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Project TAP: Tailored Activities Project
This study is ongoing, but not recruiting participants.
First Received: November 28, 2005   Last Updated: April 17, 2007   History of Changes
Sponsored by: Thomas Jefferson University
Information provided by: Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT00259467
  Purpose

Specific Aims

  1. Establish a preliminary effect size for the impact of the intervention on depressive affect and agitated behaviors in persons with dementia in 4 months
  2. Evaluate acceptance of and engagement in activities in persons with dementia
  3. Establish a preliminary effect size for the impact of the intervention on caregiver burden, depressive symptoms, and mastery at 4 months.
  4. 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:
  • Behavioral occurrence
  • Care recipient depressive mood
  • Caregiver upset

Secondary Outcome Measures:
  • Activity engagement and vigilance

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

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

No publications provided

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

Keywords provided by Thomas Jefferson University:
Activity, Dementia, Caregiving

Study placed in the following topic categories:
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Alzheimer Disease
Central Nervous System Diseases
Neurodegenerative Diseases
Brain Diseases
Dementia
Cognition Disorders
Delirium

Additional relevant MeSH terms:
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Nervous System Diseases
Alzheimer Disease
Central Nervous System Diseases
Neurodegenerative Diseases
Tauopathies
Brain Diseases
Dementia

ClinicalTrials.gov processed this record on May 07, 2009