NCT00926848

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 22, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 24, 2009

Completed
7 days until next milestone

Study Start

First participant enrolled

July 1, 2009

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
6.1 years until next milestone

Results Posted

Study results publicly available

June 20, 2018

Completed
Last Updated

September 25, 2023

Status Verified

September 1, 2023

Enrollment Period

2.9 years

First QC Date

June 22, 2009

Results QC Date

September 13, 2017

Last Update Submit

September 13, 2023

Conditions

Coronary Heart DiseaseCardiac Rehabilitation

Keywords

coronary heart diseasecardiac rehabilitationlifestyle changecoronary artery bypass graftsocial supportsocial cognitive learning theory

Outcome Measures

Primary Outcomes (4)

  • Healthy Lifestyle Behavior Was Physical Activity/Exercise in Patients

    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

    Physical activity/exercise behavior was measured using an Actigraph accelerometer at 6 months.

    6 months post enrollment/baseline

  • Eating Behavior (% Saturated Fat) in Patients

    Eating behavior (% saturated fat) was measured using a 3-day food record.

    6 months post baseline

  • Eating Behavior (% Saturated Fat) in Partners

    Eating behavior (% saturated fat) was measured using a 3-day food record.

    6 months post baseline

Secondary Outcomes (2)

  • Functional Capacity in Patients

    6 months post baseline

  • Functional Capacity in Partners

    6 months post baseline

Study Arms (2)

PaTH intervention group

EXPERIMENTAL

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

Usual care group

ACTIVE COMPARATOR

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

Interventions

Partners Together in Health (PaTH) InterventionBEHAVIORAL

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.

PaTH intervention groupUsual care group

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

MeSH Terms

Conditions

Coronary Disease

Interventions

HealthMethods

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Population CharacteristicsInvestigative Techniques

Results Point of Contact

Title
Bernice Yates
Organization
University of Nebraska Medical Center
bcyates@unmc.edu
402-861-1713

Study Officials

  • Bernice C Yates, PhD

    University of Nebraska

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The research personnel who were collecting outcomes data were unaware of the subjects' group assignment.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 22, 2009

First Posted

June 24, 2009

Study Start

July 1, 2009

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

September 25, 2023

Results First Posted

June 20, 2018

Record last verified: 2023-09

Locations

US(1)