Preventing Aggression In Veterans With Dementia (PAVED) - Telephone Sub-Study With Rural Veterans (PAVED-T)
Primary Purpose
Dementia, Pain
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Preventing Aggression in Veterans with Dementia (PAVeD)
Sponsored by
About this trial
This is an interventional prevention trial for Dementia focused on measuring Rural, Veterans, Dementia, Pain, Aggression, residence in a VA designated rural area, presence of a caregiver
Eligibility Criteria
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.
Sites / Locations
Outcomes
Primary Outcome Measures
Incidence of Aggression
Evaluate the incidence of aggression different than expected in the Telephone PAVeD subjects
Secondary Outcome Measures
Full Information
NCT ID
NCT01385007
First Posted
June 24, 2011
Last Updated
June 28, 2011
Sponsor
Michael E. DeBakey VA Medical Center
Collaborators
South Central VA Mental Illness Research, Education & Clinical Center
1. Study Identification
Unique Protocol Identification Number
NCT01385007
Brief Title
Preventing Aggression In Veterans With Dementia (PAVED) - Telephone Sub-Study With Rural Veterans
Acronym
PAVED-T
Official Title
Preventing Aggression In Veterans With Dementia (PAVED) - Telephone Sub-Study With Rural Veterans
Study Type
Interventional
2. Study Status
Record Verification Date
June 2011
Overall Recruitment Status
Unknown status
Study Start Date
August 2011 (undefined)
Primary Completion Date
December 2012 (Anticipated)
Study Completion Date
December 2013 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Michael E. DeBakey VA Medical Center
Collaborators
South Central VA Mental Illness Research, Education & Clinical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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:
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia, Pain
Keywords
Rural, Veterans, Dementia, Pain, Aggression, residence in a VA designated rural area, presence of a caregiver
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Preventing Aggression in Veterans with Dementia (PAVeD)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Incidence of Aggression
Description
Evaluate the incidence of aggression different than expected in the Telephone PAVeD subjects
Time Frame
3 months and 6 months post-intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
12. IPD Sharing Statement
Learn more about this trial
Preventing Aggression In Veterans With Dementia (PAVED) - Telephone Sub-Study With Rural Veterans
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