Cardiac Rehabilitation, Coronary Heart Disease
Conditions
Keywords
coronary heart disease, cardiac rehabilitation, lifestyle change, coronary artery bypass graft, social support, social cognitive learning theory
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALPartners Together in Health (PaTH) Intervention
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.
Sponsors
National Institute of Nursing Research (NINR)
University of Nebraska
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
The research personnel who were collecting outcomes data were unaware of the subjects' group assignment.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* age 19 or older * diagnosis of first-time coronary artery bypass graft surgery (CABGs) and enrollment in outpatient CR * married or living with partner for more than 1 year * partner is also willing to participate * no history of psychiatric illness * classified as low to moderate risk for the occurrence of cardiac events during exercise (AACVPR, 2004). * first-time CABG patients Eligible partners will: * be age 19 or older * have no history of psychiatric illness * be classified as low to moderate risk for the occurrence of cardiac events during exercise * have written permission from the partner's primary health care provider to participate in the study.
Exclusion criteria
* orthopedic problems that would prevent them from walking or exercising * history of cardiac arrest, sudden death, complex dysrhythmias at rest, or CHF diagnosis * resting systolic BP \> 200 mmHg or diastolic BP \> 100 mmHg * a concomitant diagnosis or procedure such as valve repair/replacement or aneurysmectomy * debilitating non-cardiac disease such as renal failure or anemia * severe chronic obstructive lung disease (FEV1 \< 1 liter) * poorly controlled diabetics (diagnosed with diabetic ketoacidosis within the past 6 months or a current HgA1c \> 11).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Healthy Lifestyle Behavior Was Physical Activity/Exercise in Patients | 6 months post enrollment/baseline | Physical activity/exercise behavior was measured using an Actigraph accelerometer at 6 months. |
| Healthy Lifestyle Behavior Was Physical Activity/Exercise in Partners | 6 months post enrollment/baseline | Physical activity/exercise behavior was measured using an Actigraph accelerometer at 6 months. |
| Eating Behavior (% Saturated Fat) in Patients | 6 months post baseline | Eating behavior (% saturated fat) was measured using a 3-day food record. |
| Eating Behavior (% Saturated Fat) in Partners | 6 months post baseline | Eating behavior (% saturated fat) was measured using a 3-day food record. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Functional Capacity in Patients | 6 months post baseline | Exercise tolerance test using a treadmill |
| Functional Capacity in Partners | 6 months post baseline | Exercise tolerance test using a treadmill |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| PaTH Intervention Group Patients and partners participated in 18-36 exercise and 18 educational sessions. | 34 |
| Usual Care Group Only patients participated in 18-36 exercise and 18 educational sessions. Partners only participated in educational sessions. | 34 |
| Total | 68 |
Baseline characteristics
| Characteristic | PaTH Intervention Group | Total | Usual Care Group |
|---|---|---|---|
| Age, Continuous | 61.7 years STANDARD_DEVIATION 10.3 | 60.4 years STANDARD_DEVIATION 12.2 | 59.5 years STANDARD_DEVIATION 14.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 4 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 32 Participants | 64 Participants | 32 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| 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 | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 34 Participants | 68 Participants | 34 Participants |
| Region of Enrollment United States | 34 participants | 68 participants | 34 participants |
| Sex: Female, Male Female | 17 Participants | 35 Participants | 18 Participants |
| Sex: Female, Male Male | 17 Participants | 33 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 32 | 0 / 32 |
| other Total, other adverse events | 1 / 32 | 0 / 32 |
| serious Total, serious adverse events | 0 / 32 | 0 / 32 |
Outcome results
Primary
Eating Behavior (% Saturated Fat) in Partners
Eating behavior (% saturated fat) was measured using a 3-day food record.
Time frame: 6 months post baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PaTH Intervention Group (Patients Only, n=17) | Eating Behavior (% Saturated Fat) in Partners | 10.6 percent saturated fat per day | Standard Deviation 2.3 |
| Usual Care Group (Patients Only, n=17) | Eating Behavior (% Saturated Fat) in Partners | 11.2 percent saturated fat per day | Standard Deviation 2.3 |
p-value: >0.05t-test, 2 sided
Primary
Eating Behavior (% Saturated Fat) in Patients
Eating behavior (% saturated fat) was measured using a 3-day food record.
Time frame: 6 months post baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PaTH Intervention Group (Patients Only, n=17) | Eating Behavior (% Saturated Fat) in Patients | 10.0 percent saturated fat per day | Standard Deviation 2.4 |
| Usual Care Group (Patients Only, n=17) | Eating Behavior (% Saturated Fat) in Patients | 10.3 percent saturated fat per day | Standard Deviation 2.6 |
p-value: >0.05t-test, 2 sided
Primary
Healthy Lifestyle Behavior Was Physical Activity/Exercise in Partners
Physical activity/exercise behavior was measured using an Actigraph accelerometer at 6 months.
Time frame: 6 months post enrollment/baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PaTH Intervention Group (Patients Only, n=17) | Healthy Lifestyle Behavior Was Physical Activity/Exercise in Partners | 45.0 minutes per day | Standard Deviation 4.6 |
| Usual Care Group (Patients Only, n=17) | Healthy Lifestyle Behavior Was Physical Activity/Exercise in Partners | 38.4 minutes per day | Standard Deviation 5.8 |
p-value: >0.05t-test, 2 sided
Primary
Healthy Lifestyle Behavior Was Physical Activity/Exercise in Patients
Physical activity/exercise behavior was measured using an Actigraph accelerometer at 6 months.
Time frame: 6 months post enrollment/baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PaTH Intervention Group (Patients Only, n=17) | Healthy Lifestyle Behavior Was Physical Activity/Exercise in Patients | 25.8 minutes per day | Standard Deviation 3.3 |
| Usual Care Group (Patients Only, n=17) | Healthy Lifestyle Behavior Was Physical Activity/Exercise in Patients | 21.8 minutes per day | Standard Deviation 3.4 |
p-value: >0.05t-test, 2 sided
Secondary
Functional Capacity in Partners
Exercise tolerance test using a treadmill
Time frame: 6 months post baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PaTH Intervention Group (Patients Only, n=17) | Functional Capacity in Partners | 10.3 Metabolic equivalents (METs) | Standard Deviation 1.8 |
| Usual Care Group (Patients Only, n=17) | Functional Capacity in Partners | 9.5 Metabolic equivalents (METs) | Standard Deviation 2 |
p-value: >0.05t-test, 2 sided
Secondary
Functional Capacity in Patients
Exercise tolerance test using a treadmill
Time frame: 6 months post baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PaTH Intervention Group (Patients Only, n=17) | Functional Capacity in Patients | 9.8 Metabolic equivalents (METs) | Standard Deviation 1.7 |
| Usual Care Group (Patients Only, n=17) | Functional Capacity in Patients | 9.5 Metabolic equivalents (METs) | Standard Deviation 1.9 |
p-value: >0.05t-test, 2 sided