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Trial record 48 of 1598 for:    veterans affairs medical center

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

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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
Sponsor:
Collaborator:
South Central VA Mental Illness Research, Education & Clinical Center
Information provided by:
Michael Debakey Veterans Affairs Medical Center

Tracking Information
First Submitted Date  ICMJE June 24, 2011
First Posted Date  ICMJE June 29, 2011
Last Update Posted Date June 29, 2011
Study Start Date  ICMJE August 2011
Estimated Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 28, 2011)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Preventing Aggression In Veterans With Dementia (PAVED) - Telephone Sub-Study With Rural Veterans
Official Title  ICMJE Preventing Aggression In Veterans With Dementia (PAVED) - Telephone Sub-Study With Rural Veterans
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. 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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Dementia
  • Pain
Intervention  ICMJE Behavioral: Preventing Aggression in Veterans with Dementia (PAVeD)
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.
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 28, 2011)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2013
Estimated Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01385007
Other Study ID Numbers  ICMJE H-28155
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Michael Mallen, PhD, Michael E DeBakey Veterans Affairs Medical Center
Study Sponsor  ICMJE Michael Debakey Veterans Affairs Medical Center
Collaborators  ICMJE South Central VA Mental Illness Research, Education & Clinical Center
Investigators  ICMJE Not Provided
PRS Account Michael Debakey Veterans Affairs Medical Center
Verification Date June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP