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

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ClinicalTrials.gov Identifier: NCT00926848
Recruitment Status : Completed
First Posted : June 24, 2009
Results First Posted : June 20, 2018
Last Update Posted : June 20, 2018
Sponsor:
Collaborator:
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
Bernice Yates, 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.

Condition or disease Intervention/treatment Phase
Coronary Heart Disease Cardiac Rehabilitation Behavioral: Partners Together in Health (PaTH) Intervention Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Parallel 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.
Masking: Single (Outcomes Assessor)
Masking Description: The research personnel who were collecting outcomes data were unaware of the subjects' group assignment.
Primary Purpose: Treatment
Official Title: Reducing Risk in Cardiac Rehabilitation: Partners Together in Health (PaTH) Intervention Study
Study Start Date : July 2009
Actual Primary Completion Date : June 2012
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: PaTH intervention group

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.
Behavioral: Partners 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.

Active Comparator: Usual care group

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.

Behavioral: Partners 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.




Primary Outcome Measures :
  1. Healthy Lifestyle Behavior Was Physical Activity/Exercise in Patients [ Time Frame: 6 months post enrollment/baseline ]
    Physical activity/exercise behavior was measured using an Actigraph accelerometer at 6 months.

  2. Healthy Lifestyle Behavior Was Physical Activity/Exercise in Partners [ Time Frame: 6 months post enrollment/baseline ]
    Physical activity/exercise behavior was measured using an Actigraph accelerometer at 6 months.

  3. Eating Behavior (% Saturated Fat) in Patients [ Time Frame: 6 months post baseline ]
    Eating behavior (% saturated fat) was measured using a 3-day food record.

  4. Eating Behavior (% Saturated Fat) in Partners [ Time Frame: 6 months post baseline ]
    Eating behavior (% saturated fat) was measured using a 3-day food record.


Secondary Outcome Measures :
  1. Functional Capacity in Patients [ Time Frame: 6 months post baseline ]
    Exercise tolerance test using a treadmill

  2. Functional Capacity in Partners [ Time Frame: 6 months post baseline ]
    Exercise tolerance test using a treadmill



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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00926848


Locations
United States, Nebraska
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
Sponsors and Collaborators
University of Nebraska
National Institute of Nursing Research (NINR)
Investigators
Principal Investigator: Bernice Yates, PhD University of Nebraska Medical Center College of Nursing

Responsible Party: Bernice Yates, Principal Investigator, University of Nebraska
ClinicalTrials.gov Identifier: NCT00926848     History of Changes
Other Study ID Numbers: 544-08
1R15NR010923-01A1 ( U.S. NIH Grant/Contract )
First Posted: June 24, 2009    Key Record Dates
Results First Posted: June 20, 2018
Last Update Posted: June 20, 2018
Last Verified: May 2018

Keywords provided by Bernice Yates, University of Nebraska:
coronary heart disease
cardiac rehabilitation
lifestyle change
coronary artery bypass graft
social support
social cognitive learning theory

Additional relevant MeSH terms:
Heart Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases