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

NCT ID: NCT02380703

Last Updated: 2020-12-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 239 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-05
• Study Completion Date: 2018-10-23

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.

Conditions

Dementia; Pain; Alzheimer's Disease; Aggression; Depression; Interpersonal Relations

Keywords

aggression; dementia; Alzheimer's disease; pain; depression; caregiver; behavioral health; counseling

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Aggression Prevention Training (APT)

Intervention Type: BEHAVIORAL

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.

Group Type: PLACEBO_COMPARATOR

Enhanced Usual Primary Care (EU-PC)

Intervention Type: OTHER

Interventions

Aggression Prevention Training (APT)

Intervention Type: BEHAVIORAL

Enhanced Usual Primary Care (EU-PC)

Intervention Type: OTHER

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Nursing Research (NINR)

NIH

Sponsor Role: collaborator

Baylor College of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Mark Kunik

M.D., M.P.H., Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mark E. Kunik, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Baylor College of Medicine

References

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.

Reference Type: DERIVED

PMID: 33530695 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

R01NR014657-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

H-33720

Identifier Type: -

Identifier Source: org_study_id