Heart Disease
Conditions
Keywords
coronary heart disease (CHD), myocardial infarction (MI), acute coronary syndromes (ACS)
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALMotivational 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.
Sponsors
University of Iowa
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Admission to an inpatient medicine unit for MI, ACS, and coronary angiography * Age
Exclusion criteria
* Altered mental status * Language barriers * Dementia or Cognitive Impairment * Diagnostic Study * Resident in long-term care facility prior to the present admission * Planned discharge to a skilled or intermediate care facility or hospice * Lack of access to a functioning phone
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| SF-36v Physical Function Scale | Change from baseline to 3-months post hospital discharge | Physical Functioning Subscale from the SF-36v. Possible scores range from 0 to 100, with higher scores indicating a better level of functioning. |
| SF-36v Role Limitations Due to Physical Health Scale | Change from baseline to 3-months post hospital discharge | 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. |
| SF-36v Role Limitations Due to Emotional Problems Scale | Change from baseline to 3-months post hospital discharge | 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. |
| SF-36v Energy-Fatigue Scale | Change from baseline to 3-months post hospital discharge | Energy-Fatigue Subscale from the SF-36v. Possible scores range from 0 to 100, with higher scores indicating a better level of functioning. |
| SF-36v Emotional Well-Being Scale | Change from baseline to 3-months post hospital discharge | Emotional Well-Being Subscale from the SF-36v. Possible scores range from 0 to 100, with higher scores indicating a better level of functioning. |
| SF-36v Social Functioning Scale | Change from baseline to 3-months post hospital discharge | Social Functioning Subscale from the SF-36v. Possible scores range from 0 to 100, with higher scores indicating a better level of functioning. |
| SF-36v Pain Scale | Change from baseline to 3-months post hospital discharge | Pain Subscale from the SF-36v. Possible scores range from 0 to 100, with higher scores indicating a better level of functioning. |
| SF-36v General Health Scale | Change from baseline to 3-months post hospital discharge | General Health Subscale from the SF-36v. Possible scores range from 0 to 100, with higher scores indicating a better level of functioning. |
| Seattle Angina Questionnaire Physical Limitations Scale | Change from baseline to 3-months post hospital discharge | Physical Limitations Subscale from the Seattle Angina Questionnaire. Possible scores range from 0 to 100, with higher scores indicating a better level of functioning. |
| Seattle Angina Questionnaire Angina Stability Scale | Change from baseline to 3-months post hospital discharge | Angina Stability Subscale from the Seattle Angina Questionnaire. Possible scores range from 0 to 100, with higher scores indicating a better level of functioning. |
| Seattle Angina Questionnaire Angina Frequency Scale | Change from baseline to 3-months post hospital discharge | Angina Frequency Subscale from the Seattle Angina Questionnaire. Possible scores range from 0 to 100, with higher scores indicating a better level of functioning. |
| Seattle Angina Questionnaire Treatment Satisfaction Scale | Change from baseline to 3-months post hospital discharge | Treatment Satisfaction Subscale from the Seattle Angina Questionnaire. Possible scores range from 0 to 100, with higher scores indicating a better level of functioning. |
| Seattle Angina Questionnaire Disease Perception Scale | Change from baseline to 3-months post hospital discharge | Disease Perception Subscale from the Seattle Angina Questionnaire. Possible scores range from 0 to 100, with higher scores indicating a better level of functioning. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 6 |
| Usual Care For those randomly assigned to the usual care group, they will receive standard-of-care by their regular primary care provider. | 6 |
| Total | 12 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 3 | 0 |
Baseline characteristics
| Characteristic | Motivational Interview | Total | Usual Care |
|---|---|---|---|
| Age, Continuous | 68.33 Years STANDARD_DEVIATION 11.98 | 67.00 Years STANDARD_DEVIATION 10.05 | 65.67 Years STANDARD_DEVIATION 8.64 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 8 Participants | 5 Participants |
| Race (NIH/OMB) White | 3 Participants | 4 Participants | 1 Participants |
| Region of Enrollment United States | 6 participants | 12 participants | 6 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 6 Participants | 12 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 0 / 6 |
| other Total, other adverse events | 0 / 6 | 0 / 6 |
| serious Total, serious adverse events | 0 / 6 | 0 / 6 |
Outcome results
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.
Time frame: Change from baseline to 3-months post hospital discharge
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Motivational Interview | Seattle Angina Questionnaire Angina Frequency Scale | 20.00 units on a scale | Standard Deviation 43.59 |
| Usual Care | Seattle Angina Questionnaire Angina Frequency Scale | 16.67 units on a scale | Standard Deviation 22.51 |
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.
Time frame: Change from baseline to 3-months post hospital discharge
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Motivational Interview | Seattle Angina Questionnaire Angina Stability Scale | 25.00 units on a scale | Standard Deviation 66.14 |
| Usual Care | Seattle Angina Questionnaire Angina Stability Scale | -12.50 units on a scale | Standard Deviation 17.68 |
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.
Time frame: Change from baseline to 3-months post hospital discharge
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Motivational Interview | Seattle Angina Questionnaire Disease Perception Scale | 13.89 units on a scale | Standard Deviation 9.62 |
| Usual Care | Seattle Angina Questionnaire Disease Perception Scale | 9.72 units on a scale | Standard Deviation 17.01 |
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.
Time frame: Change from baseline to 3-months post hospital discharge
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Motivational Interview | Seattle Angina Questionnaire Physical Limitations Scale | -5.93 units on a scale | Standard Deviation 8.98 |
| Usual Care | Seattle Angina Questionnaire Physical Limitations Scale | 3.33 units on a scale | Standard Deviation 30.43 |
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.
Time frame: Change from baseline to 3-months post hospital discharge
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Motivational Interview | Seattle Angina Questionnaire Treatment Satisfaction Scale | -3.92 units on a scale | Standard Deviation 33.45 |
| Usual Care | Seattle Angina Questionnaire Treatment Satisfaction Scale | 7.84 units on a scale | Standard Deviation 10.95 |
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.
Time frame: Change from baseline to 3-months post hospital discharge
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Motivational Interview | SF-36v Emotional Well-Being Scale | -14.67 units on a scale | Standard Deviation 37.86 |
| Usual Care | SF-36v Emotional Well-Being Scale | -2.00 units on a scale | Standard Deviation 7.9 |
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.
Time frame: Change from baseline to 3-months post hospital discharge
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Motivational Interview | SF-36v Energy-Fatigue Scale | -5.00 units on a scale | Standard Deviation 42.65 |
| Usual Care | SF-36v Energy-Fatigue Scale | 1.67 units on a scale | Standard Deviation 23.49 |
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.
Time frame: Change from baseline to 3-months post hospital discharge
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Motivational Interview | SF-36v General Health Scale | -5.00 units on a scale | Standard Deviation 18.03 |
| Usual Care | SF-36v General Health Scale | 4.17 units on a scale | Standard Deviation 17.15 |
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.
Time frame: Change from baseline to 3-months post hospital discharge
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Motivational Interview | SF-36v Pain Scale | -5.00 units on a scale | Standard Deviation 13.23 |
| Usual Care | SF-36v Pain Scale | 14.17 units on a scale | Standard Deviation 13.1 |
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.
Time frame: Change from baseline to 3-months post hospital discharge
Population: Participants who completed the SF-36v at baseline, 1 month, and 3 months.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Motivational Interview | SF-36v Physical Function Scale | -6.67 units on a scale | Standard Deviation 7.64 |
| Usual Care | SF-36v Physical Function Scale | 13.33 units on a scale | Standard Deviation 12.52 |
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.
Time frame: Change from baseline to 3-months post hospital discharge
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Motivational Interview | SF-36v Role Limitations Due to Emotional Problems Scale | -27.78 units on a scale | Standard Deviation 25.46 |
| Usual Care | SF-36v Role Limitations Due to Emotional Problems Scale | 5.56 units on a scale | Standard Deviation 13.61 |
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.
Time frame: Change from baseline to 3-months post hospital discharge
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Motivational Interview | SF-36v Role Limitations Due to Physical Health Scale | -22.92 units on a scale | Standard Deviation 35.54 |
| Usual Care | SF-36v Role Limitations Due to Physical Health Scale | 9.38 units on a scale | Standard Deviation 36.39 |
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.
Time frame: Change from baseline to 3-months post hospital discharge
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Motivational Interview | SF-36v Social Functioning Scale | -16.67 units on a scale | Standard Deviation 40.18 |
| Usual Care | SF-36v Social Functioning Scale | -10.42 units on a scale | Standard Deviation 18.4 |