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| ID | Type | Description | Link |
|---|---|---|---|
| 1R15NR010923-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Nursing Research (NINR) | NIH |
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The objective of the proposed study, using an experimental, two-group (n = 30 couples in each group) repeated measures design, was to pilot test the effects of the PaTH Intervention versus a usual care group in improving the following outcomes: a) physical activity and healthy eating behaviors, and b) functional capacity. The primary outcomes will be physical activity behavior (minutes per week) and eating behavior (percent saturated fat) at the 6 month time point in both the coronary artery bypass graft (CABG) patient and his/her partner. Secondary outcome includes functional capacity in patients and partners at 6 months.
Long-term maintenance of lifestyle changes to reduce cardiovascular risk factors after coronary artery bypass graft (CABG) surgery is essential to positively influence health outcomes. Despite proven efficacy of cardiac rehabilitation (CR) in helping patients initiate lifestyle changes, less than 50% of CABG patients maintain lifestyle changes by 6 months post-CABG. It is known that the spouse is the main source of social support for the recovering cardiac patient and frequently attends cardiac rehabilitation with the patient to provide transportation, emotional support, or attend educational classes. In spite of these supportive behaviors, however; adherence still drops off after CR. Lifestyle interventions that specifically target the marital partners as a unit may be more efficacious than current individually-oriented education strategies. The objective of the proposed feasibility study, using an experimental, two-group (n = 30 couples in each group) repeated measures design, will be to pilot test the effects of the Partners Together in Health (PaTH) Intervention versus usual care in improving physical activity and healthy eating behaviors, and functional capacity. The specific aims are to assess the feasibility of implementing the PaTH Intervention and generate pilot data on all outcome variables in both the CABG patient and the partner to estimate effect sizes needed to determine the sample size requirements for the larger study. Partners in the PaTH Intervention group will formally join CR with the patient to participate in exercise sessions and educational classes to undertake comprehensive risk reduction for themselves, and to make the same positive physical activity/exercise and healthy eating lifestyle changes as the patient. Partners in the usual care group will be invited to attend the educational sessions with the patient as is currently usual care. The primary outcomes will be physical activity behavior (minutes per week) and eating behavior (percent saturated fat) at the 6 month time point in both the coronary artery bypass graft (CABG) patient and his/her partner. The secondary outcome includes functional capacity in patients and partners at 6 months. The PaTH intervention is innovative because it allows the couple to build new habits together so they can motivate and support one another on their journey toward health, it uses an existing, well-established treatment method (cardiac rehab) to deliver cost-effective care (Balady et al., 2007), it provides self-efficacy and social support for both members of the dyad in making behavioral changes, and no other studies testing the effects of including the partner in CR were found.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PaTH intervention group | Experimental | The PaTH intervention group for patients and partners consisted of participation in a structured and formal cardiac rehabilitation program:
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| Usual care group | Active Comparator | The usual care group intervention for patients only consisted of participation in a structured and formal cardiac rehabilitation program:
Partners participated in the 18 educational sessions only. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Partners Together in Health (PaTH) Intervention | Behavioral | Patients and partners in the PaTH experimental group participated in 18-36 exercise and 18 educational sessions in a structured cardiac rehabilitation program. Patients in the Usual care group also participated in 18-36 exercise and 18 educational sessions; partners, however, only participated in the educational sessions. |
| Measure | Description | Time Frame |
|---|---|---|
| Healthy Lifestyle Behavior Was Physical Activity/Exercise in Patients | Physical activity/exercise behavior was measured using an Actigraph accelerometer at 6 months. | 6 months post enrollment/baseline |
| Healthy Lifestyle Behavior Was Physical Activity/Exercise in Partners | Physical activity/exercise behavior was measured using an Actigraph accelerometer at 6 months. | 6 months post enrollment/baseline |
| Eating Behavior (% Saturated Fat) in Patients | Eating behavior (% saturated fat) was measured using a 3-day food record. | 6 months post baseline |
| Eating Behavior (% Saturated Fat) in Partners | Eating behavior (% saturated fat) was measured using a 3-day food record. | 6 months post baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Functional Capacity in Patients | Exercise tolerance test using a treadmill | 6 months post baseline |
| Functional Capacity in Partners | Exercise tolerance test using a treadmill |
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Inclusion Criteria:
Eligible partners will:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bernice C Yates, PhD | University of Nebraska | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Nebraska Medical Center | Omaha | Nebraska | 68198 | United States |
One patient in the PaTH intervention group did not tolerate the baseline (T1) exercise treadmill test due to orthopedic problems. Thus, this couple was ineligible to continue in the study.
158 couples were assessed for eligibility; 87 couples did not meet inclusion criteria. Of the 72 eligible, 37 declined to participate. Of the 34 couples who consented, 17 couples (17 patients and 17 partners) were randomly allocated to the PaTH group and 17 couples (17 patients and 17 partners) to the usual care group = 68 individual participants.
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| ID | Title | Description |
|---|---|---|
| FG000 | Usual Care Group | In the usual care group, only patients received the full cardiac rehabilitation program consisting of comprehensive risk reduction, educational classes, and 3 exercise sessions per week for 8 weeks. Partners participated in the educational classes only. |
| FG001 | PaTH Intervention Group | Patients and partners in the PaTH intervention group formally joined and participated in the full cardiac rehabilitation (CR) program consisting of comprehensive risk reduction educational classes and 3 exercise sessions/week for 8 weeks. These CR components were: prescribed exercise, education about cardiac risk factor modification, and counseling about self-efficacy strategies that may be effective in assisting with initial lifestyle changes and in preventing and managing relapse. All patients and partners in CR will be provided with a comprehensive, individualized, multidisciplinary risk factor modification program focused on all of the person's risk factors for coronary heart disease. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | PaTH Intervention Group | Patients and partners participated in 18-36 exercise and 18 educational sessions. |
| BG001 | Usual Care Group | Only patients participated in 18-36 exercise and 18 educational sessions. Partners only participated in educational sessions. |
| 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 | Healthy Lifestyle Behavior Was Physical Activity/Exercise in Patients | Physical activity/exercise behavior was measured using an Actigraph accelerometer at 6 months. | Posted | Mean | Standard Deviation | minutes per day | 6 months post enrollment/baseline |
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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 | PaTH Intervention Group | Patients and partners in the PaTH intervention group formally joined and participated in the full cardiac rehabilitation (CR) program consisting of comprehensive risk reduction educational classes and 3 exercise sessions/week for 8 weeks. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| orthopedic pain | Musculoskeletal and connective tissue disorders | Systematic Assessment | Hip pain 3 days post exercise test |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bernice Yates | University of Nebraska Medical Center | 402-861-1713 | bcyates@unmc.edu |
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| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D006262 | Health |
| D008722 | Methods |
| ID | Term |
|---|---|
| D011154 | Population Characteristics |
| D008919 | Investigative Techniques |
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Patients and partners in the PaTH intervention group formally joined and participated in the full cardiac rehabilitation (CR) program consisting of 18-36 exercise and 18 educational sessions. In the usual care group, only patients received the exercise and educational sessions; partners received the educational sessions only.
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The research personnel who were collecting outcomes data were unaware of the subjects' group assignment.
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| 6 months post baseline |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | 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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| Primary | Healthy Lifestyle Behavior Was Physical Activity/Exercise in Partners | Physical activity/exercise behavior was measured using an Actigraph accelerometer at 6 months. | Posted | Mean | Standard Deviation | minutes per day | 6 months post enrollment/baseline |
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| Primary | Eating Behavior (% Saturated Fat) in Patients | Eating behavior (% saturated fat) was measured using a 3-day food record. | Posted | Mean | Standard Deviation | percent saturated fat per day | 6 months post baseline |
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| Primary | Eating Behavior (% Saturated Fat) in Partners | Eating behavior (% saturated fat) was measured using a 3-day food record. | Posted | Mean | Standard Deviation | percent saturated fat per day | 6 months post baseline |
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| Secondary | Functional Capacity in Patients | Exercise tolerance test using a treadmill | Posted | Mean | Standard Deviation | Metabolic equivalents (METs) | 6 months post baseline |
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| Secondary | Functional Capacity in Partners | Exercise tolerance test using a treadmill | Posted | Mean | Standard Deviation | Metabolic equivalents (METs) | 6 months post baseline |
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| 0 |
| 32 |
| 0 |
| 32 |
| 1 |
| 32 |
| EG001 | Usual Care Group | In the usual care group, only patients received the full cardiac rehabilitation program consisting of comprehensive risk reduction, educational classes, and 3 exercise sessions per week for 8 weeks. Partners participated in the educational classes only. | 0 | 32 | 0 | 32 | 0 | 32 |
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