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

NCT02380703 | Completed Results DMC

• 2 other identifiers: H-33720R01NR014657-01A1
• Study Type: interventional
• Target: 239
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Aggression as Per the Cohen Mansfield Agitation Inventory, Aggression Subscale

  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.

  one year

Secondary Outcomes (7)

• Caregiver Burden--Zarit Burden Interview

  one year

• Positive Caregiving Attributes--Positive Aspects of Caregiving Scale

  one year

• Behavior Problems--Revised Memory and Behavior Checklist

  one year

• Pain--Philadelphia Geriatric Pain Intensity Scale (Overall Pain as Reported by the PWD)

  one year

• Depression--Geriatric Depression Screen (GDS), Caregiver Version

  one year

Study Arms (2)

Aggression Prevention Training (APT)

EXPERIMENTAL

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)

Enhanced Usual Primary Care (EU-PC)

PLACEBO COMPARATOR

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)

Interventions

Aggression Prevention Training (APT) BEHAVIORAL

Aggression Prevention Training (APT)

Enhanced Usual Primary Care (EU-PC) OTHER

Enhanced Usual Primary Care (EU-PC)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

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

Related Publications (1)

• 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.

  PMID: 33530695 DERIVED

MeSH Terms

Conditions

Dementia; Pain; Alzheimer Disease; Aggression; Depression

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Tauopathies; Neurodegenerative Diseases; Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior; Social Behavior

Results Point of Contact

• Title: Mark Kunik, MD, MPH, Primary Investigator
• Organization: Baylor College of Medicine

mkunik@bcm.edu

713-794-8639

Study Officials

• Mark E. Kunik, M.D., Ph.D.

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., M.P.H., Professor

Study Record Dates

• First Submitted: March 1, 2015
• First Posted: March 5, 2015
• Study Start: February 5, 2015
• Primary Completion: October 23, 2018
• Study Completion: October 23, 2018
• Last Updated: December 11, 2020
• Results First Posted: December 11, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share