NCT00259467

CompletedPhase 1

Project TAP: Tailored Activities Project

Thomas Jefferson University Source

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Other study identifiers

Sponsor study identifier

R21MH069425

NIH

Study Type

interventional

Reported enrollment (type unavailable)

60

Locations

1 country

Sites

1

Timeline

Study Start

February 2004

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

Not reported

Date not reported

Study Completion

January 2007

Date type not reported

This date has not been verified as actual or estimated.

Brief Summary

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Reported enrollment (type unavailable): 60 participants
Study completion date: January 2007
Date type not reported
This date has not been verified as actual or estimated.
Listed locations: 1 countries · 1 sites

Trial Relationships

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Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
February 2004
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
November 28, 2005
Actual (reported)
First Posted
November 29, 2005
Actual (reported)
Study Completion
January 2007
Date type not reported
This date has not been verified as actual or estimated.

Last Updated: August 25, 2010
Status Verified: August 2010
Last Update Submitted: August 24, 2010

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 InterventionBehavioral

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age21 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Care Recipient
English Speaking

Sponsors & Collaborators

Thomas Jefferson University
Otherlead

Study Sites (1)

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

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: 19420314DERIVED

MeSH Terms

Conditions

Alzheimer DiseaseMotor ActivityDementia

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental DisordersBehavior

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 2004

Date type not reported

This date has not been verified as actual or estimated.

Study Completion

January 2007

Date type not reported

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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.

Contact the study team to confirm eligibility.

This date has not been verified as actual or estimated.

Last Updated

August 25, 2010

Record last verified: 2010-08

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT00259467
Data provider: ClinicalTrials.gov
Source updated: 2010-08-25
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:29:02 UTC

Locations

US(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (1)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations