Aggression Prevention Training for Caregivers of Persons With Dementia (APT)

Not Applicable

Completed

• Conditions: Aggression; Interpersonal Relations; Pain; Alzheimer's Disease; Dementia; Depression
• Interventions: Behavioral: Aggression Prevention Training (APT); Other: Enhanced Usual Primary Care (EU-PC)

• Registration Number: NCT02380703
• Lead Sponsor: Baylor College of Medicine

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.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2015-02-05
• Study First Submitted: 2015-03-01
• Study First Submitted QC: 2015-03-04
• Study First Posted: 2015-03-05
• Primary Completion: 2018-10-23
• Study Completion: 2018-10-23
• Results First Submitted: 2020-08-31
• Status Verified: 2020-11
• Results First Submitted QC: 2020-11-13
• Last Update Submitted: 2020-11-13
• Results First Posted: 2020-12-11
• Last Update Posted: 2020-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 239

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Aggression Prevention Training (APT)	Aggression Prevention Training (APT)	APT will use active learning tools, including didactics, role-playing, and multimedia (eg, books and 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. Sessions will take place in the patient's home.
Enhanced Usual Primary Care (EU-PC)	Enhanced Usual Primary Care (EU-PC)	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Aggression as Per the Cohen Mansfield Agitation Inventory, Aggression Subscale	one year	Aggression is measured on a 7-point Likert scale for frequency and a 5-point Likert scale for disruptiveness. Aggression is considered present if a participant scores over one on both frequency (more than never) and disruptiveness (at least a little) on any of 13 aggressive behaviors, including spitting, verbal aggression, hitting, kicking, grabbing, pushing, throwing, biting, scratching, hurting self/others, destroying property, or making inappropriate verbal or physical sexual advances.

Secondary Outcome Measures

Name	Time	Method
Caregiver Burden--Zarit Burden Interview	one year	The Zarit Burden Interview is a 22-item instrument measuring perceived impact of caregiving on the caregiver's financial status, physical status, physical health, emotional health, and social activities. Questions are answered on a 5-point Likert-type scale (0=never, 4=nearly always). The total scale score ranges from 0-88.
Positive Caregiving Attributes--Positive Aspects of Caregiving Scale	one year	The 9-item Positive Aspects of Caregiving Scale presents statements about a caregiver's mental or affective state in the context of the caregiving experience. Responses are provided on a 5-point agree/disagree scale and designed to assess perception of benefits within the caregiving context, such as feeling useful, feeling appreciated, and finding meaning. Higher scores (range 9-45) represent more positive appraisals.
Depression--Geriatric Depression Screen (GDS), Caregiver Version	one year	The 30-item GDS will be administered to the caregiver to measure depression. Items are answered with Yes/No. Total score ranges from 0-30. A score of 11 or greater is a possible indicator of depression.
Behavior Problems--Revised Memory and Behavior Checklist	one year	Revised Memory and Behavior Checklist (RMBCL) is a 24-item informant-based measure of observable behavior problems in PWD, including memory-related, disruptive, and depressive behaviors. Scores are computed for the presence/absence of each problem first and then for caregiver "reaction" or the extent to which caregivers were bothered or distressed by each behavior (0-4). Total score is the sum of reaction scores for all endorsed behaviors. Possible range is 0-96. A higher score indicates a worse outcome.
Pain--Philadelphia Geriatric Pain Intensity Scale (Overall Pain as Reported by the Caregiver)	one year	The Philadelphia Geriatric Pain Intensity Scale will be administered to the caregiver to measure caregiver report of PWD pain. It consists of 4 items assessing the extent to which the the caregiver feels the PWD has been bothered by pain over the past several weeks--at present, when pain was at its worst, when pain was at its least, and overall. These items are rated on a 0- to 5-point Likert scale (not at all to extremely). A fifth item asks for number of days per week that pain was really bad, and a sixth asks for a rating of how much pain has interfered with day-to-day activities. We report only on the item about overall pain.
Pain--Philadelphia Geriatric Pain Intensity Scale (Overall Pain as Reported by the PWD)	one year	The Philadelphia Geriatric Pain Intensity Scale will be administered to the PWD to measure pain. It consists of 4 items assessing the extent to which the PWD has been bothered by pain over the past several weeks--at present, when pain was at its worst, when pain was at its least, and overall. These items are rated on a 0- to 5-point Likert scale (not at all to extremely). A fifth item asks for number of days per week that pain was really bad, and a sixth asks for a rating of how much pain has interfered with day-to-day activities. We report only on the item about overall pain.
Caregiver-Patient Relationship Quality--Mutuality Scale	one year	The Mutuality Scale and is a 15-item instrument measuring the positive quality of the relationship between caregiver and care receiver. Questions are answered by the caregiver on a 5-point Likert-type scale (0=never, 4=a great deal). Its 4 subscales represent domains of shared values, affective closeness, shared pleasurable activities and reciprocity. The total score ranges from 0-4 and is the sum of individual items divided by the number of items answered. High scores indicate a relationship characterized by communication, shared pleasurable activities, common values, and reciprocity.