Status:
COMPLETED
Project ACT: Advancing Caregiving Techniques
Lead Sponsor:
Thomas Jefferson University
Conditions:
Alzheimer's Disease
Eligibility:
All Genders
21+ years
Phase:
PHASE3
Brief Summary
The specific aims of this study are to: 1. Test the immediate effectiveness of the intervention to reduce caregiver upset with targeted disruptive behaviors (primary outcome). Hypothesis: Caregivers ...
Eligibility Criteria
Inclusion
- Caregivers are eligible for study participation if they:
- are a family member 21 years of age or older (male or female),
- live with the care recipient,
- able to participate in the interview in English
- have a telephone in their home,
- plan to live in the area for 6 months, and
- report a high level of upset with behaviors as follows. We will use the Agitated Behavior in Dementia Scale (ABID),62 which is a 16-item psychometrically valid scale of behavioral occurrences and associated caregiver upset. We chose this scale out of the six primary scales used to measure behavior given that the behaviors most closely match the intent of the intervention we plan to test. The behaviors include those listed earlier plus one additional behavior, repetitive vocalization. For each of these 17 behaviors that occur in the past week (for the purposes of screening eligibility, we will use a yes/no response format), caregivers are asked their level of upset (0 = not at all, 1 = a little, 2 = moderately, 3 = very much and 4 = extremely).
- Caregivers will be considered eligible if they obtain a total summed score of "3" or higher using the following algorithm:
- Caregivers must report at least one behavior as very ("3") or extremely ("4") upset, or
- caregivers must report three or more behaviors in which one behavior causes at least moderate ("2") level upset and one behavior causes at least a little upset.
- Thus, caregivers with only scores of "1" ( a little upset) with three or more behavioral occurrences will not be considered eligible for this study. That is, this criteria excludes caregivers with no upset or a little upset. We will also require that the care recipient: 1) has a NINCDS-ADRDA diagnosis (physician generated) of dementia or a Mini-mental State Examination (MMSE) score of \<23.
Exclusion
- A caregiver is excluded if the caregiver or care recipient:
- has a terminal illness with life expectancy \< 6 months,
- is in active treatment for cancer, or
- has had \>3 acute medical hospitalizations in the past year.
- Caregivers will also be excluded if:
- they are currently involved in another clinical trial of psychosocial or educational interventions for caregivers; or
- they are planning to place their family member in a nursing home within the next 6-months.
- Care-recipients will also be excluded if:
- they have schizophrenia or a bi-polar disorder,
- their dementia is secondary to probable head trauma,
- their MMSE score = 0 and they are considered bed-bound, defined as confinement to bed or chair for at least 22 hours a day for at least four of the previous seven days,
- a nursing home admission is planned to occur within six months or
- they are enrolled in a clinical trial of pharmacological treatment for agitation.
- These criteria exclude caregivers of ADRD patients at the severe stage of the disease process who may not benefit from the proposed intervention.
Key Trial Info
Start Date :
August 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2015
Estimated Enrollment :
272 Patients enrolled
Trial Details
Trial ID
NCT00259480
Start Date
August 1 2001
End Date
March 1 2015
Last Update
May 13 2015
Active Locations (1)
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1
Laura N. Gitlin,Ph.D
Philadelphia, Pennsylvania, United States, 19107