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Symptom Management Intervention in Elderly Coronary Artery Bypass Patients
This study has been completed.
First Received: December 11, 2007   Last Updated: December 27, 2007   History of Changes
Sponsored by: University of Nebraska
Information provided by: University of Nebraska
ClinicalTrials.gov Identifier: NCT00572988
  Purpose

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.


Condition
Coronary Artery Disease

MedlinePlus related topics: Coronary Artery Bypass Surgery Coronary Artery Disease Palliative Care
U.S. FDA Resources
Study Type: Observational
Study Design: Prospective
Official Title: Symptom Management Intervention in Elderly CABG Patients

Further study details as provided by University of Nebraska:

Primary Outcome Measures:
  • Symptom Evaluation [ Time Frame: The duration of the study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Functional Status [ Time Frame: Duration of the study ] [ Designated as safety issue: No ]
  • Physical ACtivity [ Time Frame: Duration of the Study ] [ Designated as safety issue: No ]
  • Health Care Utilization [ Time Frame: 6 month follow up time period ] [ Designated as safety issue: No ]

Biospecimen Retention:   None Retained

Biospecimen Description:

Enrollment: 232
Study Start Date: May 2002
Study Completion Date: January 2007
Detailed Description:

Effective follow-up and management of elderly post-CABG patients is important in the overall recovery process. Specifically, this study will attempt to bridge the gap in current literature related to the impact of follow-up interventions to enhance recovery outcomes in the CABG population. 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 post- operatively. One group will receive the intervention and routine care (RC) and the other group will receive only RC. The major aim will be to determine if the intervention group will demonstrate: better physiological functioning (decreased symptom interference on physical functioning (decreased symptom interference on physical functioning; better scores on the SF 36 subscales: physical, role-physical and vitality, and increased activity and exercise energy expenditure); better physiological conditioning (decreased symptom interference on physical functioning; better scores on the SF 36 subscales; role-emotional, social, mental, and vitality); and fewer post-operative 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 level of functioning and care received)> In addition this study will examine the potential effects of mediating (evaluation of 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 above. The intervention will be delivered using a device called the Health Buddy that is attached to the patient's telephone line, able to download to a free secure Internet site daily, and cannot be used by health care providers for post-hospital follow up care. The 6- week SMHCNI was designed using Bandura's (1986) definition of self- efficacy which is to enhance the beliefs in ones capabilities to organize and execute the sources and actions required to manage prospective situations. Preliminary data have shown that these patients are going home with symptom management problems, but that complications arising from these problems might be prevented with early detection and management. Using a follow-up intervention such as the SMHCNI is expected to result in better functioning, management of symptoms and fewer post-operative problems. Also, a better understanding of HCU, patient satisfaction, and self-efficacy as variables will be described.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

Inclusion Criteria:

  • 65 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).

Exclusion Criteria:

  • None
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00572988

Sponsors and Collaborators
University of Nebraska
Investigators
Principal Investigator: Lani M Zimmerman University of Nebraska
  More Information

No publications provided

Responsible Party: University of Nebraska Medical Center ( Lani Zimmerman PI )
Study ID Numbers: IRB# 528-01-FB, RO1 NR07759
Study First Received: December 11, 2007
Last Updated: December 27, 2007
ClinicalTrials.gov Identifier: NCT00572988     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by University of Nebraska:
symptom management
function status
physical activity
health care utilization

Study placed in the following topic categories:
Arterial Occlusive Diseases
Coronary Disease
Heart Diseases
Myocardial Ischemia
Vascular Diseases
Arteriosclerosis
Ischemia
Coronary Artery Disease

Additional relevant MeSH terms:
Arterial Occlusive Diseases
Coronary Disease
Heart Diseases
Myocardial Ischemia
Vascular Diseases
Cardiovascular Diseases
Arteriosclerosis
Coronary Artery Disease

ClinicalTrials.gov processed this record on May 07, 2009