Reducing Risk in Cardiac Rehabilitation: Partners Together in Health (PaTH) Intervention Study

Not Applicable

Completed

Conditions: Coronary Heart Disease
Cardiac Rehabilitation

Interventions: Behavioral: Partners Together in Health (PaTH) Intervention

Registration Number: NCT00926848

Lead Sponsor: University of Nebraska

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 68

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).

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual care group	Partners Together in Health (PaTH) Intervention	The usual care group intervention for patients only consisted of participation in a structured and formal cardiac rehabilitation program: * 18-36 exercise sessions and 18 educational sessions Partners participated in the 18 educational sessions only.
PaTH intervention group	Partners Together in Health (PaTH) Intervention	The PaTH intervention group for patients and partners consisted of participation in a structured and formal cardiac rehabilitation program: * 18-36 exercise sessions * 18 educational sessions. The intervention consisted of patients and partners participating together in a formal cardiac rehabilitation program when typically just patients participate. In addition, partners were asked to make the same healthy eating and exercise changes that patients did to meet guidelines for health.

Primary Outcome Measures

Name	Time	Method
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.
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.

Secondary Outcome Measures

Name	Time	Method
Functional Capacity in Partners	6 months post baseline	Exercise tolerance test using a treadmill
Functional Capacity in Patients	6 months post baseline	Exercise tolerance test using a treadmill