DementiaNCT01357564
Tailored Activity Program-Veterans Affairs
A study testing Tailored Activity Program in people with Dementia, run by VA Office of Research and Development at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dementia
- What is being tested?
- Tailored Activity Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 322 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to 5 Dec 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- English speaking
- diagnosed with dementia as above
- able to participate in at least two activities of daily living
- ADLs - bathing
- dressing
- grooming
Show all 26Show fewer
- 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.
Who cannot join
- Non English speaking
- Non-Veteran
- No caregiver
- No diagnosis of dementia
Trial locations and contacts
1 site in 1 country.
United States1 site
North Florida/South Georgia Veterans Health System, Gainesville, FL
Gainesville, Florida, 32608
About this study
Official title: Nonpharmacologic Management of Challenging Behaviors in Veterans With Dementia
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.
Read the 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.
- Conditions
- Dementia
- Being tested
- Tailored Activity Program, Attention Control
- Keywords
- dementia, caregivers, tailored activity, neuropsychiatric symptoms, behavioral symptoms
- Medical subject headings
- Dementia, Behavioral Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tailored Activity ProgramOther
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.
Attention ControlOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Tailored Activity Program | Experimental | 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. Receives: Other: Tailored Activity Program |
| Attention Control | Active comparator | 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. Receives: Other: Attention Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline, 4 month (short-term follow-up), 8 month (long-term)
Secondary outcomes (1)
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
Measured: Baseline, 4 month (short-term follow-up), 8 month (long-term)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2011 (estimated)
- Study startAug 2012
- Primary completionJun 2016
- Study completion5 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 322 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Ivette Freytes, PhD MS BS, Principal investigator, North Florida/South Georgia Veterans Health System, Gainesville, FL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01357564
- Sponsor's protocol ID
- IIR 11-119
- Status last verified
- Dec 2018
- First submitted
- 18 May 2011
- Last updated
- 22 Mar 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 24060106Gitlin 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.
PubMed 29192967
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nonpharmacologic Management of Challenging Behaviors in Veterans With Dementia
- ClinicalTrials.gov ID
- NCT01357564
- Acronym / sponsor ID
- IIR 11-119
- Conditions
- Dementia
- Keywords
- dementia, caregivers, tailored activity, neuropsychiatric symptoms, behavioral symptoms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 322 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- Aug 2012
- Primary completion
- Jun 2016 (actual)
- Study completion
- 5 Dec 2018 (actual)
- First posted
- 20 May 2011 (estimated)
- Results
- Posted 22 Mar 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tailored Activity Program | Experimental | Other: Tailored Activity ProgramOccupational 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. |
| Attention Control | Active comparator | Other: Attention ControlCaregivers 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (26 listed)
- English speaking
- diagnosed with dementia as above
- able to participate in at least two activities of daily living
- not currently participating in any other dementia-related intervention.
- If the Veteran with dementia is on any of four classes of psychotropic medications:
Key exclusion criteria (4 listed)
- Non English speaking
- Non-Veteran
- No caregiver
- No diagnosis of dementia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tailored Activity ProgramThe 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. | Other | Tailored Activity Program |
| Attention ControlCaregivers 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. | Other | Attention Control |
Primary outcome
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
1 secondary outcome
12-item Zarit Burden Short Form Measuring Caregiver Burden
Time frame: Baseline, 4 month (short-term follow-up), 8 month (long-term)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 24060106Gitlin 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 publication: PubMed 29192967Gitlin 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.
- Alzheimer's information siteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ivette Freytes, PhD MS BS principal investigator
North Florida/South Georgia Veterans Health System, Gainesville, FL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tailored Activity Program in people with Dementia, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 26 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Mar 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01357564, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2019.