Preventing Aggression In Veterans With Dementia (PAVED) - Telephone Sub-Study With Rural Veterans (PAVED-T)
|ClinicalTrials.gov Identifier: NCT01385007|
Recruitment Status : Unknown
Verified June 2011 by Michael Debakey Veterans Affairs Medical Center.
Recruitment status was: Not yet recruiting
First Posted : June 29, 2011
Last Update Posted : June 29, 2011
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 or disease||Intervention/treatment||Phase|
|Dementia Pain||Behavioral: Preventing Aggression in Veterans with Dementia (PAVeD)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Preventing Aggression In Veterans With Dementia (PAVED) - Telephone Sub-Study With Rural Veterans|
|Study Start Date :||August 2011|
|Estimated Primary Completion Date :||December 2012|
|Estimated Study Completion Date :||December 2013|
Behavioral: Preventing Aggression in Veterans with Dementia (PAVeD)
- Incidence of Aggression [ Time Frame: 3 months and 6 months post-intervention ]Evaluate the incidence of aggression different than expected in the Telephone PAVeD subjects