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

• Sponsor: Baylor College of Medicine (Other)
• Overall Status: Completed
• CT.gov ID: NCT02380703
• Collaborator: National Institute of Nursing Research (NINR) (NIH)
• Enrollment: 239
• Arms: 2
• Actual Duration (Months): 44.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dementia; Pain; Alzheimer's Disease; Aggression; Depression; Interpersonal Relations	Behavioral: Aggression Prevention Training (APT); Other: Enhanced Usual Primary Care (EU-PC)	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 239 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Aggression Prevention Training for Caregivers of Persons With Dementia (APT)
• Actual Study Start Date: Feb 5, 2015
• Actual Primary Completion Date: Oct 23, 2018
• Actual Study Completion Date: Oct 23, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Behavioral: Aggression Prevention Training (APT)
Placebo Comparator: 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.	Other: Enhanced Usual Primary Care (EU-PC)

Outcome Measures

Primary Outcome Measures

1. 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

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Baylor College of Medicine
• National Institute of Nursing Research (NINR)

Investigators

• Principal Investigator: Mark E. Kunik, M.D., Ph.D., Baylor College of Medicine

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jun 3, 2020

More Information

Publications

None provided.

• Responsible Party: Mark Kunik, M.D., M.P.H., Professor, Baylor College of Medicine
• ClinicalTrials.gov Identifier: NCT02380703
• Other Study ID Numbers: H-33720; R01NR014657-01A1
• First Posted: Mar 5, 2015
• Last Update Posted: Dec 11, 2020
• Last Verified: Nov 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Mark Kunik, M.D., M.P.H., Professor, Baylor College of Medicine: aggression; dementia; Alzheimer's disease; pain; depression; caregiver; behavioral health; counseling
• Additional relevant MeSH terms: Alzheimer Disease; Dementia; Depression; Aggression

Study Results

Participant Flow

Recruitment Details	2,230 persons with dementia (PWD) were contacted for telephone screening; 253 were interested and eligible for the study
Pre-assignment Detail	239 signed written informed consent and 233 completed baseline assessments (5 were lost and 1 withdrew after signing consent); 4 were excluded at baseline due to the presence of aggression in the 3 months prior to baseline based on Cohen-Mansfield Agitation Inventory (CMAI); 1 participant withdrew prior to randomization; 228 participants were randomly assigned to a study arm (114 in each group).

Arm/Group Title	Aggression Prevention Training (APT)	Enhanced Usual Primary Care (EU-PC)
Arm/Group Description	APT will use active learning tools, including didactics, role-playing, and multimedia [eg, books and digital video disc (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. Aggression Prevention Training (APT)	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. Enhanced Usual Primary Care (EU-PC)
Period Title: Overall Study
STARTED	114	114
Month 3	104	109
Month 6	102	107
Month 12	99	100
COMPLETED	78	78
NOT COMPLETED	36	36

Baseline Characteristics

Arm/Group Title	Aggression Prevention Training (APT)	Enhanced Usual Primary Care (EU-PC)	Total
Arm/Group Description	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. Aggression Prevention Training (APT)	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. Enhanced Usual Primary Care (EU-PC)	Total of all reporting groups
Overall Participants	114	114	228
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	77.98 (9.16)	78.31 (8.75)	78.15 (8.97)
Sex: Female, Male (Count of Participants)
Female	48 42.1%	49 43%	97 42.5%
Male	66 57.9%	65 57%	131 57.5%
Race/Ethnicity, Customized (Count of Participants)
Non-Hispanic White	78 68.4%	75 65.8%	153 67.1%
Black	24 21.1%	24 21.1%	48 21.1%
Hispanic	9 7.9%	12 10.5%	21 9.2%
Individual with Dementia-reported Overall Pain (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	1.38 (1.12)	1.13 (1.24)	1.25 (1.18)
Caregiver-reported Overall Pain (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	1.44 (1.11)	1.16 (1.12)	1.30 (1.12)
Geriatric Depression Scale (GDS) (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	11.88 (6.25)	11.10 (6.48)	11.49 (6.36)
Mutuality Scale (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	2.93 (0.79)	3.05 (0.76)	2.99 (0.78)
Zarit Burden Inventory (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	27.77 (15.03)	27.00 (13.29)	27.39 (15.13)
Positive Aspects of Caregiving (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	24.18 (9.00)	23.88 (9.54)	24.03 (9.25)
Revised Memory and Behavior Checklist (RMBC) - Total Frequency (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	8.13 (3.79)	7.56 (3.43)	7.85 (3.62)

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Aggression as Per the Cohen Mansfield Agitation Inventory, Aggression Subscale
Description	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.
Time Frame	one year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Aggression Prevention Training (APT)	Enhanced Usual Primary Care (EU-PC)
Arm/Group Description	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. Aggression Prevention Training (APT)	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. Enhanced Usual Primary Care (EU-PC)
Measure Participants	114	114
Count of Participants [Participants]	29 25.4%	23 20.2%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Aggression Prevention Training (APT), Enhanced Usual Primary Care (EU-PC)
	Comments	Sample-size calculations were performed, based on the ability to detect a small-to-moderate difference (Cohen's h = 0.4) in rate of aggression onset over a 1-year period between APT and EU-PC, assuming 80% power and a type I error rate of 5%. Given an anticipated rate of aggression onset over 1 year of 37% for EU-PC, an ES of h = 0.4 allows detection of aggression onset in APT as high as 19%. Given this effect size and up to 10% attrition, our goal was to include 220 total participants.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.29
	Comments	For participants who dropped out, their time until study attrition was used as the exposure period; and they were carried forward as part of the overall incidence count.
	Method	Regression, Cox
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	1.34
	Confidence Interval	(2-Sided) 95%; 0.78 to 2.32
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Aggression Prevention Training (APT), Enhanced Usual Primary Care (EU-PC)
	Comments
	Type of Statistical Test	Equivalence
	Comments	Examination of whether the presence of aggression is equivalent between APT and EU-PC
Statistical Test of Hypothesis	p-Value	0.27
	Comments	Association between presence of aggression and condition (APT vs EU-PC).
	Method	Chi-squared
	Comments	X2(1) = 1.21
Method of Estimation	Estimation Parameter	Difference in frequencies
	Estimated Value	1.21
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Caregiver Burden--Zarit Burden Interview
Description	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.
Time Frame	one year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Aggression Prevention Training (APT)	Enhanced Usual Primary Care (EU-PC)
Arm/Group Description	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. Aggression Prevention Training (APT)	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. Enhanced Usual Primary Care (EU-PC)
Measure Participants	114	114
Mean (Standard Deviation) [units on a scale]	26.12 (14.72)	28.37 (16.27)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Aggression Prevention Training (APT), Enhanced Usual Primary Care (EU-PC)
	Comments	Differences between APT and EU-PC in change over time (baseline, and 3, 6 and 12 months) for our secondary outcomes were evaluated using individual linear growth curve models (SAS Proc Mixed, SAS Institute, Inc., Cary, NC) with an autoregressive covariance structure type. The main interest was the interaction between group (APT vs EU-PC) and time.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.19
	Comments	P value for interaction between treatment arm and time
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	F-statistic
	Estimated Value	1.59
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments	Interaction between time and treatment arm: Numerator df = 3, denominator df = 510

3. Secondary Outcome

Title	Positive Caregiving Attributes--Positive Aspects of Caregiving Scale
Description	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.
Time Frame	one year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Aggression Prevention Training (APT)	Enhanced Usual Primary Care (EU-PC)
Arm/Group Description	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. Aggression Prevention Training (APT)	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. Enhanced Usual Primary Care (EU-PC)
Measure Participants	114	114
Mean (Standard Deviation) [units on a scale]	25.87 (8.46)	25.00 (9.53)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Aggression Prevention Training (APT), Enhanced Usual Primary Care (EU-PC)
	Comments	Differences between APT and EU-PC in change over time (baseline, and 3, 6 and 12 months) for our secondary outcomes were evaluated using individual linear growth curve models (SAS Proc Mixed, SAS Institute, Inc., Cary, NC) with an autoregressive covariance structure type. The main interest was the interaction between group (APT vs EU-PC) and time.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.06
	Comments	P value for interaction between treatment arm and time
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	F-statistic
	Estimated Value	2.43
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments	Interaction between time and treatment arm: Numerator df = 3, denominator df = 510

4. Secondary Outcome

Title	Behavior Problems--Revised Memory and Behavior Checklist
Description	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.
Time Frame	one year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Aggression Prevention Training (APT)	Enhanced Usual Primary Care (EU-PC)
Arm/Group Description	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. Aggression Prevention Training (APT)	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. Enhanced Usual Primary Care (EU-PC)
Measure Participants	114	114
Mean (Standard Deviation) [units on a scale]	7.86 (4.37)	7.51 (4.08)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Aggression Prevention Training (APT), Enhanced Usual Primary Care (EU-PC)
	Comments	Differences between APT and EU-PC in change over time (baseline, and 3, 6 and 12 months) for our secondary outcomes were evaluated using individual linear growth curve models (SAS Proc Mixed, SAS Institute, Inc., Cary, NC) with an autoregressive covariance structure type. The main interest was the interaction between group (APT vs EU-PC) and time.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.80
	Comments	P value for interaction between treatment arm and time
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	F-statistic
	Estimated Value	0.33
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments	Interaction between time and treatment arm: Numerator df = 3, denominator df = 510

5. Secondary Outcome

Title	Pain--Philadelphia Geriatric Pain Intensity Scale (Overall Pain as Reported by the PWD)
Description	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.
Time Frame	one year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Aggression Prevention Training (APT)	Enhanced Usual Primary Care (EU-PC)
Arm/Group Description	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. Aggression Prevention Training (APT)	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. Enhanced Usual Primary Care (EU-PC)
Measure Participants	114	114
Mean (Standard Deviation) [units on a scale]	1.19 (1.14)	1.12 (1.19)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Aggression Prevention Training (APT), Enhanced Usual Primary Care (EU-PC)
	Comments	Differences between APT and EU-PC in change over time (baseline, and 3, 6 and 12 months) for our secondary outcomes were evaluated using individual linear growth curve models (SAS Proc Mixed, SAS Institute, Inc., Cary, NC) with an autoregressive covariance structure type. The main interest was the interaction between group (APT vs EU-PC) and time.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.89
	Comments	P value for interaction between treatment arm and time
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	F-statistic
	Estimated Value	0.21
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments	Interaction between time and treatment arm: Numerator df = 3, denominator df = 510

6. Secondary Outcome

Title	Depression--Geriatric Depression Screen (GDS), Caregiver Version
Description	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.
Time Frame	one year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Aggression Prevention Training (APT)	Enhanced Usual Primary Care (EU-PC)
Arm/Group Description	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. Aggression Prevention Training (APT)	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. Enhanced Usual Primary Care (EU-PC)
Measure Participants	114	114
Mean (Standard Deviation) [units on a scale]	12.06 (6.98)	11.43 (7.42)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Aggression Prevention Training (APT), Enhanced Usual Primary Care (EU-PC)
	Comments	Differences between APT and EU-PC in change over time (baseline, and 3, 6 and 12 months) for our secondary outcomes were evaluated using individual linear growth curve models (SAS Proc Mixed, SAS Institute, Inc., Cary, NC) with an autoregressive covariance structure type. The main interest was the interaction between group (APT vs EU-PC) and time.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.22
	Comments	P value for interaction between treatment arm and time
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	F-statistic
	Estimated Value	1.48
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments	Interaction between time and treatment arm: Numerator df = 3, denominator df = 510

7. Secondary Outcome

Title	Caregiver-Patient Relationship Quality--Mutuality Scale
Description	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.
Time Frame	one year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Aggression Prevention Training (APT)	Enhanced Usual Primary Care (EU-PC)
Arm/Group Description	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. Aggression Prevention Training (APT)	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. Enhanced Usual Primary Care (EU-PC)
Measure Participants	114	114
Mean (Standard Deviation) [units on a scale]	2.91 (0.85)	2.99 (0.78)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Aggression Prevention Training (APT), Enhanced Usual Primary Care (EU-PC)
	Comments	Differences between APT and EU-PC in change over time (baseline, and 3, 6 and 12 months) for our secondary outcomes were evaluated using individual linear growth curve models (SAS Proc Mixed, SAS Institute, Inc., Cary, NC) with an autoregressive covariance structure type. The main interest was the interaction between group (APT vs EU-PC) and time.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.77
	Comments	P value for interaction between treatment arm and time
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	F-statistic
	Estimated Value	0.38
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments	Interaction between time and treatment arm: Numerator df = 3, denominator df = 510

8. Secondary Outcome

Title	Pain--Philadelphia Geriatric Pain Intensity Scale (Overall Pain as Reported by the Caregiver)
Description	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.
Time Frame	one year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Aggression Prevention Training (APT)	Enhanced Usual Primary Care (EU-PC)
Arm/Group Description	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. Aggression Prevention Training (APT)	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. Enhanced Usual Primary Care (EU-PC)
Measure Participants	114	114
Mean (Standard Deviation) [units on a scale]	1.48 (1.07)	1.20 (1.10)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Aggression Prevention Training (APT), Enhanced Usual Primary Care (EU-PC)
	Comments	Differences between APT and EU-PC in change over time (baseline, and 3, 6 and 12 months) for our secondary outcomes were evaluated using individual linear growth curve models (SAS Proc Mixed, SAS Institute, Inc., Cary, NC) with an autoregressive covariance structure type. The main interest was the interaction between group (APT vs EU-PC) and time.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.64
	Comments	P value for interaction between treatment arm and time
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	F-statistic
	Estimated Value	0.56
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments	Interaction between time and treatment arm: Numerator df = 3, denominator df = 510

Adverse Events

Time Frame	Serious Adverse Events data were collected through the end of the study (Month 12). All events were considered unrelated to the study.
Adverse Event Reporting Description	This is a minimal risk behavioral intervention. Non-serious adverse events were not collected.
Arm/Group Title	Aggression Prevention Training (APT)		Enhanced Usual Primary Care (EU-PC)
Arm/Group Description	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. Aggression Prevention Training (APT)		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. Enhanced Usual Primary Care (EU-PC)
All Cause Mortality
	Aggression Prevention Training (APT)		Enhanced Usual Primary Care (EU-PC)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	7/114 (6.1%)		7/114 (6.1%)
Serious Adverse Events
	Aggression Prevention Training (APT)		Enhanced Usual Primary Care (EU-PC)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	15/114 (13.2%)		18/114 (15.8%)
Blood and lymphatic system disorders
Hospitalization	1/114 (0.9%)	1	0/114 (0%)	0
Cardiac disorders
Hospitalization	1/114 (0.9%)	1	0/114 (0%)	0
Death	1/114 (0.9%)	1	0/114 (0%)	0
Endocrine disorders
Hospitalization	1/114 (0.9%)	1	0/114 (0%)	0
Gastrointestinal disorders
Hospitalization	1/114 (0.9%)	1	0/114 (0%)	0
General disorders
Hospitalization	0/114 (0%)	0	3/114 (2.6%)	3
Death	2/114 (1.8%)	2	5/114 (4.4%)	5
Injury, poisoning and procedural complications
Hospitalization	0/114 (0%)	0	2/114 (1.8%)	2
Death	0/114 (0%)	0	1/114 (0.9%)	1
Musculoskeletal and connective tissue disorders
Hospitalization	0/114 (0%)	0	2/114 (1.8%)	2
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Death	1/114 (0.9%)	1	0/114 (0%)	0
Nervous system disorders
Hospitalization	1/114 (0.9%)	1	0/114 (0%)	0
Death	1/114 (0.9%)	1	1/114 (0.9%)	1
Renal and urinary disorders
Hospitalization	2/114 (1.8%)	2	0/114 (0%)	0
Death	1/114 (0.9%)	1	0/114 (0%)	0
Respiratory, thoracic and mediastinal disorders
Hospitalization	1/114 (0.9%)	1	0/114 (0%)	0
Death	1/114 (0.9%)	1	0/114 (0%)	0
Skin and subcutaneous tissue disorders
Hospitalization	0/114 (0%)	0	1/114 (0.9%)	1
Surgical and medical procedures
Hospitalization	0/114 (0%)	0	3/114 (2.6%)	3
Other (Not Including Serious) Adverse Events
	Aggression Prevention Training (APT)		Enhanced Usual Primary Care (EU-PC)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.