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OpenTrials
Completed

NCT Number: NCT00259467

Project TAP: Tailored Activities Project

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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Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Home-Based Behavorial Intervention

Behavioral

Primary outcomes

  1. Behavioral occurrence

  2. Care recipient depressive mood

  3. Caregiver upset

Secondary outcomes

  1. Activity engagement and vigilance

Sponsors and collaborators

Lead sponsor

Thomas Jefferson University

Other

Registry information

Official study title

Tailored Activity to Improve Affect in Dementia

Important dates

Study start
2004
Study completion
2007
First posted
Nov 29, 2005
Registry last updated
Aug 25, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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