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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by University of Nebraska.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Information provided by:
University of Nebraska
ClinicalTrials.gov Identifier:
NCT00926848
First received: June 22, 2009
Last updated: January 11, 2010
Last verified: January 2010
  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

Resource links provided by NLM:


Further study details as provided by University of Nebraska:

Primary Outcome Measures:
  • 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)
Intervention Details:
    Behavioral: Partners Together in Health (PaTH) Intervention
    Both partners actively participate in comprehensive CR and the usual care group where only the patient participates in CR and the partner is invited to attend the educational sessions with the patient. The CR activities that patients in both groups and partners in the intervention group will be provided with will be the same and are based on the clinical practice guidelines of the core components of CR. These components are: 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.
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, 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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00926848

Contacts
Contact: Bernice Yates, PhD 402-559-5460 bcyates@unmc.edu
Contact: Karin E Ashley, BSN 402-559-2268 keashley@unmc.edu

Locations
United States, Nebraska
University of Nebraska Medical Center Recruiting
Omaha, Nebraska, United States, 68198
Sub-Investigator: Scott Shurmur, MD         
Sponsors and Collaborators
University of Nebraska
Investigators
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 August 18, 2014