care group, they will receive standard-of-care by their regular primary care provider. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Motivational Interview | Behavioral | For those subjects randomly assigned to the treatment group, information from their MIHART assessment interview and medical record review will be used to select intervention scripts optimally tailored to each subjects' unique configuration of beliefs and risk factors and they will be re-contacted by telephone at 2-weeks post-hospital discharge to deliver the Vet-HART intervention. The intervention will be administered by a trained research assistant via telephone, working from a semi-structured script tailored to each subject's representations and risk factors, the call will last about 15-30 minutes. |
| Measure | Description | Time Frame |
|---|---|---|
| SF-36v Physical Function Scale | Physical Functioning Subscale from the SF-36v. Possible scores range from 0 to 100, with higher scores indicating a better level of functioning. | Change from baseline to 3-months post hospital discharge |
| SF-36v Role Limitations Due to Physical Health Scale | Role Limitations Due to Physical Health Subscale from the SF-36v. Possible scores range from 0 to 100, with higher scores indicating a better level of functioning. | Change from baseline to 3-months post hospital discharge |
| SF-36v Role Limitations Due to Emotional Problems Scale | Role Limitations Due to Emotional Problems Scale from the SF-36v. Possible scores range from 0 to 100, with higher scores indicating a better level of functioning. | Change from baseline to 3-months post hospital discharge |
| SF-36v Energy-Fatigue Scale | Energy-Fatigue Subscale from the SF-36v. Possible scores range from 0 to 100, with higher scores indicating a better level of functioning. | Change from baseline to 3-months post hospital discharge |
| SF-36v Emotional Well-Being Scale | Emotional Well-Being Subscale from the SF-36v. Possible scores range from 0 to 100, with higher scores indicating a better level of functioning. | Change from baseline to 3-months post hospital discharge |
| SF-36v Social Functioning Scale | Social Functioning Subscale from the SF-36v. Possible scores range from 0 to 100, with higher scores indicating a better level of functioning. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark W Vander Weg, PhD MS BA | Iowa City VA Health Care System, Iowa City, IA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Iowa City VA Health Care System, Iowa City, IA | Iowa City | Iowa | 52246-2208 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Motivational Interview | For those subjects randomly assigned to the treatment group, information from their MIHART assessment interview and medical record review will be used to select intervention scripts optimally tailored to each subjects' unique configuration of beliefs and risk factors and they will be re-contacted by telephone at 2-weeks post-hospital discharge to deliver the Vet-HART intervention. The intervention will be administered by a trained research assistant via telephone, working from a semi-structured script tailored to each subject's representations and risk factors, the call will last about 15-30 minutes. |
| FG001 | Usual Care | For those randomly assigned to the usual care group, they will receive standard-of-care by their regular primary care provider. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Motivational Interview | For those subjects randomly assigned to the treatment group, information from their MIHART assessment interview and medical record review will be used to select intervention scripts optimally tailored to each subjects' unique configuration of beliefs and risk factors and they will be re-contacted by telephone at 2-weeks post-hospital discharge to deliver the Vet-HART intervention. The intervention will be administered by a trained research assistant via telephone, working from a semi-structured script tailored to each subject's representations and risk factors, the call will last about 15-30 minutes. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | SF-36v Physical Function Scale | Physical Functioning Subscale from the SF-36v. Possible scores range from 0 to 100, with higher scores indicating a better level of functioning. | Participants who completed the SF-36v at baseline, 1 month, and 3 months. | Posted | Mean | Standard Deviation | units on a scale | Change from baseline to 3-months post hospital discharge |
|
3 Months
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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 | Motivational Interview | For those subjects randomly assigned to the treatment group, information from their MIHART assessment interview and medical record review will be used to select intervention scripts optimally tailored to each subjects' unique configuration of beliefs and risk factors and they will be re-contacted by telephone at 2-weeks post-hospital discharge to deliver the Vet-HART intervention. The intervention will be administered by a trained research assistant via telephone, working from a semi-structured script tailored to each subject's representations and risk factors, the call will last about 15-30 minutes. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mark Vander Weg | Iowa City VA Health Care System | 319-338-0581 | 7717 | mark.vanderweg@va.gov |
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| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D003327 | Coronary Disease |
| D009203 | Myocardial Infarction |
| D054058 | Acute Coronary Syndrome |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D017202 | Myocardial Ischemia |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
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| ID | Term |
|---|---|
| D062405 | Motivational Interviewing |
| ID | Term |
|---|---|
| D037001 | Directive Counseling |
| D003376 | Counseling |
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
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| Change from baseline to 3-months post hospital discharge |
| SF-36v Pain Scale | Pain Subscale from the SF-36v. Possible scores range from 0 to 100, with higher scores indicating a better level of functioning. | Change from baseline to 3-months post hospital discharge |
| SF-36v General Health Scale | General Health Subscale from the SF-36v. Possible scores range from 0 to 100, with higher scores indicating a better level of functioning. | Change from baseline to 3-months post hospital discharge |
| Seattle Angina Questionnaire Physical Limitations Scale | Physical Limitations Subscale from the Seattle Angina Questionnaire. Possible scores range from 0 to 100, with higher scores indicating a better level of functioning. | Change from baseline to 3-months post hospital discharge |
| Seattle Angina Questionnaire Angina Stability Scale | Angina Stability Subscale from the Seattle Angina Questionnaire. Possible scores range from 0 to 100, with higher scores indicating a better level of functioning. | Change from baseline to 3-months post hospital discharge |
| Seattle Angina Questionnaire Angina Frequency Scale | Angina Frequency Subscale from the Seattle Angina Questionnaire. Possible scores range from 0 to 100, with higher scores indicating a better level of functioning. | Change from baseline to 3-months post hospital discharge |
| Seattle Angina Questionnaire Treatment Satisfaction Scale | Treatment Satisfaction Subscale from the Seattle Angina Questionnaire. Possible scores range from 0 to 100, with higher scores indicating a better level of functioning. | Change from baseline to 3-months post hospital discharge |
| Seattle Angina Questionnaire Disease Perception Scale | Disease Perception Subscale from the Seattle Angina Questionnaire. Possible scores range from 0 to 100, with higher scores indicating a better level of functioning. | Change from baseline to 3-months post hospital discharge |
| BG001 | Usual Care | For those randomly assigned to the usual care group, they will receive standard-of-care by their regular primary care provider. |
| BG002 | Total | Total of all reporting groups |
| Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| OG001 | Usual Care | For those randomly assigned to the usual care group, they will receive standard-of-care by their regular primary care provider. |
|
|
| Primary | SF-36v Role Limitations Due to Physical Health Scale | Role Limitations Due to Physical Health Subscale from the SF-36v. Possible scores range from 0 to 100, with higher scores indicating a better level of functioning. | Posted | Mean | Standard Deviation | units on a scale | Change from baseline to 3-months post hospital discharge |
|
|
|
| Primary | SF-36v Role Limitations Due to Emotional Problems Scale | Role Limitations Due to Emotional Problems Scale from the SF-36v. Possible scores range from 0 to 100, with higher scores indicating a better level of functioning. | Posted | Mean | Standard Deviation | units on a scale | Change from baseline to 3-months post hospital discharge |
|
|
|
| Primary | SF-36v Energy-Fatigue Scale | Energy-Fatigue Subscale from the SF-36v. Possible scores range from 0 to 100, with higher scores indicating a better level of functioning. | Posted | Mean | Standard Deviation | units on a scale | Change from baseline to 3-months post hospital discharge |
|
|
|
| Primary | SF-36v Emotional Well-Being Scale | Emotional Well-Being Subscale from the SF-36v. Possible scores range from 0 to 100, with higher scores indicating a better level of functioning. | Posted | Mean | Standard Deviation | units on a scale | Change from baseline to 3-months post hospital discharge |
|
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|
| Primary | SF-36v Social Functioning Scale | Social Functioning Subscale from the SF-36v. Possible scores range from 0 to 100, with higher scores indicating a better level of functioning. | Posted | Mean | Standard Deviation | units on a scale | Change from baseline to 3-months post hospital discharge |
|
|
|
| Primary | SF-36v Pain Scale | Pain Subscale from the SF-36v. Possible scores range from 0 to 100, with higher scores indicating a better level of functioning. | Posted | Mean | Standard Deviation | units on a scale | Change from baseline to 3-months post hospital discharge |
|
|
|
| Primary | SF-36v General Health Scale | General Health Subscale from the SF-36v. Possible scores range from 0 to 100, with higher scores indicating a better level of functioning. | Posted | Mean | Standard Deviation | units on a scale | Change from baseline to 3-months post hospital discharge |
|
|
|
| Primary | Seattle Angina Questionnaire Physical Limitations Scale | Physical Limitations Subscale from the Seattle Angina Questionnaire. Possible scores range from 0 to 100, with higher scores indicating a better level of functioning. | Posted | Mean | Standard Deviation | units on a scale | Change from baseline to 3-months post hospital discharge |
|
|
|
| Primary | Seattle Angina Questionnaire Angina Stability Scale | Angina Stability Subscale from the Seattle Angina Questionnaire. Possible scores range from 0 to 100, with higher scores indicating a better level of functioning. | Note that because 4 participants in the Usual Care group reported that they did not experience chest pain in the prior four weeks, their responses could not be included in the analysis, as the scale measures changes in the severity of chest pain. Therefore, only 2 participants in the Usual Care group contributed to the analysis. | Posted | Mean | Standard Deviation | units on a scale | Change from baseline to 3-months post hospital discharge |
|
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|
| Primary | Seattle Angina Questionnaire Angina Frequency Scale | Angina Frequency Subscale from the Seattle Angina Questionnaire. Possible scores range from 0 to 100, with higher scores indicating a better level of functioning. | Posted | Mean | Standard Deviation | units on a scale | Change from baseline to 3-months post hospital discharge |
|
|
|
| Primary | Seattle Angina Questionnaire Treatment Satisfaction Scale | Treatment Satisfaction Subscale from the Seattle Angina Questionnaire. Possible scores range from 0 to 100, with higher scores indicating a better level of functioning. | Posted | Mean | Standard Deviation | units on a scale | Change from baseline to 3-months post hospital discharge |
|
|
|
| Primary | Seattle Angina Questionnaire Disease Perception Scale | Disease Perception Subscale from the Seattle Angina Questionnaire. Possible scores range from 0 to 100, with higher scores indicating a better level of functioning. | Posted | Mean | Standard Deviation | units on a scale | Change from baseline to 3-months post hospital discharge |
|
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|
| 0 |
| 6 |
| 0 |
| 6 |
| 0 |
| 6 |
| EG001 | Usual Care | For those randomly assigned to the usual care group, they will receive standard-of-care by their regular primary care provider. | 0 | 6 | 0 | 6 | 0 | 6 |
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| D007511 |
| Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |