search
Back to results

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

Primary Purpose

Coronary Heart Disease, Cardiac Rehabilitation

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Partners Together in Health (PaTH) Intervention
Sponsored by
University of Nebraska
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Heart Disease focused on measuring coronary heart disease, cardiac rehabilitation, lifestyle change, coronary artery bypass graft, social support, social cognitive learning theory

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

  • University of Nebraska Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

PaTH intervention group

Usual care group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Healthy Lifestyle Behavior Was Physical Activity/Exercise in Patients
Physical activity/exercise behavior was measured using an Actigraph accelerometer at 6 months.
Healthy Lifestyle Behavior Was Physical Activity/Exercise in Partners
Physical activity/exercise behavior was measured using an Actigraph accelerometer at 6 months.
Eating Behavior (% Saturated Fat) in Patients
Eating behavior (% saturated fat) was measured using a 3-day food record.
Eating Behavior (% Saturated Fat) in Partners
Eating behavior (% saturated fat) was measured using a 3-day food record.

Secondary Outcome Measures

Functional Capacity in Patients
Exercise tolerance test using a treadmill
Functional Capacity in Partners
Exercise tolerance test using a treadmill

Full Information

First Posted
June 22, 2009
Last Updated
September 13, 2023
Sponsor
University of Nebraska
Collaborators
National Institute of Nursing Research (NINR)
search

1. Study Identification

Unique Protocol Identification Number
NCT00926848
Brief Title
Reducing Risk in Cardiac Rehabilitation: Partners Together in Health (PaTH) Intervention Study
Acronym
PaTH
Official Title
Reducing Risk in Cardiac Rehabilitation: Partners Together in Health (PaTH) Intervention Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
July 1, 2009 (Actual)
Primary Completion Date
June 1, 2012 (Actual)
Study Completion Date
June 1, 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Nebraska
Collaborators
National Institute of Nursing Research (NINR)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Heart Disease, Cardiac Rehabilitation
Keywords
coronary heart disease, cardiac rehabilitation, lifestyle change, coronary artery bypass graft, social support, social cognitive learning theory

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Outcomes Assessor
Masking Description
The research personnel who were collecting outcomes data were unaware of the subjects' group assignment.
Allocation
Randomized
Enrollment
68 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PaTH intervention group
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual care group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Partners Together in Health (PaTH) Intervention
Intervention Description
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 Measure Information:
Title
Healthy Lifestyle Behavior Was Physical Activity/Exercise in Patients
Description
Physical activity/exercise behavior was measured using an Actigraph accelerometer at 6 months.
Time Frame
6 months post enrollment/baseline
Title
Healthy Lifestyle Behavior Was Physical Activity/Exercise in Partners
Description
Physical activity/exercise behavior was measured using an Actigraph accelerometer at 6 months.
Time Frame
6 months post enrollment/baseline
Title
Eating Behavior (% Saturated Fat) in Patients
Description
Eating behavior (% saturated fat) was measured using a 3-day food record.
Time Frame
6 months post baseline
Title
Eating Behavior (% Saturated Fat) in Partners
Description
Eating behavior (% saturated fat) was measured using a 3-day food record.
Time Frame
6 months post baseline
Secondary Outcome Measure Information:
Title
Functional Capacity in Patients
Description
Exercise tolerance test using a treadmill
Time Frame
6 months post baseline
Title
Functional Capacity in Partners
Description
Exercise tolerance test using a treadmill
Time Frame
6 months post baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bernice C Yates, PhD
Organizational Affiliation
University of Nebraska
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs