Back to results

Tailored Activity Program-Veterans Affairs

Primary Purpose

Dementia

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Tailored Activity Program

Attention Control

About this trial

This is an interventional supportive care trial for Dementia focused on measuring dementia, caregivers, tailored activity, neuropsychiatric symptoms, behavioral symptoms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Inclusion Criteria for Veterans with dementia include:

English speaking
diagnosed with dementia as above
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.
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).
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

Sites / Locations

North Florida/South Georgia Veterans Health System, Gainesville, FL

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Tailored Activity Program

Attention Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

The Neuropsychiatric Inventory (NPI). Measures the Frequency and Severity of Behavioral Symptoms in Dementia.

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

Secondary Outcome Measures

12-item Zarit Burden Short Form Measuring Caregiver Burden

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

Full Information

NCT ID

NCT01357564

First Posted

May 18, 2011

Last Updated

December 13, 2018

Sponsor

VA Office of Research and Development

1. Study Identification

Unique Protocol Identification Number

NCT01357564

Brief Title

Tailored Activity Program-Veterans Affairs

Official Title

Nonpharmacologic Management of Challenging Behaviors in Veterans With Dementia

Study Type

Interventional

2. Study Status

Record Verification Date

December 2018

Overall Recruitment Status

Completed

Study Start Date

August 2012 (undefined)

Primary Completion Date

June 2016 (Actual)

Study Completion Date

December 5, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

VA Office of Research and Development

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The Tailored Activity Program - Veterans Administration is a Phase III efficacy trial designed to reduce behavioral symptoms in Veterans with dementia living with their caregivers in the community. The study uses a randomized two group parallel design with 160 diverse Veterans and caregivers. The experimental group receives a transformative patient-centric intervention designed to reduce the burden of behavioral symptoms in Veterans with dementia. An occupational therapist conducts an assessment to identify a Veteran's preserved capabilities, deficit areas, previous roles, habits, and interests to develop activities tailored to the Veteran. Family caregivers are then trained to incorporate activities into daily care. The attention-control group receives bi-monthly telephone contact where education on topics relevant to dementia is provided to caregivers. Key outcomes include reduced frequency and severity of behavioral symptoms using the 12-item Neuropsychiatric Inventory (primary endpoint), reduced caregiver burden, enhanced skill acquisition, efficacy using activities, and time spent providing care at 4 months; and long-term effects (8 months) on the Veteran's quality of life and frequency and severity of behavioral symptoms, and caregiver use of activities. The programs' impact of Veterans Administration cost is also examined. Study precision will be increased through face-to-face research team trainings with procedural manuals and review of audio-taped interviews and intervention sessions.

Detailed Description

This study tests the efficacy of a transformative patient-centric intervention designed to reduce the burden of NPS in Veterans with dementia who live at home with family caregivers. The innovative intervention, the Tailored Activity Program (TAP-VA), involves 8 sessions over 4 months in Veterans' homes. An occupational therapist conducts a systematic assessment to identify a Veteran's preserved capabilities and deficit areas, and previous roles, habits and interests from which to develop and introduce activities tailored to the Veteran's profile. Family caregivers are then trained to incorporate tailored activities into daily care routines. The intervention was pilot tested in an NIMH funded study with 60 community-living individuals with dementia. Findings from this pilot showed statistically significant and clinically meaningful reductions in NPS, specifically agitation and less time being on "duty" by family caregivers. Results of this pilot phase support moving forward with a full-scale Phase III efficacy trial. The investigators tested TAP-VA in a randomized two-group parallel design in which 160 racially and ethnically diverse Veterans with dementia and their family caregivers (dyads) were randomly assigned to receive TAP-VA or an attention control group. All dyads were evaluated at baseline and 4-months (main trial endpoint), and then reassessed at 8-months to evaluate long-term treatment effects (baseline to 8 months), including continued activity use, caregiver well-being, and costs.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dementia

Keywords

dementia, caregivers, tailored activity, neuropsychiatric symptoms, behavioral symptoms

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

322 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Tailored Activity Program

Arm Type

Experimental

Arm Description

Arm Title

Attention Control

Arm Type

Active Comparator

Arm Description

Intervention Type

Other

Intervention Name(s)

Tailored Activity Program

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Attention Control

Intervention Description

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.

Primary Outcome Measure Information:

Title

The Neuropsychiatric Inventory (NPI). Measures the Frequency and Severity of Behavioral Symptoms in Dementia.

Description

Time Frame

Baseline, 4 month (short-term follow-up), 8 month (long-term)

Secondary Outcome Measure Information:

Title

12-item Zarit Burden Short Form Measuring Caregiver Burden

Description

Time Frame

Baseline, 4 month (short-term follow-up), 8 month (long-term)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Inclusion Criteria for Veterans with dementia include: English speaking diagnosed with dementia as above 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. 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). 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ivette Freytes, PhD MS BS

Organizational Affiliation

North Florida/South Georgia Veterans Health System, Gainesville, FL

Official's Role

Principal Investigator

Facility Information:

Facility Name

North Florida/South Georgia Veterans Health System, Gainesville, FL

City

Gainesville

State/Province

Florida

ZIP/Postal Code

32608

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

24060106

Citation

Gitlin LN, Mann WC, Vogel WB, Arthur PB. A non-pharmacologic approach to address challenging behaviors of Veterans with dementia: description of the tailored activity program-VA randomized trial. BMC Geriatr. 2013 Sep 23;13:96. doi: 10.1186/1471-2318-13-96.

Results Reference

background

PubMed Identifier

29192967

Citation

Gitlin LN, Arthur P, Piersol C, Hessels V, Wu SS, Dai Y, Mann WC. Targeting Behavioral Symptoms and Functional Decline in Dementia: A Randomized Clinical Trial. J Am Geriatr Soc. 2018 Feb;66(2):339-345. doi: 10.1111/jgs.15194. Epub 2017 Nov 28.

Results Reference

result

Links:

URL

http://www.alz.org

Description

Alzheimer's information site

Learn more about this trial

Tailored Activity Program-Veterans Affairs

We'll reach out to this number within 24 hrs