CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 421 enrolled
Drug / intervention
Care Project for Hospitalized Elders & Family Caregivers +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00178412
NCT00178412Phase 2Completed

Improving Outcomes of Hospitalized Elders and Caregivers

University of Rochester·interventional·Posted Sep 15, 2005·Updated Jun 14, 2012

In Brief

A Phase 2 clinical trial evaluating Care Project for Hospitalized Elders & Family Caregivers and Comparison Group for Acute Illness. Completed, enrolled 421 participants across 1 site.

Detailed 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: 1. 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. 2. 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). 3. 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Illness
CountriesUnited States

Timeline

Phase 2CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 15, 2005
Enrollment StartApr 1, 2003
Primary CompletionApr 1, 2006
Study CompletionMar 1, 2009
TodayJul 2, 2026
Enrollment to primary: 3 yearsPosted 20.8 years ago

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

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.