Ignite Creation Date:
2024-05-05 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00178165
Status:
COMPLETED
Last Update Posted:
2005-09-15
First Post:
2005-09-13
Brief Title:
Coordinating Center for Enhancing ADRD Caregiving
Sponsor:
University of Pittsburgh
Organization:
University of Pittsburgh
Study Overview
Official Title:
Coordinating Center for Enhancing Alzheimer Disease and Related Disorder Caregiving
Status:
COMPLETED
Status Verified Date:
2005-09
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:
Established in 1995 Resources for Enhancing Alzheimers Caregiver Health REACH is a unique multi-site research program sponsored by the National Institute on Aging NIA and the National Institute on Nursing Research NINR The primary purpose of REACH is to carry out social and behavioral research on interventions designed to enhance family caregiving for Alzheimers disease and related disorders Specifically REACH has two goals to test the effectiveness of multiple different interventions and to evaluate the pooled effect of REACH interventions overall REACH grew out of a National Institute of Health NIH initiative that acknowledged the well-documented burdens associated with family caregiving as well as the existence of promising family caregiver interventions reported in the literature
Detailed Description:
Six sites Boston Birmingham Memphis Miami Palo Alto and Philadelphia developed and evaluated a variety of multi-component interventions for family caregivers of persons with Alzheimers Disease AD at the mild or moderate level of impairment The multi-component interventions implemented across the six sites included 1 Individual Information and Support strategies 2 Group Support and Family Systems therapy 3 Psychoeducational and Skill-based Training approaches 4 Home-based Environmental interventions and 5 Enhanced Technology Support Systems Although the interventions were derived from diverse theoretical models they are all consistent with basic health-stress models in which the goal is to change the nature of specific stressors eg problem behavior of the care recipient their appraisal andor the caregivers response to the stressors All of the REACH interventions were guided by detailed treatment manuals and certification procedures that assured that the interventions were delivered consistently over time at each site Careful attention was also paid to the issue of treatment integrity Different strategies were used at each site to induce and assess all three fundamental aspects of treatment integrity delivery receipt and enactment Burgio et al 2001 In addition because the caregiving experience in race and ethnic minority families is particularly neglected in the field there was a strong emphasis placed on the inclusion of African American and Hispanic caregivers Thus assessments as well as interventions were tailored at each site to meet the needs of culturally diverse racialethnic majority and minority populations
All of the REACH sites shared several common goals including 1 designing theory-driven caregiving interventions to test hypotheses about intervention processes and their effect on family caregivers 2 specifying intervention components that help us understand the pathways through which interventions produce desired outcomes 3 developing a standardized outcome protocol to assess the impact of different strategies on caregivers and their care recipients within each site and across sites and 4 creating a common database that would facilitate pooling data across sites In addition standard selection criteria were adopted by REACH
Although REACH has some of the features of a traditional multi-site randomized controlled clinical trial eg random assignment of participants to treatment and control conditions common database and outcome measures and identical measurement intervals across sites it differs on one key dimension-the interventions varied across sites REACH was designed to examine the feasibility and outcomes of multiple different intervention approaches rather than to provide definitive information on the efficacy of one specific intervention strategy for enhancing caregiver outcomes The strength of this approach is that it efficiently yields information about the effectiveness of different approaches to AD caregiving as well as the combined effects of active treatment versus controls as reported in the planned meta-analysis
REACH successfully randomized 1222 caregivercare recipient dyads representing both majority and minority populations to 15 different conditions
All of the REACH sites shared several common goals including 1 designing theory-driven caregiving interventions to test hypotheses about intervention processes and their effect on family caregivers 2 specifying intervention components that help us understand the pathways through which interventions produce desired outcomes 3 developing a standardized outcome protocol to assess the impact of different strategies on caregivers and their care recipients within each site and across sites and 4 creating a common database that would facilitate pooling data across sites In addition standard selection criteria were adopted by REACH
Although REACH has some of the features of a traditional multi-site randomized controlled clinical trial eg random assignment of participants to treatment and control conditions common database and outcome measures and identical measurement intervals across sites it differs on one key dimension-the interventions varied across sites REACH was designed to examine the feasibility and outcomes of multiple different intervention approaches rather than to provide definitive information on the efficacy of one specific intervention strategy for enhancing caregiver outcomes The strength of this approach is that it efficiently yields information about the effectiveness of different approaches to AD caregiving as well as the combined effects of active treatment versus controls as reported in the planned meta-analysis
REACH successfully randomized 1222 caregivercare recipient dyads representing both majority and minority populations to 15 different conditions
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 |
|---|---|---|---|
| AG13305 | None | None | None |
| NR13269 | None | None | None |
| AG13313 | None | None | None |
| AG13297 | None | None | None |
| AG13289 | None | None | None |
| AG13265 | None | None | None |
| AG13255 | None | None | None |