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Coronary Artery DiseaseNCT00572988

Symptom Management Intervention in Elderly Coronary Artery Bypass Patients

An observational study of Coronary Artery Disease, run by University of Nebraska.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Coronary Artery Disease
How many people
232 participants
Where
No sites listed yet
Study dates
1 May 2002to 1 Jan 2007
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

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

Who may be able to join

  • 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).

Who cannot join

  • None

About this study

Official title: Symptom Management Intervention in Elderly CABG Patients

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.

Read the 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.

Keywords
symptom management, function status, physical activity, health care utilization
Medical subject headings
Coronary Artery Disease, Motor Activity, Patient Acceptance of Health Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Symptom Evaluation

    Measured: The duration of the study

Secondary outcomes (3)
  1. Functional Status

    Measured: Duration of the study

  2. Physical ACtivity

    Measured: Duration of the Study

  3. Health Care Utilization

    Measured: 6 month follow up time period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Dec 2007 (estimated)
  2. Study start1 May 2002
  3. Study completion1 Jan 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
232 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00572988
Sponsor's protocol ID
0528-01-FB
Other IDs
R01NR007759
Status last verified
Aug 2023
First submitted
11 Dec 2007
Last updated
30 Aug 2023
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Coronary Artery Disease, run by University of Nebraska.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Symptom Evaluation (time frame: The duration of the study). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2023.

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