NCT00178412

Brief Summary

In this study, an intervention is tested that is designed to improve the outcomes of hospitalized elders and family caregivers. Study design:

  • randomized, controlled study
  • participants: 280 family caregivers aged 21 or above
  • length of follow-up: 2 weeks and 2 months after hospitalization Study hypothesis: In this randomized clinical trial, the following hypotheses will be tested:
  • Hospitalized elders whose family CGs receive the CARE program versus those who receive a comparison program will have better outcomes during and after hospitalization as measured by: (1) fewer incidents of dysfunctional syndrome; (2) shorter hospital stays; (3) lower readmission rates; (4) less depressive symptoms; (5) higher cognitive level; (6) less functional decline perceived by family CG; and (7) a closer relationship with their family CGs.
  • Family CGs of hospitalized elders who receive the CARE program will report: (1) More positive beliefs about their loved one's responses to hospitalization and their role in the hospital setting; (2) more positive emotional outcomes (less worry, anxiety, and depressive symptoms) during and after hospitalization; (3) More participation in their loved one's care during hospitalization; and (4) More positive role outcomes (more role reward, less role strain, more prepared for their loved one's care, and a closer relationship with their elderly relatives, both during and after hospitalization).
  • The proposed model to explain the effects of the CARE program on the process and outcomes of family CG coping and elderly patient outcomes will be supported for CGs and elderly patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
421

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Apr 2003

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

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

April 1, 2003

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2006

Completed
2.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
Last Updated

June 14, 2012

Status Verified

June 1, 2012

Enrollment Period

3 years

First QC Date

September 12, 2005

Last Update Submit

June 13, 2012

Conditions

Acute Illness

Keywords

Hospitalized eldersFamily caregiversAcute care

Outcome Measures

Primary Outcomes (2)

  • Patients' outcomes: rates of dysfunctional syndrome, readmission rate, and depression.

    At intake, 1-3 days pre-hospital discharge, at 2 weeks and at 2 months post hospital discharge

  • Family Caregiver: emotional coping (worry, anxiety and depression); functional coping (participation in patient's care); and role outcomes(role reward, role strain)

    1-3 days pre-hospital discharge, at 2 weeks and at 2 months post hospital discharge

Secondary Outcomes (1)

  • Cost analysis.

    At intake, 1-3 days pre-hospital discharge, at 2 weeks and at 2 months post hospital discharge

Study Arms (2)

1

EXPERIMENTAL

Treatment group

Behavioral: Care Project for Hospitalized Elders & Family Caregivers

2

ACTIVE COMPARATOR

Comparison Group

Behavioral: Comparison Group

Interventions

Care Project for Hospitalized Elders & Family CaregiversBEHAVIORAL

Phase 1 in-hospital contact: Family caregivers complete baseline data, listen to a tape about helping the elderly relative cope with hospitalization, and work on a mutual agreement/identification of goals for participation in family member's hospital care (i.e., selection of two complications to focus on based on patient's illness condition) Phase 2 pre-hospital discharge: Family caregivers listen to a second tape about coping with the hospital experience, participating in their family member's in-hospital care, and preparing for hospital discharge/transition to home

1
Comparison GroupBEHAVIORAL

Phase 1 in-hospital contact: Family caregivers complete baseline data and listen to an informational tape about hospital policies. Phase 2 pre-hospital discharge: Family caregivers listen to a second informational tape about the hospital and medical center.

2

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age of 21 years or above;
  • have an elderly relative (65 years or above) admitted to the three study units within the past 24-48 hours; (c) are related to the patient by blood, marriage, adoption, or affinity as a significant other (e.g., life partner, close friend);
  • are primary CGs;
  • can read and speak English; and
  • live within a 1-hour drive of the facility (60 miles).

You may not qualify if:

  • paid care providers;
  • unable to complete the questionnaires or provide care because of their own mental or physical impairment;
  • Patient:
  • dies during the hospital stay or within 2 months after discharge;
  • is transferred from the Intensive Care Unit (ICU) and stayed in the ICU for more than 2 nights;
  • is diagnosed with dementia;
  • is admitted from a long-term care facility; and
  • is hospitalized for longer than 30 days
  • is staying longer than 6 weeks in a nursing home immediately after hospitalization.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Rochester School of Nursing

Rochester, New York, 14642, United States

Location

Related Publications (5)

  • Li H, Melnyk BM, McCann R. Review of intervention studies of families with hospitalized elderly relatives. J Nurs Scholarsh. 2004;36(1):54-9. doi: 10.1111/j.1547-5069.2004.04011.x.

    PMID: 15098419BACKGROUND

  • Li H, Melnyk BM, McCann R, Chatcheydang J, Koulouglioti C, Nichols LW, Lee MD, Ghassemi A. Creating avenues for relative empowerment (CARE): a pilot test of an intervention to improve outcomes of hospitalized elders and family caregivers. Res Nurs Health. 2003 Aug;26(4):284-99. doi: 10.1002/nur.10091.

    PMID: 12884417BACKGROUND

  • Li H. Family caregivers' preferences in caring for their hospitalized elderly relatives. Geriatr Nurs. 2002 Jul-Aug;23(4):204-7. doi: 10.1067/mgn.2002.126966.

    PMID: 12183745BACKGROUND

  • Li H. Hospitalized elders and family caregivers: a typology of family worry. J Clin Nurs. 2005 Jan;14(1):3-8. doi: 10.1111/j.1365-2702.2004.01013.x.

    PMID: 15656842RESULT

  • Li H. Identifying family care process themes in caring for their hospitalized elders. Appl Nurs Res. 2005 May;18(2):97-101. doi: 10.1016/j.apnr.2004.06.015.

    PMID: 15991107RESULT

MeSH Terms

Interventions

Caregivers

Intervention Hierarchy (Ancestors)

Health PersonnelHealth Care Facilities Workforce and Services

Study Officials

  • Hong Li, Ph.D., RN

    University of Rochester School of Nursing

    PRINCIPAL INVESTIGATOR

  • Bethel A Powers, RN, PhD

    University of Rochester School of Nursing

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 15, 2005

Study Start

April 1, 2003

Primary Completion

April 1, 2006

Study Completion

March 1, 2009

Last Updated

June 14, 2012

Record last verified: 2012-06

Locations

US(1)