Reducing Risk in Cardiac Rehabilitation: Partners Together in Health (PaTH) Intervention Study
Recruitment status was Recruiting
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Purpose
The objective of the proposed study, using an experimental, two-group (n = 30 couples in each group) repeated measures design, will be 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, b) functional capacity; c) quality of life (physical, psychological, and relational); and d) risk level for heart disease. The primary variables will be change in outcomes from baseline to 3 and 6 month time points in both the coronary artery bypass graft (CABG) patient and his/her partner.
| Condition | Intervention |
|---|---|
|
Coronary Heart Disease Cardiac Rehabilitation |
Behavioral: Partners Together in Health (PaTH) Intervention |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Reducing Risk in Cardiac Rehabilitation: Partners Together in Health (PaTH) Intervention Study |
- Healthy Lifestyle Behaviors. Healthy lifestyle behaviors in the proposed study are operationalized to include physical activity/exercise and dietary intake behaviors. [ Time Frame: 3, 6 months post enrollment ] [ Designated as safety issue: No ]
- Physical activity/exercise behavior.By pilot testing the feasibility of the PaTH intervention, important information will be obtained by which to gauge the feasibility of conducting a large scale clinical trial of the intervention. It is anticipated that [ Time Frame: 3, 6 months post enrollment ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 120 |
| Study Start Date: | July 2009 |
| Estimated Study Completion Date: | December 2010 |
| Estimated Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
-
Behavioral: Partners Together in Health (PaTH) Intervention
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, quality of life, and risk level for heart disease. 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 variables will be change in outcomes from baseline to 3 and 6 month time points in both the CABG patient and his/her partner. 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.
Eligibility| Ages Eligible for Study: | 19 Years and older |
| Genders Eligible for Study: | Both |
| Accepts 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).
Contacts and Locations| Contact: Bernice Yates, PhD | 402-559-5460 | bcyates@unmc.edu |
| Contact: Karin E Ashley, BSN | 402-559-2268 | keashley@unmc.edu |
| United States, Nebraska | |
| University of Nebraska Medical Center | Recruiting |
| Omaha, Nebraska, United States, 68198 | |
| Sub-Investigator: Scott Shurmur, MD | |
| Principal Investigator: | Bernice Yates, PhD | University of Nebraska Medical Center College of Nursing |
More Information
No publications provided
| Responsible Party: | Bernice Yates, PhD/Principal Investigator, University of Nebraska Medical Center College of Nursing |
| ClinicalTrials.gov Identifier: | NCT00926848 History of Changes |
| Other Study ID Numbers: | 544-08, 1R15NR010923-01A1 |
| Study First Received: | June 22, 2009 |
| Last Updated: | January 11, 2010 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Nebraska:
|
coronary heart disease cardiac rehabilitation lifestyle change |
coronary artery bypass graft social support social cognitive learning theory |
Additional relevant MeSH terms:
|
Coronary Artery Disease Myocardial Ischemia Coronary Disease Heart Diseases |
Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases |
ClinicalTrials.gov processed this record on May 19, 2013