Clinical trial NCT02380703: Aggression Prevention Training for Caregivers of Persons With Dementia (APT)
Official title: Aggression Prevention Training for Caregivers of Persons With Dementia (APT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Pain
Alzheimer's Disease
Aggression
Depression
Interpersonal Relations
Keywords: aggression
dementia
Alzheimer's disease
pain
depression
caregiver
behavioral health
counseling
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2015-03-05
Enrollment: 239
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study will evaluate whether a home-based targeted education and skill training (Aggression Prevention Training or APT) will reduce aggression in persons with dementia (PWD) and pain/pain-related features more than usual care plus supportive telephone calls. Half of the participants will receive APT and half will receive supportive telephone calls.

Detailed description: Eighty percent of PWD have behavioral or psychological disturbances, including 40% that are aggressive behaviors. The prevalence of pain in PWD is about 60%, and it is a strong predictor of aggression. The biopsychosocial model of pain posits that pain is bidirectionally related to psychological factors (ie, depression) and social support factors (ie, quality of caregiver/PWD relationship) in addition to biological factors. Thus, depression and quality of the caregiver/PWD relationship can be seen as pain-related features. Caregivers are ideally suited to help address pain, depression, and the caregiver/PWD relationship, thus preventing the development of aggression; but they need tools to assist them in identifying and managing these symptoms.

Prior studies of aggression treatment have not examined using a preventive strategy to decrease incidence of aggression in persons with dementia (PWD). Almost all studies have examined use of pharmacologic interventions following development of aggression.This 5-year randomized controlled trial based on the Unmet Needs Model will focus on preventing aggression in PWD with pain and pain-related features by providing the caregiver with targeted education and skill training. PWD and their caregivers will be randomized to APT or to an enhanced usual primary care condition (EU-PC). APT will use active learning tools, including didactics, role-playing, and multimedia \[eg, books and digital versatile discs (DVDs)\] to educate and provide skill training for the caregiver. The 6-8 modules in the intervention will include 4 core modules that address 4 main aggression risk factors: a) recognizing pain, b) treating pain, c) increasing pleasant activities, and d) improving patient-caregiver communication. Caregivers can select 2 to 3 additional elective sessions; elective selection is guided by the needs of the dyad to further enhance skills related to these core topics. EU-PC provides the patient and caregiver educational materials on pain, notifies the primary care provider of the PWD's level of pain and depression, and provides 8 weekly supportive telephone calls to caregivers. PWD and caregiver outcomes will be collected at baseline, 3, 6 and 12 months.

Data analysis will include both univariate descriptive statistics and inferential statistics, including regression models, repeated measure modeling and Cox proportional hazards models.

Eligibility criteria: Inclusion Criteria:

1. Documented diagnosis of dementia
2. Clinically significant pain, depression, or caregiver/patient relationship difficulties (either self-report or caregiver proxy-report).
3. Receives care from Baylor College of Medicine Geriatric Medicine Associates or Alzheimer's Disease and Memory Disorders Center, or Kelsey Seybold Clinics
4. Has an informal caregiver willing to participate in the study who sees the patient at least 8 hours/week and at least twice/week
5. Speaks English
6. Lives within a 40-mile radius of the coordinating center

Exclusion Criteria:

1. Advanced dementia based on inability to complete the Mental Impairment Screen-Telephone Version or a Functional Assessment Staging Tool score \> 6.
2. History of aggression during the one month prior to screening or baseline
3. Resides in a long-term care facility

Primary outcomes:
measure: Number of Participants With Aggression as Per the Cohen Mansfield Agitation Inventory, Aggression Subscale
timeFrame: one year
Secondary outcomes:
measure: Caregiver Burden--Zarit Burden Interview
timeFrame: one year
measure: Positive Caregiving Attributes--Positive Aspects of Caregiving Scale
timeFrame: one year
measure: Behavior Problems--Revised Memory and Behavior Checklist
timeFrame: one year
measure: Pain--Philadelphia Geriatric Pain Intensity Scale (Overall Pain as Reported by the PWD)
timeFrame: one year
measure: Depression--Geriatric Depression Screen (GDS), Caregiver Version
timeFrame: one year
measure: Caregiver-Patient Relationship Quality--Mutuality Scale
timeFrame: one year
measure: Pain--Philadelphia Geriatric Pain Intensity Scale (Overall Pain as Reported by the Caregiver)
timeFrame: one year
Other outcomes:
Locations:
Study officials:
affiliation: Baylor College of Medicine
name: Mark E. Kunik, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sibley AA, Shrestha S, Lipovac-Dew M, Kunik ME. Examining Depression Symptoms With/Without Coexisting Anxiety Symptoms in Community-Dwelling Persons With Dementia. Am J Alzheimers Dis Other Demen. 2021 Jan-Dec;36:1533317521990267. doi: 10.1177/1533317521990267.