NCT00572988

Brief Summary

The major purpose of this experimental study is to test the effects of the symptom management home care nursing intervention (SMHCNI) on recovery outcomes of elderly CABG patients, using a randomized, two group (n=284) repeated measures design with measurements at discharge, at 3 and 6 weeks, and 3 and 6 months postoperatively. One group will receive the intervention and routine care (RC) and the other group will receive RC only. The major aim will be to determine if the intervention group will demonstrate: better physiological functioning (decreased symptom interference on physical functioning; better scores on the SF36 subscales: physical, role-physical and vitality, and increased activity and exercise energy expenditure); better psychosocial functioning (decreased symptom interference on enjoyment of life; and better SF36 subscales; role-emotional, social, mental, and vitality); and fewer postoperative problems (e.g. infections, fluid in lungs, heart rate rhythm problems). Additional outcomes for secondary aims are: lower levels of health care utilization (HCU) (i.e., fewer number of visits to health care providers, fewer number of emergency department visits, fewer number of home health visits, fewer rehospitalizations); and higher patient satisfaction (with level of functioning and care received). In addition this study will examine the potential effects of mediating (evaluation of symptoms, and perceived self-efficacy), and moderating variables (participation in cardiac rehabilitation) with the intervention on outcomes identified.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
232

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2002

Longer than P75 for all trials

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2002

Completed
4.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2007

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

December 11, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 13, 2007

Completed
Last Updated

August 30, 2023

Status Verified

August 1, 2023

First QC Date

December 11, 2007

Last Update Submit

August 28, 2023

Conditions

Keywords

symptom managementfunction statusphysical activityhealth care utilization

Outcome Measures

Primary Outcomes (1)

  • Symptom Evaluation

    The duration of the study

Secondary Outcomes (3)

  • Functional Status

    Duration of the study

  • Physical ACtivity

    Duration of the Study

  • Health Care Utilization

    6 month follow up time period

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All subjects 65 and older who are admitted for a first time CABG surgery.

You may qualify if:

  • years of age or older and having undergone CABG surgery
  • Oriented to person, place, and time
  • Not visually impaired, able to hear, and able to speak and read English (eyeglasses and or hearing aids permitted)
  • Not eligible for home health care (would not be homebound or have a draining wound)
  • Have a phone with a non-rotary phone service
  • Discharged within 7 days after surgery
  • No physical impairments that would limit their physical functioning after surgery (e.g. stroke).

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Coronary Artery DiseaseMotor ActivityPatient Acceptance of Health Care

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesBehaviorTreatment Adherence and ComplianceHealth Behavior

Study Officials

  • Lani M Zimmerman, PhD

    University of Nebraska

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 11, 2007

First Posted

December 13, 2007

Study Start

May 1, 2002

Study Completion

January 1, 2007

Last Updated

August 30, 2023

Record last verified: 2023-08