Tailored Activity Program-VA
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|ClinicalTrials.gov Identifier: NCT01357564|
Recruitment Status : Active, not recruiting
First Posted : May 20, 2011
Last Update Posted : January 6, 2017
|Condition or disease||Intervention/treatment||Phase|
|Dementia||Other: Tailored Activity Program||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||160 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|Official Title:||Nonpharmacologic Management of Challenging Behaviors in Veterans With Dementia|
|Study Start Date :||August 2012|
|Primary Completion Date :||June 2016|
|Estimated Study Completion Date :||August 2018|
Comparison of attention control versus customized intervention activity.
Other: Tailored Activity Program
Intervention Protocol: In session #1, the interventionist, an occupational therapist (OT), meets with the caregiver and introduces the intervention goals. The OT provides and reviews a 3-ring binder which contains written educational materials about dementia, importance of taking care of self, communication strategies and other educational materials. Also provided and reviewed will be a copy of Mace and Rabins' book, The 36 Hour Day. The OT will interview the caregiver to obtain information about previous roles, habits, past and current daily routines, caregiver and Veteran preferences and interests. The OT will also observe interactions, noting communication and management style. The OT will also meet with the Veteran, observe social capacity using the Peavy Comportment scale and administer the Dementia Rating Scale (DRS-2).
- The primary outcome for the proposed trial is symptom reduction of neuropsychiatric behaviors (NPI total frequency by severity score) [ Time Frame: Year 1 through second quarter of Year 4 ]Data analysis is currently underway ( the primary outcome for the proposed trial is symptom reduction of neuropsychiatric behaviors (NPI total frequency by severity score)) and should be available mid 2017.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01357564
|United States, Florida|
|North Florida/South Georgia Veterans Health System, Gainesville, FL|
|Gainesville, Florida, United States, 32608|
|Principal Investigator:||William C. Mann, PhD MS BS||North Florida/South Georgia Veterans Health System, Gainesville, FL|