Preventing Aggression in Veterans With Dementia

Pain Clinical Trial

— PAVeD  

Official title:

Preventing Aggression in Veterans With Dementia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01325714
• Other study ID #: IIR 09-351
• Status: Completed
• Phase: Phase 3
• First received: March 28, 2011
• Last updated: May 17, 2016
• Start date: May 2011
• Est. completion date: September 2015

Study information

• Verified date: May 2016
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 203
• Est. completion date: September 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 60 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Aggression
• Dementia
• Pain

Intervention

Behavioral:
• PAVeD Intervention
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.
• Enhanced Usual Care
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.

Locations

Country	Name	City	State
United States	Michael E. DeBakey VA Medical Center, Houston, TX	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. R — View 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: 10.1177/15 — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Three Months, Six Months, Twelve Months Post Intervention	No
Secondary	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	Baseline, 3 months, 6 months, and 12 months	No
Secondary	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.	Baseline, 3, 6, and 12 months	No
Secondary	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.	Baseline, 3, 6, and 12 months.	No
Secondary	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.	Baseline, 3, 6, and 12 months	No
Secondary	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.	Baseline, 3, 6, and 12 months	No
Secondary	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.	Baseline, 0, 3, 6, 12 months	No
Secondary	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.	Baseline, 3, 6, 12 months	No
Secondary	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.	Baseline, 3, 6, 12 months	No