Project TAP: Tailored Activities Project

Study Overview
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Brief Summary
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Specific Aims Establish a preliminary effect size for the impact of the intervention on depressive affect and agitated behaviors in persons with dementia in 4 months Evaluate acceptance of and engagement in activities in persons with dementia Establish a preliminary effect size for the impact of the intervention on caregiver burden, depressive symptoms, and mastery at 4 months. Evaluate caregiver skills acquisition, acceptance of and compliance to intervention techniques.

Official Title
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Tailored Activity to Improve Affect in Dementia

Conditions
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Alzheimer's Disease

Intervention / Treatment
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* Behavioral: Home-Based Behavorial Intervention


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Home-Based Behavorial Intervention|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Behavioral occurrence |  |  | 
| Care recipient depressive mood |  |  | 
| Caregiver upset |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Activity engagement and vigilance |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Activity, Dementia, Caregiving