Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT00572988 |
| Other study ID # |
0528-01-FB |
| Secondary ID |
R01NR007759 |
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
May 1, 2002 |
| Est. completion date |
January 1, 2007 |
Study information
| Verified date |
August 2023 |
| Source |
University of Nebraska |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
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.
