- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00926848
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
Completed
Conditions
Intervention / Treatment
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
Enrollment (Actual)
68
Phase
- 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
-
-
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
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 |
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:
|
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:
Partners participated in the 18 educational sessions only. |
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
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
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
Collaborators
Investigators
- 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)
July 1, 2009
Primary Completion (Actual)
June 1, 2012
Study Completion (Actual)
June 1, 2012
Study Registration Dates
First Submitted
June 22, 2009
First Submitted That Met QC Criteria
June 23, 2009
First Posted (Estimated)
June 24, 2009
Study Record Updates
Last Update Posted (Actual)
September 25, 2023
Last Update Submitted That Met QC Criteria
September 13, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID 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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