Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02380703
Recruitment Status : Completed
First Posted : March 5, 2015
Results First Posted : December 11, 2020
Last Update Posted : December 11, 2020
Sponsor:
Collaborator:
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
Mark Kunik, 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.

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) Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
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 : February 5, 2015
Actual Primary Completion Date : October 23, 2018
Actual Study Completion Date : October 23, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers Dementia

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)



Primary Outcome Measures :
  1. Number of Participants With Aggression as Per the Cohen Mansfield Agitation Inventory, Aggression Subscale [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02380703


Sponsors and Collaborators
Baylor College of Medicine
National Institute of Nursing Research (NINR)
Investigators
Layout table for investigator information
Principal Investigator: Mark E. Kunik, M.D., Ph.D. Baylor College of Medicine
  Study Documents (Full-Text)

Documents provided by Mark Kunik, Baylor College of Medicine:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
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 ( U.S. NIH Grant/Contract )
First Posted: March 5, 2015    Key Record Dates
Results First Posted: December 11, 2020
Last Update Posted: December 11, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description:

The information generated in this proposal aims to prevent the development of aggression in persons with dementia. Clinician and participant manuals are developed for the intervention and will be widely shared through abstracts, presentation, publication and personal communication if the intervention is efficacious. In addition, if the intervention is found to be evidence-based, we will pursue placement on the websites of:

1) Substance Abuse and Mental Health Services Administration (SAMHSA) National Registry for Evidence-based Programs and 2) Rosalynn Carter Institute for Caregiving (RCI) Caregiver Intervention Database. Information about the study will also be available to interested investigators through NIH CRISP, and the Baylor College of Medicine Section of Health Services Research website. Requests to use the information will be considered on a case-by-case basis, following written request to the principal investigator.

Keywords provided by Mark Kunik, Baylor College of Medicine:
aggression
dementia
Alzheimer's disease
pain
depression
caregiver
behavioral health
counseling
Additional relevant MeSH terms:
Layout table for MeSH terms
Alzheimer Disease
Dementia
Depression
Aggression
Behavioral Symptoms
Mental Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders