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

September 13, 2023 updated by: University of Nebraska
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
68

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Nebraska
      • Omaha, Nebraska, United States, 68198
        • University Of Nebraska Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
6 months post enrollment/baseline
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.
6 months post enrollment/baseline
Eating Behavior (% Saturated Fat) in Patients
Time Frame: 6 months post baseline
Eating behavior (% saturated fat) was measured using a 3-day food record.
6 months post baseline
Eating Behavior (% Saturated Fat) in Partners
Time Frame: 6 months post baseline
Eating behavior (% saturated fat) was measured using a 3-day food record.
6 months post baseline

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Functional Capacity in Patients
Time Frame: 6 months post baseline
Exercise tolerance test using a treadmill
6 months post baseline
Functional Capacity in Partners
Time Frame: 6 months post baseline
Exercise tolerance test using a treadmill
6 months post baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Nebraska

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Nursing Research (NINR)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Bernice C Yates, PhD, University of Nebraska

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 22, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 23, 2009

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 24, 2009

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 25, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 13, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 0544-08-FB
  • 1R15NR010923-01A1 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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