Clinical trial NCT00259467: Project TAP: Tailored Activities Project
Official title: Tailored Activity to Improve Affect in Dementia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Alzheimer's Disease
Keywords: Activity, Dementia, Caregiving
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
First posted: 2005-11-29
Enrollment: 60
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

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.


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.

Primary outcomes:
measure: Behavioral occurrence
measure: Care recipient depressive mood
measure: Caregiver upset
Secondary outcomes:
measure: Activity engagement and vigilance
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
Study officials:
affiliation: Thomas Jefferson University
name: Laura N Gitlin, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.