REACH: Coordinating Center for Caregiver Intervention Trial

• Sponsor: University of Pittsburgh (Other)
• Overall Status: Completed
• CT.gov ID: NCT00177489
• Collaborator: National Institute on Aging (NIA) (NIH), National Institute of Nursing Research (NINR) (NIH)
• Enrollment: 613
• Locations: 5
• Arms: 2
• Duration (Months): 39
• Patients Per Site: 122.6
• Patients Per Site Per Month: 3.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Dementia; Alzheimer Disease	Behavioral: multicomponent psychosocial intervention; Other: Control arm	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 613 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Coordinating Center for Multisite Intervention Trial for Diverse Caregivers
• Study Start Date: Jun 1, 2002
• Actual Primary Completion Date: Sep 1, 2005
• Actual Study Completion Date: Sep 1, 2005

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment 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.	Behavioral: multicomponent psychosocial intervention; 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.
Other: Control Caregivers in the control group received 2 brief "check-in" telphone calls during the 6 month intervention.	Other: Control arm; Caregivers in the control group received 2 brief "check-in" telephone calls during the 6-month intervention.

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Caregiver Inclusion/Exclusion Criteria:

• Inclusion Criteria:

1. Age: 21 years or older

2. Family member of the care recipient

3. Must live with care recipient or share cooking facilities

4. Must have a telephone that will enable use of CTIS (Computer Telephone Integration System) system

5. Must plan to remain in the recruitment area for the duration of the intervention and follow-up

6. Caregiver role for more than 6 months

7. Must provide on average 4 hours of supervision or direct assistance per day for the care recipient

8. 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:

1. Non-English, non-Spanish speaking

2. Active treatment (chemotherapy, radiation therapy) for cancer

3. Imminent placement of care recipient into a nursing home or with another caregiver (within 6 months)

4. Involvement in another clinical trial for caregivers

5. Participant in REACH I study

6. 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:

1. NINCDS (MD diagnosis) of dementia or cognitive impairment (raw score on MMSE of 23 or less)

Exclusion Criteria:

1. Non-English, non-Spanish speaking

2. History of Parkinson's Disease or a stroke with no reported decline in memory over the past year

3. Active treatment (chemotherapy, radiation therapy) for cancer

4. More than three acute medical hospitalizations in past year (other than psychiatric or Alzheimer's Disease related admission)

5. Schizophrenia (onset of delusions before age 45) or other severe mental illness

6. Dementia secondary to head trauma (probable)

7. Blindness or deafness if either disability prohibits them from completion of data collection or participation in the interventions

8. MMSE = 0 and Bedbound (confined to a bed or chair for >22 hours per day, for at least 4 of the past 7 days)

9. Planned nursing home admission in 6 months

10. Participant in REACH I study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama at Birmingham	Birmingham	Alabama	United States	35294-2041
2	Stanford University and Veterans Affairs	Menlo Park	California	United States	94025
3	University of Miami at Miami, Center on Adult Development and Aging	Miami	Florida	United States	33136
4	Thomas Jefferson University at Philadelphia, Center for Applied Research on Aging and Health	Philadelphia	Pennsylvania	United States	19107
5	University of Tennessee Health Science Center	Memphis	Tennessee	United States	38163

Sponsors and Collaborators

• University of Pittsburgh
• National Institute on Aging (NIA)
• National Institute of Nursing Research (NINR)

Investigators

• Principal Investigator: Richard Schulz, Ph.D., Professor of Psychiatry and Director, University Center for Social and Urban Research, University of Pittsburgh

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• REACH II website- click here for more information about this study

Publications

None provided.

• Responsible Party: Richard Schulz, Professor of Psychiatry, University of Pittsburgh
• ClinicalTrials.gov Identifier: NCT00177489
• Other Study ID Numbers: AG13305
• First Posted: Sep 15, 2005
• Last Update Posted: Jan 5, 2016
• Last Verified: Jan 1, 2016

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Keywords provided by Richard Schulz, Professor of Psychiatry, University of Pittsburgh: Family Caregivers; Dementia; Alzheimer Disease; Randomized Controlled Trial; Intervention Studies
• Additional relevant MeSH terms: Alzheimer Disease; Dementia

Study Results

No Results Posted as of Jan 5, 2016