search
Back to results

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
Michael E. DeBakey VA Medical Center
About
Eligibility
Locations
Outcomes
Full info

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

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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.

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

    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
    search

    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

    We'll reach out to this number within 24 hrs