Coordinating Center for Caregiver Intervention Trial

Alzheimer Disease Clinical Trial

— REACH  

Official title:

Coordinating Center for Multisite Intervention Trial for Diverse Caregivers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00177489
• Other study ID #: AG13305
• Status: Completed
• Phase: N/A
• First received: September 12, 2005
• Last updated: January 4, 2016
• Start date: June 2002
• Est. completion date: September 2005

Study information

• Verified date: January 2016
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 613
• Est. completion date: September 2005
• Est. primary completion date: September 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alzheimer Disease
• Dementia

Intervention

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

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	University of Tennessee Health Science Center	Memphis	Tennessee
United States	Stanford University and Veterans Affairs	Menlo Park	California
United States	University of Miami at Miami, Center on Adult Development and Aging	Miami	Florida
United States	Thomas Jefferson University at Philadelphia, Center for Applied Research on Aging and Health	Philadelphia	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
University of Pittsburgh	National Institute of Nursing Research (NINR), National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 I — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Caregiver clinical depression and patient institutional placement-six months post-randomization.		six months	No

External Links

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