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Completed

NCT Number: NCT00926848

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

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.

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Partners Together in Health (PaTH) Intervention

Behavioral

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Nebraska

Other

Collaborators

  • National Institute of Nursing Research (NINR)

Registry information

Acronym: PaTH

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Jun 24, 2009
Registry last updated
Sep 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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