Preventing Aggression In Veterans With Dementia (PAVED) - Telephone Sub-Study With Rural Veterans (PAVED-T)

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:

1. Describe the feasibility and acceptability of the PAVeD-Telephone intervention (number of dyads recruited and completing the study) by rural Veterans and their caregivers.
2. Describe the preliminary outcomes (aggression, depression, Veteran/caregiver relationship quality, pleasant events, caregiver burden, and pain) at baseline, 3 and 6 months.
3. 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.

Study Overview

• Status: Unknown
• Conditions: Pain; Dementia
• Intervention / Treatment: Behavioral: Preventing Aggression in Veterans with Dementia (PAVeD)

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. diagnosis of dementia
2. pain symptoms documented by the HBPC staff
3. residence in a VA designated rural area of Lufkin or Conroe
4. presence of a caregiver
5. Enrolled in Home Based Primary Care at Michael E DeBakey VA Medical Center

Exclusion Criteria:

1. 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
2. score of 6 or greater on the Functional Assessment Staging (FAST) scale
3. inability to complete by phone a cognitive screening assessment (Telephone Interview for Cognitive Status) or the Philadelphia Geriatric Pain Intensity Scale.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Aggression	Evaluate the incidence of aggression different than expected in the Telephone PAVeD subjects	3 months and 6 months post-intervention

Collaborators and Investigators

• Sponsor: Michael E. DeBakey VA Medical Center
• Collaborators: South Central VA Mental Illness Research, Education & Clinical Center

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (Anticipated): December 1, 2012
• Study Completion (Anticipated): December 1, 2013

Study Registration Dates

• First Submitted: June 24, 2011
• First Submitted That Met QC Criteria: June 28, 2011
• First Posted (Estimate): June 29, 2011

Study Record Updates

• Last Update Posted (Estimate): June 29, 2011
• Last Update Submitted That Met QC Criteria: June 28, 2011
• Last Verified: June 1, 2011

More Information

Terms related to this study

• Keywords: Pain; Veterans; Dementia; Aggression; Rural; residence in a VA designated rural area; presence of a caregiver
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Aggression; Dementia
• Other Study ID Numbers: H-28155