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Coordinating Center for Caregiver Intervention Trial (REACH)

Primary Purpose

Dementia, Alzheimer Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
multicomponent psychosocial intervention
Control arm
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dementia focused on measuring Family Caregivers, Dementia, Alzheimer Disease, Randomized Controlled Trial, Intervention Studies

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Caregiver Inclusion/Exclusion Criteria: Inclusion Criteria: Age: 21 years or older Family member of the care recipient Must live with care recipient or share cooking facilities Must have a telephone that will enable use of CTIS (Computer Telephone Integration System) system Must plan to remain in the recruitment area for the duration of the intervention and follow-up Caregiver role for more than 6 months Must provide on average 4 hours of supervision or direct assistance per day for the care recipient Risk Screening Tool: must have a total score of at least 1 for questions 1-3, and a total of at least 2 for questions 4-9 Exclusion Criteria: Non-English, non-Spanish speaking Active treatment (chemotherapy, radiation therapy) for cancer Imminent placement of care recipient into a nursing home or with another caregiver (within 6 months) Involvement in another clinical trial for caregivers Participant in REACH I study SPMSQ:> or = 4 errors* If the caregiver has been inconsistent with answers or repeated answers during the screening process, then the interviewer administers the Short Portable Mental Status Questionnaire (SPMSQ). If the caregiver missed 4 or more questions, he/she was excluded from the study. Care Recipient Inclusion/Exclusion Criteria Inclusion Criteria: a. NINCDS (MD diagnosis) of dementia or cognitive impairment (raw score on MMSE of 23 or less) Exclusion Criteria: Non-English, non-Spanish speaking History of Parkinson's Disease or a stroke with no reported decline in memory over the past year Active treatment (chemotherapy, radiation therapy) for cancer More than three acute medical hospitalizations in past year (other than psychiatric or Alzheimer's Disease related admission) Schizophrenia (onset of delusions before age 45) or other severe mental illness Dementia secondary to head trauma (probable) Blindness or deafness if either disability prohibits them from completion of data collection or participation in the interventions MMSE = 0 and Bedbound (confined to a bed or chair for >22 hours per day, for at least 4 of the past 7 days) Planned nursing home admission in 6 months Participant in REACH I study

Sites / Locations

  • University of Alabama at Birmingham
  • Stanford University and Veterans Affairs
  • University of Miami at Miami, Center on Adult Development and Aging
  • Thomas Jefferson University at Philadelphia, Center for Applied Research on Aging and Health
  • University of Tennessee Health Science Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Treatment

Control

Arm Description

The intervention addressed caregiver depression, burden, self-care, and social support and care recipient problem behaviors through 12 in-home and telephone sessions over 6 months.

Caregivers in the control group received 2 brief "check-in" telphone calls during the 6 month intervention.

Outcomes

Primary Outcome Measures

multivariate quality of life indicator- assessed caregiver burden, depressive symptoms, self-care, social support and patient problem behaviors. Assessed at six months post-randomization.

Secondary Outcome Measures

Caregiver clinical depression and patient institutional placement-six months post-randomization.

Full Information

First Posted
September 12, 2005
Last Updated
January 4, 2016
Sponsor
University of Pittsburgh
Collaborators
National Institute on Aging (NIA), National Institute of Nursing Research (NINR)
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1. Study Identification

Unique Protocol Identification Number
NCT00177489
Brief Title
Coordinating Center for Caregiver Intervention Trial
Acronym
REACH
Official Title
Coordinating Center for Multisite Intervention Trial for Diverse Caregivers
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
June 2002 (undefined)
Primary Completion Date
September 2005 (Actual)
Study Completion Date
September 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh
Collaborators
National Institute on Aging (NIA), National Institute of Nursing Research (NINR)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The primary goal of this study is to test a single multi-component intervention among family caregivers of persons with Alzheimer's disease or related disorders. The overall objectives of study are to 1) identify and reduce modifiable risk factors among diverse family caregivers of patients with Alzheimer's Disease or a related disorder, 2) enhance the quality of care of the care recipients, and 3) enhance the well-being of the caregivers.
Detailed Description
The proposed Coordinating Center (CC) will work with five sites and staff from the National Institute on Aging (NIA) and the National Institute of Nursing Research (NINR) to implement a multi-site caregiver intervention trial. The overall objective of this research program is to refine and test a multicomponent psychosocial intervention to reduce burden and depression among family caregivers of persons with Alzheimer's Disease or a related disorder. This competing renewal will build upon results obtained from its parent multi-site feasibility study, Resources for Enhancing Alzheimer's Caregiver Health (REACH) funded by the NIA/NINR as a cooperative agreement (UO1-AG13305). In the study proposed here, five intervention sites (Birmingham, Memphis, Miami, Palo Alto, and Philadelphia) will recruit 600 (120 per site) caregiver-care recipient dyads consisting of equal numbers of African Americans/Blacks, Hispanics/Latinos, and Caucasians/Whites. Caregivers will be randomized to either an in-home multicomponent intervention condition or a standardized information-only control condition. The Coordinating Center at the University of Pittsburgh will work with the intervention site investigators and the NIA/NINR to support the implementation of the intervention study at each site and to collect and analyze a common database across sites.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia, Alzheimer Disease
Keywords
Family Caregivers, Dementia, Alzheimer Disease, Randomized Controlled Trial, Intervention Studies

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
613 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Description
The intervention addressed caregiver depression, burden, self-care, and social support and care recipient problem behaviors through 12 in-home and telephone sessions over 6 months.
Arm Title
Control
Arm Type
Other
Arm Description
Caregivers in the control group received 2 brief "check-in" telphone calls during the 6 month intervention.
Intervention Type
Behavioral
Intervention Name(s)
multicomponent psychosocial intervention
Intervention Description
The intervention addressed caregiver depression, burden, self-care, and social support and care recipient problem behaviors through 12 in-home and telephone sessions over 6 months.
Intervention Type
Other
Intervention Name(s)
Control arm
Intervention Description
Caregivers in the control group received 2 brief "check-in" telephone calls during the 6-month intervention.
Primary Outcome Measure Information:
Title
multivariate quality of life indicator- assessed caregiver burden, depressive symptoms, self-care, social support and patient problem behaviors. Assessed at six months post-randomization.
Time Frame
six months
Secondary Outcome Measure Information:
Title
Caregiver clinical depression and patient institutional placement-six months post-randomization.
Time Frame
six months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Caregiver Inclusion/Exclusion Criteria: Inclusion Criteria: Age: 21 years or older Family member of the care recipient Must live with care recipient or share cooking facilities Must have a telephone that will enable use of CTIS (Computer Telephone Integration System) system Must plan to remain in the recruitment area for the duration of the intervention and follow-up Caregiver role for more than 6 months Must provide on average 4 hours of supervision or direct assistance per day for the care recipient Risk Screening Tool: must have a total score of at least 1 for questions 1-3, and a total of at least 2 for questions 4-9 Exclusion Criteria: Non-English, non-Spanish speaking Active treatment (chemotherapy, radiation therapy) for cancer Imminent placement of care recipient into a nursing home or with another caregiver (within 6 months) Involvement in another clinical trial for caregivers Participant in REACH I study SPMSQ:> or = 4 errors* If the caregiver has been inconsistent with answers or repeated answers during the screening process, then the interviewer administers the Short Portable Mental Status Questionnaire (SPMSQ). If the caregiver missed 4 or more questions, he/she was excluded from the study. Care Recipient Inclusion/Exclusion Criteria Inclusion Criteria: a. NINCDS (MD diagnosis) of dementia or cognitive impairment (raw score on MMSE of 23 or less) Exclusion Criteria: Non-English, non-Spanish speaking History of Parkinson's Disease or a stroke with no reported decline in memory over the past year Active treatment (chemotherapy, radiation therapy) for cancer More than three acute medical hospitalizations in past year (other than psychiatric or Alzheimer's Disease related admission) Schizophrenia (onset of delusions before age 45) or other severe mental illness Dementia secondary to head trauma (probable) Blindness or deafness if either disability prohibits them from completion of data collection or participation in the interventions MMSE = 0 and Bedbound (confined to a bed or chair for >22 hours per day, for at least 4 of the past 7 days) Planned nursing home admission in 6 months Participant in REACH I study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Schulz, Ph.D.
Organizational Affiliation
Professor of Psychiatry and Director, University Center for Social and Urban Research, University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294-2041
Country
United States
Facility Name
Stanford University and Veterans Affairs
City
Menlo Park
State/Province
California
ZIP/Postal Code
94025
Country
United States
Facility Name
University of Miami at Miami, Center on Adult Development and Aging
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Thomas Jefferson University at Philadelphia, Center for Applied Research on Aging and Health
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
University of Tennessee Health Science Center
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38163
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
There is no plan to make individual participant data available.
Citations:
PubMed Identifier
17116917
Citation
Belle SH, Burgio L, Burns R, Coon D, Czaja SJ, Gallagher-Thompson D, Gitlin LN, Klinger J, Koepke KM, Lee CC, Martindale-Adams J, Nichols L, Schulz R, Stahl S, Stevens A, Winter L, Zhang S; Resources for Enhancing Alzheimer's Caregiver Health (REACH) II Investigators. Enhancing the quality of life of dementia caregivers from different ethnic or racial groups: a randomized, controlled trial. Ann Intern Med. 2006 Nov 21;145(10):727-38. doi: 10.7326/0003-4819-145-10-200611210-00005.
Results Reference
result
PubMed Identifier
21391405
Citation
Nichols LO, Martindale-Adams J, Burns R, Graney MJ, Zuber J. Typical and atypical dementia family caregivers: systematic and objective comparisons. Int J Aging Hum Dev. 2011;72(1):27-43. doi: 10.2190/AG.72.1.b.
Results Reference
derived
PubMed Identifier
20122038
Citation
Elliott AF, Burgio LD, Decoster J. Enhancing caregiver health: findings from the resources for enhancing Alzheimer's caregiver health II intervention. J Am Geriatr Soc. 2010 Jan;58(1):30-7. doi: 10.1111/j.1532-5415.2009.02631.x.
Results Reference
derived
Links:
URL
http://www.edc.gsph.pitt.edu/reach2
Description
REACH II website- click here for more information about this study

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Coordinating Center for Caregiver Intervention Trial

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