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Preventing Aggression in Veterans With Dementia (PAVeD)

Primary Purpose

Dementia, Aggression, Pain

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
PAVeD Intervention
Enhanced Usual Care
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Dementia

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Patients will be eligible to participate in the study if they meet the following criteria:

  • have a documented diagnosis of dementia
  • receive primary care from the VA
  • reside outside a long-term care facility
  • live within 45 minutes of the MEDVAMC
  • have mild-to-moderate dementia
  • have no history of aggression in the past year
  • have no evidence of aggression on the CMAI at baseline (i.e., do not score 2 or higher on both frequency and disruptiveness for any of 13 behaviors listed).

  • have a caregiver who is directly involved with the patient:

    • at least 8 hours per week
    • sees the patient at least twice a week
    • and speaks English
  • report clinically significant pain (either directly or through the caregiver as a proxy)

Exclusion Criteria:

Patients will be excluded if they have had history of aggression in the past year

  • The investigators will administer the aggression subscale of the Cohen-Mansfield Agitation Inventory (CMAI)

  • Aggression will be considered present if any of the following items are endorsed as having occurred over the prior year:

    • 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

Participants that scored 2 or higher for both frequency and disruptiveness on any of the 13 behaviors listed on the CMAI at baseline were considered aggressive and were excluded from the study.

Sites / Locations

  • Michael E. DeBakey VA Medical Center, Houston, TX

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm 1: PAVeD Intervention

Arm 2: Enhanced Usual Care

Arm Description

In the experimental arm, the caregiver will receive six to eight 45-minute visits to teach caregiver about pain and memory problems. The person with dementia will also be able to learn from these visits. These visits will take place over three months.

In the comparison arm, the caregiver will receive information in the mail about memory problems and pain; and the caregiver will receive eight short telephone calls to check on how the person with dementia is doing.

Outcomes

Primary Outcome Measures

Number of Participants With Aggression as Determined by the Cohen-Mansfield Agitation Inventory (Aggression Subscale)
The CMAI lists 13 behaviors (2 verbal and 11 nonverbal) and for each behavior the participant indicates how frequently the behavior occurs (1-5, higher values = greater frequency) and how disruptive the behavior is (1-5, higher values = greater disruptiveness). For any given behavior, if a participant scored a 2 or higher on BOTH frequency (i.e., it occurred "less than once a week" or more often) and disruptiveness (i.e., it was "a little" disruptive or more), he/she was considered aggressive. Overall aggression takes into account all 13 behaviors, whereas verbal aggression only pertains to two behaviors and non-verbal aggression pertains to 11 behaviors. One is considered verbally aggressive if he/she responds with a 2 or higher on both frequency and disruptiveness for either of the two verbal behaviors. One is considered non-verbally aggressive if he/she responds with a 2 or higher on both frequency and disruptiveness for any of the 11 non-verbal behaviors.

Secondary Outcome Measures

Caregiver-Reported Worst Pain
This is one item on the Philadelphia Pain Intensity Scale. One item with scores from 0 to 5, where 0 = no pain, 1 = little pain, 2 = moderate pain, 3 = quite bad pain, 4 = very bad pain, 5 = the pain is almost unbearable. Higher scores = greater pain severity
Patient-reported Worst Pain.
This is one item on the Philadelphia Pain Intensity Scale. One item on a 0-5 scale, where 0 = no pain, 1 = little pain, 2= moderate pain, 3 = quite bad pain, 4 = very bad pain, 5 = the pain is almost unbearable. Higher scores = greater pain severity.
Caregiver Reported Overall Pain Over the Last Several Weeks
This is one item on the Philadelphia Pain Intensity Scale. One item on a 0-5 scale, where 0 = no pain, 1 = little pain, 2= moderate pain, 3 = quite bad pain, 4 = very bad pain, 5 = the pain is almost unbearable. Higher scores = greater pain severity.
Patient-reported Overall Pain Over the Last Several Weeks
This is one item on the Philadelphia Pain Intensity Scale. One item on a 0-5 scale, where 0 = no pain, 1 = little pain, 2= moderate pain, 3 = quite bad pain, 4 = very bad pain, 5 = the pain is almost unbearable. Higher scores = greater pain severity.
Depression
Geriatric Depression Scale. 30 item scale with response options of yes = 1 and no = 0 to each item. Total GDS scores range from 0 to 30, with greater scores indicating greater depression.
Pleasant Events - Short Form - Alzheimer's Disease
The frequency of engagement in pleasant events, according to the Pleasant Events Schedule - Alzheimer's Disease. For each of 20 events, participants answered the frequency (0 = not at all, 1 = 1-6 times, 2 = 7+ times) they engaged in the event and whether they enjoyed the event (1 = yes, 0 = no). For each item, frequency x enjoyment were multiplied. Then scores for each of the 20 items were added together. The possible range of scores on the PES frequency of engagement in pleasant events is from 0 - 40, with higher scores indicating more frequent engagement in pleasant events.
Caregiver Burden
Caregiver-reported burden, according to the Burden Inventory. 22 items are responded to on a 0-4 scale where 0 = never, 1 = rarely, 2 = sometimes, 3 = quite frequently, and 4 = nearly always. Scores are then summed so that the total range is from 0 to 88. Higher scores indicate greater caregiver burden.
Caregiver-perceived Mutuality
Caregiver-Perceived Total Mutuality (with patient), based on the Mutuality Scale. Fifteen items about the caregivers' relationship with the patient with dementia were responded to on a 0-4 scale, where 0 = not at all, 1 = a little, 2 = some, 3 = quite a bit, and 4 = a great deal. responses to all 15 items were averaged, so total scores range from 0-4, with higher values indicating greater mutuality.

Full Information

First Posted
March 28, 2011
Last Updated
May 19, 2016
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT01325714
Brief Title
Preventing Aggression in Veterans With Dementia
Acronym
PAVeD
Official Title
Preventing Aggression in Veterans With Dementia
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study tests whether education about memory and pain might help to prevent aggression in persons with dementia who have pain. The overall goal of this intervention is to reduce the risk of aggressive behavior by improving several areas of patient life that are known causes of aggression: pain, depression, lack of pleasurable activities, caregiver stress and difficulty in caregiver-patient communication.
Detailed Description
Dementia is known primarily for its effects on memory, however, eighty percent of persons with dementia also have behavioral disturbances. This is often not addressed, leading to increased use of nursing homes, higher incidence of injury (both patient and caregiver) and the use of tranquilizing medications. Pain is one of the strongest predictors of aggression. The prevalence of pain in persons with dementia is known to be about 50%. Untreated pain is associated with significant negative outcomes, including increased health care use, inactivity and isolation. The investigators aim to determine whether outcome differences exist between active intervention and control conditions in relation to the occurrence of aggressive behavior, pain and depression, and its impact on pleasant activities, caregiver burden, quality of caregiver-patient relationship, antipsychotic use, health-service use, injuries to patient and caregiver, and nursing home placement. The active intervention, Preventing Aggression in Veterans with Dementia (PAVeD), is a family caregiver-focused, home-based intervention that uses psychoeducational and behavioral approaches to help reduce the risk of aggressive behavior in persons with dementia. The objective of PAVeD is to improve several areas of patient life that are known causes of aggression: pain and distress (including mood problems), lack of pleasurable activities, and difficulty in patient-caregiver communication that may negatively affect relationship quality and caregivers' recognition of pain.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia, Aggression, Pain

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
203 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1: PAVeD Intervention
Arm Type
Experimental
Arm Description
In the experimental arm, the caregiver will receive six to eight 45-minute visits to teach caregiver about pain and memory problems. The person with dementia will also be able to learn from these visits. These visits will take place over three months.
Arm Title
Arm 2: Enhanced Usual Care
Arm Type
Active Comparator
Arm Description
In the comparison arm, the caregiver will receive information in the mail about memory problems and pain; and the caregiver will receive eight short telephone calls to check on how the person with dementia is doing.
Intervention Type
Behavioral
Intervention Name(s)
PAVeD Intervention
Intervention Description
In the PAVeD Intervention, the caregiver will receive six to eight 45-minute visits to teach caregiver about pain and memory problems. The person with dementia will also be able to learn from these visits. These visits will take place over three months.
Intervention Type
Behavioral
Intervention Name(s)
Enhanced Usual Care
Intervention Description
In Enhanced Usual Care, the caregiver will receive information in the mail about memory problems and pain; and the caregiver will receive eight short telephone calls to check on how the person with dementia is doing. Primary Care providers will be notified through electronic medical records about any significant behavioral problems or pain.
Primary Outcome Measure Information:
Title
Number of Participants With Aggression as Determined by the Cohen-Mansfield Agitation Inventory (Aggression Subscale)
Description
The CMAI lists 13 behaviors (2 verbal and 11 nonverbal) and for each behavior the participant indicates how frequently the behavior occurs (1-5, higher values = greater frequency) and how disruptive the behavior is (1-5, higher values = greater disruptiveness). For any given behavior, if a participant scored a 2 or higher on BOTH frequency (i.e., it occurred "less than once a week" or more often) and disruptiveness (i.e., it was "a little" disruptive or more), he/she was considered aggressive. Overall aggression takes into account all 13 behaviors, whereas verbal aggression only pertains to two behaviors and non-verbal aggression pertains to 11 behaviors. One is considered verbally aggressive if he/she responds with a 2 or higher on both frequency and disruptiveness for either of the two verbal behaviors. One is considered non-verbally aggressive if he/she responds with a 2 or higher on both frequency and disruptiveness for any of the 11 non-verbal behaviors.
Time Frame
Three Months, Six Months, Twelve Months Post Intervention
Secondary Outcome Measure Information:
Title
Caregiver-Reported Worst Pain
Description
This is one item on the Philadelphia Pain Intensity Scale. One item with scores from 0 to 5, where 0 = no pain, 1 = little pain, 2 = moderate pain, 3 = quite bad pain, 4 = very bad pain, 5 = the pain is almost unbearable. Higher scores = greater pain severity
Time Frame
Baseline, 3 months, 6 months, and 12 months
Title
Patient-reported Worst Pain.
Description
This is one item on the Philadelphia Pain Intensity Scale. One item on a 0-5 scale, where 0 = no pain, 1 = little pain, 2= moderate pain, 3 = quite bad pain, 4 = very bad pain, 5 = the pain is almost unbearable. Higher scores = greater pain severity.
Time Frame
Baseline, 3, 6, and 12 months
Title
Caregiver Reported Overall Pain Over the Last Several Weeks
Description
This is one item on the Philadelphia Pain Intensity Scale. One item on a 0-5 scale, where 0 = no pain, 1 = little pain, 2= moderate pain, 3 = quite bad pain, 4 = very bad pain, 5 = the pain is almost unbearable. Higher scores = greater pain severity.
Time Frame
Baseline, 3, 6, and 12 months.
Title
Patient-reported Overall Pain Over the Last Several Weeks
Description
This is one item on the Philadelphia Pain Intensity Scale. One item on a 0-5 scale, where 0 = no pain, 1 = little pain, 2= moderate pain, 3 = quite bad pain, 4 = very bad pain, 5 = the pain is almost unbearable. Higher scores = greater pain severity.
Time Frame
Baseline, 3, 6, and 12 months
Title
Depression
Description
Geriatric Depression Scale. 30 item scale with response options of yes = 1 and no = 0 to each item. Total GDS scores range from 0 to 30, with greater scores indicating greater depression.
Time Frame
Baseline, 3, 6, and 12 months
Title
Pleasant Events - Short Form - Alzheimer's Disease
Description
The frequency of engagement in pleasant events, according to the Pleasant Events Schedule - Alzheimer's Disease. For each of 20 events, participants answered the frequency (0 = not at all, 1 = 1-6 times, 2 = 7+ times) they engaged in the event and whether they enjoyed the event (1 = yes, 0 = no). For each item, frequency x enjoyment were multiplied. Then scores for each of the 20 items were added together. The possible range of scores on the PES frequency of engagement in pleasant events is from 0 - 40, with higher scores indicating more frequent engagement in pleasant events.
Time Frame
Baseline, 0, 3, 6, 12 months
Title
Caregiver Burden
Description
Caregiver-reported burden, according to the Burden Inventory. 22 items are responded to on a 0-4 scale where 0 = never, 1 = rarely, 2 = sometimes, 3 = quite frequently, and 4 = nearly always. Scores are then summed so that the total range is from 0 to 88. Higher scores indicate greater caregiver burden.
Time Frame
Baseline, 3, 6, 12 months
Title
Caregiver-perceived Mutuality
Description
Caregiver-Perceived Total Mutuality (with patient), based on the Mutuality Scale. Fifteen items about the caregivers' relationship with the patient with dementia were responded to on a 0-4 scale, where 0 = not at all, 1 = a little, 2 = some, 3 = quite a bit, and 4 = a great deal. responses to all 15 items were averaged, so total scores range from 0-4, with higher values indicating greater mutuality.
Time Frame
Baseline, 3, 6, 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients will be eligible to participate in the study if they meet the following criteria: have a documented diagnosis of dementia receive primary care from the VA reside outside a long-term care facility live within 45 minutes of the MEDVAMC have mild-to-moderate dementia have no history of aggression in the past year have no evidence of aggression on the CMAI at baseline (i.e., do not score 2 or higher on both frequency and disruptiveness for any of 13 behaviors listed). have a caregiver who is directly involved with the patient: at least 8 hours per week sees the patient at least twice a week and speaks English report clinically significant pain (either directly or through the caregiver as a proxy) Exclusion Criteria: Patients will be excluded if they have had history of aggression in the past year The investigators will administer the aggression subscale of the Cohen-Mansfield Agitation Inventory (CMAI) Aggression will be considered present if any of the following items are endorsed as having occurred over the prior year: 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 Participants that scored 2 or higher for both frequency and disruptiveness on any of the 13 behaviors listed on the CMAI at baseline were considered aggressive and were excluded from the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark E. Kunik, MD MPH
Organizational Affiliation
Michael E. DeBakey VA Medical Center, Houston, TX
Official's Role
Principal Investigator
Facility Information:
Facility Name
Michael E. DeBakey VA Medical Center, Houston, TX
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26035086
Citation
Fowler JH, Dannecker K, Stanley M, Wilson N, Snow AL, Kunik ME. Preventing aggression and other secondary features of dementia in elderly persons: Three case studies. Bull Menninger Clin. 2015 Spring;79(2):95-115. doi: 10.1521/bumc.2015.79.2.95.
Results Reference
result
PubMed Identifier
22467413
Citation
Bradford A, Shrestha S, Snow AL, Stanley MA, Wilson N, Hersch G, Kunik ME. Managing pain to prevent aggression in people with dementia: a nonpharmacologic intervention. Am J Alzheimers Dis Other Demen. 2012 Feb;27(1):41-7. doi: 10.1177/1533317512439795.
Results Reference
result
PubMed Identifier
25107934
Citation
Breland JY, Barrera TL, Snow AL, Sansgiry S, Stanley MA, Wilson N, Amspoker AB, Kunik ME. Correlates of pain intensity in community-dwelling individuals with mild to moderate dementia. Am J Alzheimers Dis Other Demen. 2015 May;30(3):320-5. doi: 10.1177/1533317514545827. Epub 2014 Aug 7.
Results Reference
result
PubMed Identifier
26955380
Citation
Li J, Snow AL, Wilson N, Stanley MA, Morgan RO, Sansgiry S, Kunik ME. The Quality of Pain Treatment in Community-Dwelling Persons with Dementia. Dement Geriatr Cogn Dis Extra. 2015 Dec 5;5(3):459-70. doi: 10.1159/000441717. eCollection 2015 Sep-Dec.
Results Reference
result
PubMed Identifier
32026743
Citation
Amspoker AB, Snow AL, Renn BN, Block P, Pickens S, Morgan RO, Kunik ME. Patient Versus Informal Caregiver Proxy Reports of Pain Interference in Persons With Dementia. J Appl Gerontol. 2021 Apr;40(4):414-422. doi: 10.1177/0733464820902632. Epub 2020 Feb 6.
Results Reference
derived

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Preventing Aggression in Veterans With Dementia

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