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IIR 11-119 – HSR&D Study

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IIR 11-119
Nonpharmacologic Management of Challenging Behaviors in Veterans with Dementia
William C. Mann PhD MS BS
North Florida/South Georgia Veterans Health System, Gainesville, FL
Gainesville, FL
Funding Period: December 2011 - July 2016

BACKGROUND/RATIONALE:
A hallmark of dementia is neuropsychiatric symptoms (NPS) which include agitation, apathy, depression, mood lability, and aggressiveness. This study addresses the challenge of managing NPS by testing 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. NPS are associated with increased health care costs, and reduced quality of life and daily functioning, heightened family caregiver burden, and nursing home placement. 4,5 Standard care typically involves pharmacologic agents, but these are at best modestly effective, carry serious risks including mortality, and do not address behavioral symptoms families themselves consider most distressful or that prompt nursing home placement. Given the devastating effects of the disease and that a cure is not imminent, medical organizations nationally and internationally including the VA have urged for the development and testing of new approaches to manage NPS.

OBJECTIVE(S):
Our primary study aim concerns the Veteran with dementia and tests the immediate effect of TAP-VA at 4-months on NPS. Our hypothesis is that Veterans with dementia who receive TAP-VA will manifest lower total scores on the Neuropsychiatric Inventory (NPI), which assesses frequency and severity of 12 common neuropsychiatric symptoms, compared to Veterans assigned to an attention control group.

We also propose four secondary aims. These are to: 1) Test the longer-term effects of TAP-VA at 8-months on quality of life and neuropsychiatric behaviors of Veterans with dementia. Hypothesis: Veterans receiving TAP-VA will manifest higher quality of life and lower total NPI scores over time (baseline to 8-months) in comparison to Veterans in the attention control group; 2) Test the immediate effects of TAP-VA at 4-months and long-term effects at 8-months on caregiver burden, skill acquisition, efficacy using activities, and time spent providing care. Hypotheses: Caregivers receiving TAP-VA will report reduced burden, enhanced skills and efficacy using activities, and less time providing care compared to the control group at 4 and 8-months; 3) Examine whether caregivers receiving TAP-VA are using activities at 8 months; and 4) Examine whether TAP-VA results in reduced VHA health care use and costs for Veterans with dementia and their caregivers. Results from these secondary aims will provide further evidence of treatment efficacy, identify whether booster sessions are necessary, and inform dissemination efforts and translation of TAP-VA system-wide.

Our long-term objective, if proven efficacious, is to integrate TAP-VA into standard care practices within the VHA system as the first treatment choice to address NPS in Veterans with dementia living at home. This would transform the current paradigm of dementia care which relies on pharmacologic management.

METHODS:
This study will test whether a targeted Veteran-centric intervention reduces NPS (NPI total score of frequency by severity) and, secondarily, whether it reduces burden by reducing time spent in care, and enhancing skill in family caregivers. We also seek to evaluate its cost savings in terms of health care utilization rates of both Veterans and family caregivers.

We will enroll 160 Veterans with dementia whose caregivers report one or more NPS and are living at home. Veterans with diagnosis codes 290.0, 290.2, 290.3, 331.2 (senile dementias), 290.4 (vascular dementia), 294.8 (dementia not otherwise specified), 331.0 (Alzheimer's disease), 331.1 (frontotemporal dementia), and 331.82 (Lewy body dementia) will be considered to have dementia diagnoses and eligible for study participation. Veterans with these diagnostic codes will be recruited from NF/SG VHS Geriatric Research, Education & Clinical Center (GRECC) and Geriatrics and Extended Care Service (GECS) outpatient services, including the Home Based Patient Care (HBPC) and Homemaker Home Health Aide program.

Eligible dyads will receive a baseline home interview (T1), and then be randomized to experimental (TAP-VA) or attention-control group conditions. Experimental dyads will receive up to 8 contacts with an occupational therapist (OT) interventionist over 4-months whereas caregivers in the attention control group will receive bi-monthly telephone contact (up to 8 contacts) in which education is provided and tailored to address unmet expressed informational needs of caregivers. Information concerning the value of activity and a list of activity ideas will also be provided. All dyads will be retested at 4-months from baseline (T2), main study endpoint, and 8-months from baseline (T3) by telephone to evaluate long-term effects. Interviewers will be masked to treatment assignment throughout the study.

FINDINGS/RESULTS:
1. For the primary outcome (Total score on the Neuropsychiatric Inventory (NPIC)), the TAP-VA Intervention Group (IG) improved by 38.1 points, while the Attention Control Group (ACG) declined by 1 point from baseline to intervention end (p=.013). The NPIC has a potential score range of 0 to 1704 (sum of 142 items, each with a potential score of 0 to12). However, after imputation, improvement for the IG was 33.6 points and the ACG improved 12.0 points (p=.07). Since the distribution of scores for each group was not normal, we applied a log transformation on the data after imputation and did not achieve significance (p=.173) in difference on the NPIC between the IG and ACG.
2. We next considered Number of Neuropsychiatric symptoms, of which there are 14 (Delusions, Hallucinations, Agitation, Aggression, Dysphoria, Anxiety, Euphoria, Apathy, Disinhibition, Irritability, Aberrant Motor Disturbance, Sleep Disorder, Appetite and Eating Disorders, and Aberrant Vocalizations). From baseline to end of intervention (4 months from baseline), the IG group improved by a mean reduction of 1.5 symptoms while the ACG achieved a 0.5 mean number of symptom reduction (p=0.024). No significant difference between groups was found at the 8-month post baseline interview (IG improved mean .9 symptoms and ACG mean of .7 symptoms (p=.587).
3. In considering differences between the IG and the ACG on each of the sub-ratings for neuropsychiatric symptoms, we found more improvement for the IG in Appetite and Eating Disorders at 4 months post baseline (p=.003), and in Irritability at 8 months post intervention (p=.047).
4. A post study follow-up call sought caregiver satisfaction with participation in the study. Both groups were equally highly satisfied with the study. The ACG received phone calls over the four month intervention period, during which a research assistant discussed with the caregiver chapters from the book "The 36-Hour Day" subtitled: "A Family Guide to Caring for People with Alzheimer's disease, Other Dementias, and Memory Loss in Later Life." Results showed improvement for both the IG and ACG; perhaps the ACG benefits, reflected in the high level of caregiver satisfaction in these caregivers, may provide an explanation for not having found stronger evidence of effectiveness of the TAP intervention.

IMPACT:
If proven efficacious, we hope to integrate TAP-VA into standard care practices within the VHA system as the first treatment choice to address NPS in Veterans with dementia living at home. This would transform the current paradigm of dementia care which relies on pharmacologic management. Eventually, TAP-VA investigators intend to meet with leadership from North Florida/South Georgia Veterans Health System and the Gainesville GRECC to discuss steps for implementing TAP-VA locally. Dr. Mann has also spoken with Dr. Ken Shay, National Office of Geriatrics and Extended Care, regarding further implementation of the TAP intervention within the VHA, potentially using a telehealth approach.

PUBLICATIONS:

Journal Articles

  1. 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. Journal of the American Geriatrics Society. 2018 Feb 1; 66(2):339-345.
  2. 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 geriatrics. 2013 Sep 23; 13(1):96.
Center Products

  1. Arthur PB, Gitlin LN, Mann WC. Addressing Attrition: A Hindering Aspect of Dementia Caregiving Trials. Cary, NC: Oxford Univ. Press, Inc.; 2014 Nov 1. 54 (Supplement 1). Available from: https://academic.oup.com/gerontologist/issue/54/Suppl_1.
  2. Arthur PB, Mann WC. A Question of Safety: Hazards of In-Home Data Collection. Cary, NC: Oxford Univ. Press, Inc.; 2013 Nov 1. 53. Available from: https://academic.oup.com/gerontologist/issue/53/S1.
  3. Arthur PB, Mann WC, Gitlin LN. Staying Blind in a Colorful World: Minimizing Collection Bias in Trials with Intensive Interventions. Cary, NC: Oxford Univ. Press, Inc.; 2013 Nov 1. 53. Available from: https://academic.oup.com/gerontologist/issue/53/S1.
Conference Presentations

  1. Howell TF, Winter SM, Mann WC, Gitlin LN, Piersol CV. TAP-VA: A non-pharmacological intervention addressing problem behaviors in veterans with dementia. Poster session presented at: Gerontological Society of America Annual Scientific Meeting; 2015 Nov 21; Orlando, FL.
  2. Lim Y, Gitlin LN, Vogel WB, Mann WC. The Cost-Effectiveness of Non-Pharmacologic, Behavioral Intervention in Veterans with Dementia: The Tailored Activity Program. Poster session presented at: Florida Occupational Therapy Association Annual Conference; 2014 Nov 8; Fort Myers, FL.
  3. Arthur PB, Mann WC. A Question of Safety: Hazards of In-Home Data Collection. Poster session presented at: Gerontological Society of America Annual Scientific Meeting; 2013 Nov 23; New Orleans, LA.
  4. Arthur PB, Mann WC, Gitlin L. Staying Blind in a Colorful World: Minimizing Collection Bias in Trials with Intensive Interventions. Poster session presented at: Gerontological Society of America Annual Scientific Meeting; 2013 Nov 21; New Orleans, LA.
  5. Arthur PB, Gitlin L, Mann WC. In progress: An efficacy trial of the tailored activity program for Veterans with dementia. Poster session presented at: Florida Occupational Therapy Association Annual Conference; 2012 Nov 2; Tampa, FL.


DRA: Mental, Cognitive and Behavioral Disorders, Aging, Older Veterans' Health and Care, Neurodegenerative Diseases
DRE: Treatment - Efficacy/Effectiveness Clinical Trial
Keywords: Outcomes - Patient, Quality of Life, Caregiving, Dementia, Family, Home Care
MeSH Terms: none

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