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

NCT01385007 | Unknown

• 1 other identifier: H-28155
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief 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. 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. 2.Describe the preliminary outcomes (aggression, depression, Veteran/caregiver relationship quality, pleasant events, caregiver burden, and pain) at baseline, 3 and 6 months.
3. 3.Understand the cultural beliefs and practices of this population and the impact of the intervention.

Conditions

Dementia; Pain

Keywords

Rural; Veterans; Dementia; Pain; Aggression; residence in a VA designated rural area; presence of a caregiver

Outcome Measures

Primary Outcomes (1)

• Incidence of Aggression

  Evaluate the incidence of aggression different than expected in the Telephone PAVeD subjects

  3 months and 6 months post-intervention

Interventions

Preventing Aggression in Veterans with Dementia (PAVeD) BEHAVIORAL

PAVeD-Telephone consists of three components: pain-management strategies, improvement of patient-collateral communication skills, and behavioral activation through increased pleasant activity planning. The intervention will be primarily geared toward the caregiver; but patients may be involved in some modules, depending on their dementia severity and willingness. The goal of the sessions is to prevent aggression in veterans with dementia. The sessions will include didactics, skill-building, and discussion. Participants will also be provided a copy of the book, Pain Management for Older Adults: A Self-help Guide, as an additional resource for optional reading on the topics covered in the intervention. The intervention is proposed to include six to eight sessions of weekly treatments, lasting 30 minutes to 45 minutes, specifically developed to address the recognition and management of pain in persons with dementia.

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

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

MeSH Terms

Conditions

Dementia; Pain; Aggression

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior; Social Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED

Study Record Dates

• First Submitted: June 24, 2011
• First Posted: June 29, 2011
• Study Start: August 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2013
• Last Updated: June 29, 2011

Record last verified: 2011-06