Tailored Activity Program-Veterans Affairs
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01357564 |
Recruitment Status :
Completed
First Posted : May 20, 2011
Results First Posted : March 22, 2019
Last Update Posted : March 22, 2019
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Condition or disease | Intervention/treatment | Phase |
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Dementia | Other: Tailored Activity Program Other: Attention Control | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 322 participants |
Allocation: | Randomized |
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 |
Actual Primary Completion Date : | June 2016 |
Actual Study Completion Date : | December 5, 2018 |

Arm | Intervention/treatment |
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Experimental: Tailored Activity Program
Occupational therapists assess the person's home environment, preserved capabilities, daily routines, interests and the caregiver's readiness and ability to use activities. Activities are developed that reflect the Veteran's previous or current interests and are modified to match their preserved capabilities without taxing the most impaired areas of cognition (e.g., memory, new learning). TAP-VA provides caregivers with the knowledge and skills to use activities. The overall goal is to provide predictability, familiarity, and structure in the daily life of the Veteran and establish a level of environmental stimulation appropriate to that person's abilities.
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Other: Tailored Activity Program
The interventionist, an occupational therapist, meets with the caregiver and introduces the intervention goals. The OT provides and reviews written educational materials about dementia, importance of taking care of self, communication strategies and other educational materials. Also provided and reviewed is The 36 Hour Day. The OT interviews the caregiver to obtain information about previous roles, habits, past and current daily routines, caregiver and Veteran preferences and interests. The OT also observes 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. |
Active Comparator: Attention Control
Caregivers in this group receive bi-weekly telephone contact by a trained healthcare professional. In each session, caregivers are provided important information about dementia and strategies for disease management. Each telephone contact begins with a brief overview of the specific purpose of the session, followed by a description of the key facts about the session topic, and concludes with a question and answer period. The attention control group intervention is delivered by a member of the research team who is knowledgeable about dementia and has had prior experience working with family caregivers.
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Other: Attention Control
Caregivers in this group received bi-weekly telephone contact by a trained healthcare professional. In each session, caregivers were provided information about dementia and strategies for disease management. Each telephone contact began with a brief overview the session purpose, followed by a description of key facts, and concluded with a question and answer period. The attention control group intervention was delivered by a member of the research team who is knowledgeable about dementia and has had prior experience working with family caregivers. |
- The Neuropsychiatric Inventory (NPI). Measures the Frequency and Severity of Behavioral Symptoms in Dementia. [ Time Frame: Baseline, 4 month (short-term follow-up), 8 month (long-term) ]
The Neuropsychiatric Inventory (NPI) assesses the frequency and severity of 12 common behavioral symptoms in dementia.
The NPI Score is calculated by multiplying the total reported frequency by the severity score, with a theoretical range of 0-1704: high scores indicating greater frequency by severity.
The change between 2 or more time points is being reported. Baseline to T2 (4 months) - short-term measure; and baseline to T3 (8 months) - long term measure
- 12-item Zarit Burden Short Form Measuring Caregiver Burden [ Time Frame: Baseline, 4 month (short-term follow-up), 8 month (long-term) ]
Caregiver burden as measured by the 12-item Zarit Burden Short Form.
Scores range from 0-48, with higher scores indicating burden; scores over 17 indicate particularly high levels of caregiver burden.
The change between 2 or more time points is being reported. Baseline to T2 (4 months) - short-term measure; and baseline to T3 (8 months) - long term measure

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Inclusion Criteria for Veterans with dementia include:
- English speaking
- diagnosed with dementia as above
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able to participate in at least two activities of daily living
- ADLs - bathing
- dressing
- grooming
- toileting
- transferring from bed to chair
- not currently participating in any other dementia-related intervention.
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If the Veteran with dementia is on any of four classes of psychotropic medications:
- antidepressant
- benzodiazepines
- antipsychotic
- anti-convulsant
- an anti-dementia medication (memantine or a cholinesterase inhibitor)
- We will require that he/she have been on a stable dose for 60 days prior to enrollment to minimize possible confounding effects of concomitant medications (the typical time frame used in clinical trials).
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Caregivers of Veterans must be:
- English speaking
- self-identify as the primary member of the family caring (hands-on or supervision) for the Veteran and 21 years of age or older (male or female)
- living with the Veteran
- accessible by telephone to schedule interview, intervention sessions and follow-up interviews
- planning to live in area for 8 months (to reduce loss to follow-up)
- indicate willingness to learn activity use
- report one or more NPS in the Veteran in the past month
- not currently participating in any other caregiver-related intervention.
- Finally, we will require that caregivers taking a psychotropic medication (antidepressant, benzodiazepines, antipsychotic, or anti-convulsant) at time of telephone screen be on a stable dose of the medication for 60 days prior to enrollment.
Exclusion Criteria:
- Non English speaking
- Non-Veteran
- No caregiver
- No diagnosis of dementia

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: | Ivette Freytes, PhD MS BS | North Florida/South Georgia Veterans Health System, Gainesville, FL |
Publications of Results:
Other Publications:
Responsible Party: | VA Office of Research and Development |
ClinicalTrials.gov Identifier: | NCT01357564 |
Other Study ID Numbers: |
IIR 11-119 |
First Posted: | May 20, 2011 Key Record Dates |
Results First Posted: | March 22, 2019 |
Last Update Posted: | March 22, 2019 |
Last Verified: | December 2018 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
dementia caregivers tailored activity neuropsychiatric symptoms behavioral symptoms |
Dementia Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Neurocognitive Disorders Mental Disorders |