Preventing Aggression In Veterans With Dementia (PAVED) - Telephone Sub-Study With Rural Veterans (PAVED-T)
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Purpose
Aggression, a common symptom in persons with dementia, is linked with multiple treatable etiologies such as pain, depression, caregiver burden, and caregiver relationships. Pain, the main predictor of aggression, is a common symptom that is inadequately assessed and treated in persons with dementia. The main treatment for aggression is antipsychotic medications that are ineffective, costly, and possess considerable adverse side effects. There is a need to test psychosocial interventions that address treatable causes of aggression. Preliminary data suggest the potential utility of Preventing Aggression in Veterans with Dementia (PAVeD), an evidence-based psychoeducational intervention aimed to prevent aggression, with urban dwelling Veterans. PAVeD, an in-home intervention that requires significant clinician time and expense has yet to be evaluated in a rural culture with Veterans who are in poorer health compared to urban Veterans.
The purpose of this intervention demonstration pilot study is to pilot test and evaluate the PAVeD-Telephone intervention. Twenty rural Veterans with dementia and pain and their caregivers from the Home Based Primary Care (HBPC) Program will be invited to participate. Clinical activities directed toward caregivers are supported by policies and procedures set forth by the Veterans Health Administration (Appendix A). Mixed-methods will be used to collect data using semi-structured interviews and standardized data collection measures suitable for persons with dementia and their caregivers. The interviews go beyond an evaluation of the outcomes by exploring how the intervention was experienced by the dyad.
The specific aims of the study are to:
- Describe the feasibility and acceptability of the PAVeD-Telephone intervention (number of dyads recruited and completing the study) by rural Veterans and their caregivers.
- Describe the preliminary outcomes (aggression, depression, Veteran/caregiver relationship quality, pleasant events, caregiver burden, and pain) at baseline, 3 and 6 months.
- Understand the cultural beliefs and practices of this population and the impact of the intervention.
The PAVeD-Telephone intervention is an innovative approach to shift the paradigm of treating aggression with antipsychotic medications. This study is consistent with the goals of the South Central Mental Illness Research Education and Clinical Center (MIRECC) to improve evidence-based practices in rural Veterans and their caregivers. The next step in this program of research is to submit a Health Services Research and Development Service (HSR&D) application for pilot funding to further develop and test the telephone-based intervention and an appropriate control condition.
| Condition | Intervention |
|---|---|
|
Dementia Pain |
Behavioral: Preventing Aggression in Veterans with Dementia (PAVeD) |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Preventing Aggression In Veterans With Dementia (PAVED) - Telephone Sub-Study With Rural Veterans |
- Incidence of Aggression [ Time Frame: 3 months and 6 months post-intervention ] [ Designated as safety issue: No ]Evaluate the incidence of aggression different than expected in the Telephone PAVeD subjects
| Estimated Enrollment: | 40 |
| Study Start Date: | August 2011 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
-
Behavioral: Preventing Aggression in Veterans with Dementia (PAVeD)
Eligibility| Ages Eligible for Study: | 65 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- diagnosis of dementia
- pain symptoms documented by the HBPC staff
- residence in a VA designated rural area of Lufkin or Conroe
- presence of a caregiver
- Enrolled in Home Based Primary Care at Michael E DeBakey VA Medical Center
Exclusion Criteria:
- display of aggression (spitting, cursing/verbal aggression, hitting, kicking, grabbing, pushing, throwing, biting, scratching, hurting self/others, tearing things/destroying property, making inappropriate verbal sexual advances, or making inappropriate physical sexual advances) in the past year
- score of 6 or greater on the Functional Assessment Staging (FAST) scale
- inability to complete by phone a cognitive screening assessment (Telephone Interview for Cognitive Status) or the Philadelphia Geriatric Pain Intensity Scale.
Contacts and Locations
More Information
No publications provided
| Responsible Party: | Michael Mallen, PhD, Michael E DeBakey Veterans Affairs Medical Center |
| ClinicalTrials.gov Identifier: | NCT01385007 History of Changes |
| Other Study ID Numbers: | H-28155 |
| Study First Received: | June 24, 2011 |
| Last Updated: | June 28, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Michael Debakey Veterans Affairs Medical Center:
|
Rural Veterans Dementia Pain |
Aggression residence in a VA designated rural area presence of a caregiver |
Additional relevant MeSH terms:
|
Aggression Dementia Behavioral Symptoms Brain Diseases |
Central Nervous System Diseases Nervous System Diseases Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders |
ClinicalTrials.gov processed this record on May 22, 2013