Clinical trial NCT00572988: Symptom Management Intervention in Elderly Coronary Artery Bypass Patients
Official title: Symptom Management Intervention in Elderly CABG Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Keywords: symptom management
function status
physical activity
health care utilization
Lead sponsor: University of Nebraska
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2007-12-13
Enrollment: 232
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All subjects 65 and older who are admitted for a first time CABG surgery.

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.

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 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

Primary outcomes:
measure: Symptom Evaluation
timeFrame: The duration of the study
Secondary outcomes:
measure: Functional Status
timeFrame: Duration of the study
measure: Physical ACtivity
timeFrame: Duration of the Study
measure: Health Care Utilization
timeFrame: 6 month follow up time period
Other outcomes:
Locations:
Study officials:
affiliation: University of Nebraska
name: Lani M Zimmerman, PhD
role: PRINCIPAL_INVESTIGATOR
References: