- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00259467
Project TAP: Tailored Activities Project
August 24, 2010 updated by: Thomas Jefferson University
Tailored Activity to Improve Affect in Dementia
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment
60
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19107
- Thomas Jefferson University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Behavioral occurrence
|
Care recipient depressive mood
|
Caregiver upset
|
Secondary Outcome Measures
Outcome Measure |
---|
Activity engagement and vigilance
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Laura N Gitlin, Ph.D, Thomas Jefferson University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2004
Study Completion
January 1, 2007
Study Registration Dates
First Submitted
November 28, 2005
First Submitted That Met QC Criteria
November 28, 2005
First Posted (Estimate)
November 29, 2005
Study Record Updates
Last Update Posted (Estimate)
August 25, 2010
Last Update Submitted That Met QC Criteria
August 24, 2010
Last Verified
August 1, 2010
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- R21MH069425 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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