NCT00177489

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
613

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2002

Longer than P75 for not_applicable

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2002

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2005

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
Last Updated

January 5, 2016

Status Verified

January 1, 2016

Enrollment Period

3.3 years

First QC Date

September 12, 2005

Last Update Submit

January 4, 2016

Conditions

DementiaAlzheimer Disease

Keywords

Family CaregiversDementiaAlzheimer DiseaseRandomized Controlled TrialIntervention Studies

Outcome Measures

Primary Outcomes (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 Outcomes (1)

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

    six months

Study Arms (2)

Treatment

EXPERIMENTAL

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

Control

OTHER

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

Other: Control arm

Interventions

multicomponent psychosocial interventionBEHAVIORAL

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.

Treatment
Control armOTHER

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

Control

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • 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
  • 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.
  • +11 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

University of Alabama at Birmingham

Birmingham, Alabama, 35294-2041, United States

Location

Stanford University and Veterans Affairs

Menlo Park, California, 94025, United States

Location

University of Miami at Miami, Center on Adult Development and Aging

Miami, Florida, 33136, United States

Location

Thomas Jefferson University at Philadelphia, Center for Applied Research on Aging and Health

Philadelphia, Pennsylvania, 19107, United States

Location

University of Tennessee Health Science Center

Memphis, Tennessee, 38163, United States

Location

Related Publications (3)

  • 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.

    PMID: 17116917RESULT

  • 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.

    PMID: 21391405DERIVED

  • 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.

    PMID: 20122038DERIVED

Related Links

MeSH Terms

Conditions

DementiaAlzheimer Disease

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental DisordersTauopathiesNeurodegenerative Diseases

Study Officials

  • Richard Schulz, Ph.D.

    Professor of Psychiatry and Director, University Center for Social and Urban Research, University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Psychiatry

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 15, 2005

Study Start

June 1, 2002

Primary Completion

September 1, 2005

Study Completion

September 1, 2005

Last Updated

January 5, 2016

Record last verified: 2016-01

Data Sharing

IPD Sharing
Will share

There is no plan to make individual participant data available.

Locations

US(5)