Dementia
Conditions
Keywords
dementia, caregivers, tailored activity, neuropsychiatric symptoms, behavioral symptoms
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.
Interventions
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.
OTHERAttention 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.
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Neuropsychiatric Inventory (NPI). Measures the Frequency and Severity of Behavioral Symptoms in Dementia. | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 12-item Zarit Burden Short Form Measuring Caregiver Burden | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Tailored Activity Program Tailored intervention activity.
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. | 154 |
| Attention Control Attention control.
Caregivers in this group receive bi-weekly telephone contact (up to 8 contacts) by a trained healthcare professional. In each session, caregivers are provided important information about dementia and strategies for managing the disease at home (Table 2). Each telephone contact is approximately 30 minutes in length and 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. Table 2 outlines the specific domain and session content that is covered. 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. | 168 |
| Total | 322 |
Baseline characteristics
| Characteristic | Tailored Activity Program | Attention Control | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 130 Participants | 140 Participants | 270 Participants |
| Age, Categorical Between 18 and 65 years | 24 Participants | 28 Participants | 52 Participants |
| Age, Continuous | 77.43 years | 71.34 years | 76.21 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 2 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 150 Participants | 165 Participants | 315 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 20 Participants | 33 Participants | 53 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 5 Participants | 8 Participants | 13 Participants |
| Race (NIH/OMB) White | 129 Participants | 127 Participants | 256 Participants |
| Region of Enrollment United States | 154 Participants | 168 Participants | 322 Participants |
| Sex: Female, Male Female | 77 Participants | 84 Participants | 161 Participants |
| Sex: Female, Male Male | 77 Participants | 84 Participants | 161 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 5 / 154 | 9 / 168 |
| other Total, other adverse events | 0 / 154 | 0 / 168 |
| serious Total, serious adverse events | 7 / 154 | 4 / 168 |
Outcome results
Primary
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
Time frame: Baseline, 4 month (short-term follow-up), 8 month (long-term)
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Tailored Activity Program | The Neuropsychiatric Inventory (NPI). Measures the Frequency and Severity of Behavioral Symptoms in Dementia. | T1-T2 (sort term) Change | -38.1 score on a scale |
| Tailored Activity Program | The Neuropsychiatric Inventory (NPI). Measures the Frequency and Severity of Behavioral Symptoms in Dementia. | T1-T3 (long term) Change | -12 score on a scale |
| Attention Control | The Neuropsychiatric Inventory (NPI). Measures the Frequency and Severity of Behavioral Symptoms in Dementia. | T1-T2 (sort term) Change | 1.0 score on a scale |
| Attention Control | The Neuropsychiatric Inventory (NPI). Measures the Frequency and Severity of Behavioral Symptoms in Dementia. | T1-T3 (long term) Change | -9.8 score on a scale |
Comparison: Sample size calculation was based on the main study hypothesis tested at 80% power for a 2-sided alternative hypothesis using a t-test comparing the treatment groups on 4-month values. Based on previous trials, we sought a medium effect size of 0.50 using a type I error rate of .05.p-value: 0.0295% CI: [-1.23, -0.13]t-test, 2 sided
Secondary
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
Time frame: Baseline, 4 month (short-term follow-up), 8 month (long-term)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tailored Activity Program | 12-item Zarit Burden Short Form Measuring Caregiver Burden | T1-T2 (short term) change | -1.4 units on a scale |
| Tailored Activity Program | 12-item Zarit Burden Short Form Measuring Caregiver Burden | T1-T3 (long term) change | -0.7 units on a scale |
| Attention Control | 12-item Zarit Burden Short Form Measuring Caregiver Burden | T1-T2 (short term) change | -1.6 units on a scale |
| Attention Control | 12-item Zarit Burden Short Form Measuring Caregiver Burden | T1-T3 (long term) change | 0.01 units on a scale |
Comparison: Sample size calculation was based on the main study hypothesis tested at 80% power for a 2-sided alternative hypothesis using a t-test comparing the treatment groups on 4-month values. Based on previous trials, we sought a medium effect size of 0.50 using a type I error rate of .05.p-value: 0.0395% CI: [-0.14, -0.01]t-test, 2 sided