Ignite Creation Date:
2024-05-05 @ 11:55 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00178412
Status:
COMPLETED
Last Update Posted:
2012-06-14
First Post:
2005-09-12
Brief Title:
Improving Outcomes of Hospitalized Elders and Caregivers
Sponsor:
University of Rochester
Organization:
University of Rochester
Study Overview
Official Title:
Improving Outcomes of Hospitalized Elders and Caregivers
Status:
COMPLETED
Status Verified Date:
2012-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 ones 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 ones care during hospitalization and 4 More positive role outcomes more role reward less role strain more prepared for their loved ones 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 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 ones 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 ones care during hospitalization and 4 More positive role outcomes more role reward less role strain more prepared for their loved ones 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
Detailed Description:
More than 12 million elderly people are hospitalized each year in the United Status frequently resulting in functional decline Family care of hospitalized elders is important given the increasing numbers of hospitalized elders needs for elder care in the home after hospital discharge and responsibilities of family caregivers for providing this care Involving family caregivers in the hospital care of their loved one may result in positive outcomes for both the elderly patients and their family caregivers However there is a paucity of empirical studies that have been conducted to evaluate the effectiveness of interventions to enhance family participation in caring for hospitalized elders In the proposed study we will build upon our prior work that has demonstrated the positive effects of theoretically-driven interventions with families of hospitalized patients and older adults at home Among the unique contributions of this study include a a randomized controlled design b testing of a theoretically-driven reproducible intervention that can be easily translated into clinical practice and widely disseminated c the testing of an explanatory model to explain the effects of the intervention d a prospective cost-effectiveness analysis and e an intervention that begins early in the hospital stay and f measurement of both short- and more long-term outcomes up to 2 months following hospital discharge
The primary aim of this study is to evaluate the effects of a theoretically-driven reproducible intervention CARE Creating Avenues for Relative Empowerment on the process and outcomes of hospitalized elders and their family caregivers The secondary aims are to a explore what factors moderate the effects of the intervention program eg social economic status and family preferences for care participation and b determine the cost-effectiveness of the CARE program A two-group experiment will be used with 280 family caregivers of hospitalized elders Measures of both process and outcome variables will be included such as family caregiver beliefs anxiety worry depression role outcomes as well as elderly patients outcomes during hospitalization and after hospital discharge Findings from a recent pilot study with 49 family caregiver-elders dyads support undertaking this full-scale clinical trial in that family caregivers who received the CARE program versus those who received a comparison program had more positive coping and role outcomes and their hospitalized elderly relatives had positive outcomes during and after hospitalization
The primary aim of this study is to evaluate the effects of a theoretically-driven reproducible intervention CARE Creating Avenues for Relative Empowerment on the process and outcomes of hospitalized elders and their family caregivers The secondary aims are to a explore what factors moderate the effects of the intervention program eg social economic status and family preferences for care participation and b determine the cost-effectiveness of the CARE program A two-group experiment will be used with 280 family caregivers of hospitalized elders Measures of both process and outcome variables will be included such as family caregiver beliefs anxiety worry depression role outcomes as well as elderly patients outcomes during hospitalization and after hospital discharge Findings from a recent pilot study with 49 family caregiver-elders dyads support undertaking this full-scale clinical trial in that family caregivers who received the CARE program versus those who received a comparison program had more positive coping and role outcomes and their hospitalized elderly relatives had positive outcomes during and after hospitalization
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01NR008455 | NIH | None | httpsreporternihgovquickSearchR01NR008455 |