Project TAP: Tailored Activities Project

Alzheimer's Disease Clinical Trial

Official title:

Tailored Activity to Improve Affect in Dementia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00259467
• Other study ID #: R21MH069425
• Status: Completed
• Phase: Phase 1
• First received: November 28, 2005
• Last updated: August 24, 2010
• Start date: February 2004
• Est. completion date: January 2007

Study information

• Verified date: August 2010
• Source: Thomas Jefferson University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Double-Blind

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Behavioral:
• Home-Based Behavorial Intervention

Locations

Country	Name	City	State
United States	Thomas Jefferson University	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Thomas Jefferson University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Behavioral occurrence
Primary	Care recipient depressive mood
Primary	Caregiver upset
Secondary	Activity engagement and vigilance