Project TAP: Tailored Activities Project

This study has been completed.
Sponsor:
Information provided by:
Thomas Jefferson University
ClinicalTrials.gov Identifier:
NCT00259467
First received: November 28, 2005
Last updated: August 24, 2010
Last verified: August 2010
  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 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double-Blind
Official Title: Tailored Activity to Improve Affect in Dementia

Resource links provided by NLM:


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 by Thomas Jefferson University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Laura N. Gitlin, Ph.D, Jefferson Center for Applied Research on Aging and Health
ClinicalTrials.gov Identifier: NCT00259467     History of Changes
Other Study ID Numbers: R21 MH069425
Study First Received: November 28, 2005
Last Updated: August 24, 2010
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on April 16, 2014