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Project TAP: Tailored Activities Project

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00259467
First Posted: November 29, 2005
Last Update Posted: August 25, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Thomas Jefferson University
  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
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

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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: R21MH069425 ( U.S. NIH Grant/Contract )
First Submitted: November 28, 2005
First Posted: November 29, 2005
Last Update Posted: August 25, 2010
Last Verified: August 2010

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
Neurocognitive Disorders
Mental Disorders