Coordinating Center for Caregiver Intervention Trial

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.

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:

a. 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