Project TAP: Tailored Activities Project | NCT00259467

Studies
Project TAP: Tailored Activities Project

NCT00259467

Sponsor

Thomas Jefferson University

Status

Completed

Last Update Posted

Aug 25, 2010Estimated

Enrollment

Phase

Phase 1

Conditions

Alzheimer's Disease

Interventions

Home-Based Behavorial Intervention

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2004

Primary Completion Date

Not provided

Completion Date

Jan 2007

First Submitted Date

Nov 28, 2005

First Submission Date that Met QC Criteria

Nov 28, 2005

First Posted Date

Nov 29, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 24, 2010

Last Update Posted Date

Aug 25, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
Home-Based Behavorial Intervention	Behavioral

Measure	Description	Time Frame
Activity engagement and vigilance

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Laura N Gitlin, Ph.D	Thomas Jefferson University	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Thomas Jefferson University		Philadelphia	Pennsylvania	19107	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19420314	Derived	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.

ID	Term
D000544	Alzheimer Disease
D009043	Motor Activity
D003704	Dementia

ID	Term
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D024801	Tauopathies

Measure	Description	Time Frame
Behavioral occurrence
Care recipient depressive mood
Caregiver upset