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Project TAP: Tailored Activities Project

Phase 1
Completed
Conditions
Alzheimer's Disease
Registration Number
NCT00259467
Lead Sponsor
Thomas Jefferson University
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
60
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Primary Outcome Measures
NameTimeMethod
Caregiver upset
Care recipient depressive mood
Behavioral occurrence
Secondary Outcome Measures
NameTimeMethod
Activity engagement and vigilance

Trial Locations

Locations (1)

Thomas Jefferson University

🇺🇸

Philadelphia, Pennsylvania, United States

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