Skip to content

Project TAP: Tailored Activities Project

Tailored Activity to Improve Affect in Dementia

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00259467
Enrollment
60
Registered
2005-11-29
Start date
2004-02-29
Completion date
2007-01-31
Last updated
2010-08-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer's Disease

Keywords

Activity, Dementia, Caregiving

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.

Interventions

BEHAVIORALHome-Based Behavorial Intervention

Sponsors

Thomas Jefferson University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Behavioral occurrence
Care recipient depressive mood
Caregiver upset

Secondary

MeasureTime frame
Activity engagement and vigilance

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026