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

Pain Clinical Trial

Official title: Preventing Aggression In Veterans With Dementia (PAVED) - Telephone Sub-Study With Rural Veterans

Status Not yet recruiting

Clinical Trial Summary

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.

Clinical Trial Description

n/a

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Aggression
• Dementia
• Pain

• NCT number: NCT01385007
• Study type: Interventional
• Source: Michael Debakey Veterans Affairs Medical Center
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 2011
• Completion date: December 2013