Project TAP: Tailored Activities Project - Full Text View

Purpose

Specific Aims

Establish a preliminary effect size for the impact of the intervention on depressive affect and agitated behaviors in persons with dementia in 4 months
Evaluate acceptance of and engagement in activities in persons with dementia
Establish a preliminary effect size for the impact of the intervention on caregiver burden, depressive symptoms, and mastery at 4 months.
Evaluate caregiver skills acquisition, acceptance of and compliance to intervention techniques.

Condition	Intervention	Phase
Alzheimer's Disease	Behavioral: Home-Based Behavorial Intervention	Phase I

Genetics Home Reference related topics:

Alzheimer disease

MedlinePlus related topics:

Alzheimer's Disease Caregivers Dementia

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Educational/Counseling/Training, Randomized, Double-Blind, Active Control, Single Group Assignment

Official Title:	Tailored Activity to Improve Affect in Dementia

Further study details as provided by Thomas Jefferson University:

Primary Outcome Measures:

Secondary Outcome Measures:

Estimated Enrollment:	60
Study Start Date:	February 2004
Estimated Study Completion Date:	January 2007

Eligibility

Criteria

Inclusion Criteria:

Care Recipient
English Speaking
NINCDS-ADRDA diagnosis[physician generated of dementia or mini-mental state examination score of less than or equal to 23;3] Able to feel self; and participates in at least 2 other activities of daily living[ADLs-Bathing, Dressing, Grooming, Toileting, Transferring from bed to chair] As reported by caregiver.
Caregiver
English Speaking
Family member 21 years of age or older [male or female]
Lives with Care Recipient
Has telephone in the home
Plans to live in area for 8 months
Indicated willingness to learn new approaches by which to engage care recipient in meaningful activities
Provides 4 or more hours a day directly caring or providing for care recipient

Exclusion Criteria:

Care Recipient
Has Schizophrenia or Bi-Polar Disorder
Their Dementia is secondary to probable head trauma
Their MMSE score is equal to zero and they are bed bound, defined as confinement to bed or chair for at least 22 hours a day for at least 4 of 7 days
They are not responsive to their environment
Caregiver
Are currently involved in another clinical trial of psycho-social or educational interventions for caregivers
Are planning to place their family member in a nursing home within the next 8 months. Also, the care recipient/caregiver dyad will be excluded if either caregiver or care recipient: 1) has a terminal illness with life expectancy less than 8 months 2)is in active treatment for cancer or 3) has had greater than 3 acute medical hospitalizations within the past year.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00259467

Locations


United States, Pennsylvania
	Thomas Jefferson University
	Philadelphia, Pennsylvania, United States, 19107

Sponsors and Collaborators

Thomas Jefferson University

Investigators


Principal Investigator:	Laura N Gitlin, Ph.D	Thomas Jefferson University

More Information

Study ID Numbers:	R21 MH069425
First Received:	November 28, 2005
Last Updated:	April 17, 2007
ClinicalTrials.gov Identifier:	NCT00259467
Health Authority:	United States: Institutional Review Board