Project TAP: Tailored Activities Project

NCT00259467 | Completed Phase 1

• 1 other identifier: R21MH069425
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Specific Aims

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

Conditions

Alzheimer's Disease

Keywords

Activity, Dementia, Caregiving

Outcome Measures

Primary Outcomes (3)

• Behavioral occurrence

• Care recipient depressive mood

• Caregiver upset

Secondary Outcomes (1)

• Activity engagement and vigilance

Interventions

Home-Based Behavorial Intervention BEHAVIORAL

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Thomas Jefferson University: lead

Study Sites (1)

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Related Publications (1)

• Gitlin LN, Winter L, Vause Earland T, Adel Herge E, Chernett NL, Piersol CV, Burke JP. The Tailored Activity Program to reduce behavioral symptoms in individuals with dementia: feasibility, acceptability, and replication potential. Gerontologist. 2009 Jun;49(3):428-39. doi: 10.1093/geront/gnp087. Epub 2009 May 6.

  PMID: 19420314 DERIVED

MeSH Terms

Conditions

Alzheimer Disease; Motor Activity; Dementia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Behavior

Study Officials

• Laura N Gitlin, Ph.D

  Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 28, 2005
• First Posted: November 29, 2005
• Study Start: February 1, 2004
• Study Completion: January 1, 2007
• Last Updated: August 25, 2010

Record last verified: 2010-08

Locations

US (1)