Project TAP: Tailored Activities Project

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-02-29

Study Completion Date

2007-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Alzheimer's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Blinding Strategy

DOUBLE

Interventions

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Home-Based Behavorial Intervention

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No