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Targeting Behavioral Symptoms and Functional Decline in Dementia: A Randomized Clinical Trial

Contact Information


Laura N. Gitlin,

caregiving; functional decline; home care; neuropsychiatric symptoms; quality of life.


Background/objectives: Dementia-related behavioral symptoms and functional dependence result in poor quality of life for persons with dementia and their caregivers. The goal was to determine whether a home-based activity program (Tailored Activity Program; TAP-VA) would reduce behavioral symptoms and functional dependence of veterans with dementia and caregiver burden. Design: Single-blind (interviewer), parallel, randomized, controlled trial ( NCT01357564). Setting: Veteran's homes. Participants: Veterans with dementia and their family caregivers (N = 160 dyads). Intervention: Dyads in TAP-VA underwent 8 sessions with occupational therapists to customize activities to the interests and abilities of the veterans and educate their caregivers about dementia and use of customized activity. Caregivers assigned to attention control received up to 8 telephone-based dementia education sessions with a research team member. Measurements: Primary outcomes included number of behaviors and frequency of their occurrence multiplied by severity of occurrence; secondary outcomes were functional dependence, pain, emotional well-being, caregiver burden (time spent caregiving, upset with behaviors) and affect at 4 (primary endpoint) and 8 months. Results: Of 160 dyads (n = 76 TAP-VA; n = 84 control), 111 completed 4-month interviews (n = 51 TAP-VA; n = 60 control), and 103 completed 8-month interviews (n = 50 TAP-VA; n = 53 control). At 4 months, compared to controls, the TAP-VA group showed reductions in number (difference in mean change from baseline = -0.68, 95% CI = -1.23 to -0.13) and frequency by severity (-24.3, 95% CI = -45.6 to -3.1) of behavioral symptoms, number of activities needing assistance with (-0.80, 95% CI = -1.41 to -0.20), functional dependence level (4.09, 95% CI = 1.06, 7.13), and pain (-1.18, 95% CI = -2.10 to -0.26). Caregivers of veterans in TAP-VA reported less behavior-related distress. Benefits did not extend to 8 months. Conclusion: TAP-VA had positive immediate effects and no adverse events. Because TAP-VA reduces behavioral symptoms, slows functional dependence, and alleviates pain and caregiver distress, it is a viable treatment option for families.


Gitlin, L. N., Arthur, P., Piersol, C., Hessels, V., Wu, S. S., Dai, Y., & Mann, W. C. (2018). Targeting Behavioral Symptoms and Functional Decline in Dementia: A Randomized Clinical Trial. Journal of the American Geriatrics Society, 66(2), 339–345.





Conent Area

Laura N. Gitlin,

EWB-Related Construct

(4) quality of life

Study Design

Species or Study Population

(5) RCT

Sex (%Female)

patients/veterans: 3.1%
caregivers: 97.6%

Age (Mean, SD)

patients/veterans: 80.4, 8.7
caregivers: 72.4, 10.6

Younger Controls?


Longitudinal Data?


Sample Size



8 sessions home-based activity program (Tailored Activity Program; TAP-VA)

Ethnicity (%white)

patients/veterans: 93.1%
caregivers: 81.1%

Inclusion Criteria

For veterans:
(1) English speaking
(2) had a Mini-Mental State Examination (MMSE) score of 23 or less, or a physician diagnosis of dementia
(3) were able to participate in 2 or more self-care activities
(4) were not involved in another study
(5) Veterans taking medications from any of 4 classes of psychotropic medications or an antidementia medication who were on a stable dose 60 days before enrollment were eligible.
For caregivers:
(1) English-speaking
(2) primary caregivers aged 21 and older and living with the veteran
(3) accessible by telephone, planned to live in area for 8 months, were willing to learn activities, had managed 1 or more behavioral symptoms in past month
(4) were not participating in another study
(5) Caregivers taking psychotropic medications who were on a stable dose 60 days before enrollment were eligible.

Exclusion Criteria


EWB Measures

(1) quality-of-life (Albert SM)

Non-EWB Behavioral

(1) Neuropsychiatric Inventory—Clinician (NPI-C)
(2) Caregiver Assessment of Function and Upset Scale (CAFU): instrumental activities of daily living (IADLs), activities of daily living (ADLs)
(3) Pain Intensity Scale items
(4) Time spent caregiving
(5) Centers for Epidemiologic Study Depression Scale (CES-D)

Physiological Measures


Brain IMaging Modality

Brain IMaging Paradigm


Brain Region/Circuit


Biological Measures


Other Neural Measures

Data Availability?


Data Avalability Details


Diagnostic Measures

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