N/A
N=228
Aggression Prevention Training for Caregivers of Persons With Dementia (APT)
Dementia · Pain · Alzheimer's Disease · Aggression · Depression
Bottom Line
View on ClinicalTrials.gov: NCT02380703 ↗Enrolled (actual)
228
Serious AEs
14.5%
Results posted
Dec 2020
Primary outcome: Primary: Number of Participants With Aggression as Per the Cohen Mansfield Agitation Inventory, Aggression Subscale — 29; 23 Participants — p=0.29
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Aggression Prevention Training (APT) (Behavioral); Enhanced Usual Primary Care (EU-PC) (Other)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Baylor College of Medicine
- Primary completion
- Oct 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Aggression as Per the Cohen Mansfield Agitation Inventory, Aggression Subscale |
29; 23 | 0.29 |
| SECONDARY Caregiver Burden--Zarit Burden Interview |
26.12; 28.37 | 0.19 |
| SECONDARY Positive Caregiving Attributes--Positive Aspects of Caregiving Scale |
25.87; 25.00 | 0.06 |
| SECONDARY Behavior Problems--Revised Memory and Behavior Checklist |
7.86; 7.51 | 0.80 |
| SECONDARY Pain--Philadelphia Geriatric Pain Intensity Scale (Overall Pain as Reported by the PWD) |
1.19; 1.12 | 0.89 |
| SECONDARY Depression--Geriatric Depression Screen (GDS), Caregiver Version |
12.06; 11.43 | 0.22 |
| SECONDARY Caregiver-Patient Relationship Quality--Mutuality Scale |
2.91; 2.99 | 0.77 |
| SECONDARY Pain--Philadelphia Geriatric Pain Intensity Scale (Overall Pain as Reported by the Caregiver) |
1.48; 1.20 | 0.64 |
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT02380703). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.