Study Stopped
PI relocated to UNCP; Study is not being transferred
Reminiscence, Anxiety and Early Alzheimer's Disease
1 other identifier
interventional
N/A
1 country
1
Brief Summary
This study seeks to establish the acceptability and evaluate the limited efficacy of Simple Reminiscence (SR), a home-delivered non-pharmacological intervention designed to relieve stress, improve affect, and prevent or quell disruptive or maladaptive behaviors in community-residing individuals diagnosed with early Alzheimer's disease (EAD). Unmanaged episodes of anxiety can be antecedents of maladaptive behaviors, including agitation, anger, and sometimes even violence. SR is a dyadic strategy; both the person with EAD and the caregiver engaged the patient's memory to interrupt a current episode of anxiety.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jan 2015
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 15, 2014
CompletedFirst Posted
Study publicly available on registry
December 18, 2014
CompletedStudy Start
First participant enrolled
January 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2017
CompletedJune 26, 2015
June 1, 2015
1.9 years
December 15, 2014
June 25, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Acceptability of SR and AC
Taped interview with the dyad will occur asking how acceptable the format, duration, and frequency of the program
Week 20
Secondary Outcomes (10)
Number of times AC was used
Week 20
Number of times SR was used
Week 20
Change in Beck Depression Inventory-II (BDI-II) scale
Baseline, week 20
Change in State-Trait Anxiety Inventory (STAI) scale
Baseline, week 20
Change in Katz Instrumental Activities of Daily Living (IADL) scale
Baseline, week 20
- +5 more secondary outcomes
Study Arms (2)
Simple Reminiscence (SR) caregiver
EXPERIMENTALSubjects are caregivers for a persons with EAD and will be administered SR intervention and an attention control treatment four times
Simple Reminiscence (SR) EAD
EXPERIMENTALSubjects are persons with EAD and will be administered SR intervention and an attention control treatment four times
Interventions
SR is a 30-minute psychoeducational activity administered by a trained RA at 4 home visits (week 2, week 3, week 7, and week 19). SR has a didactic component using the SR manual that the couple retains, viewing one of the brief video-vignettes illustrating the application of reminiscence techniques (a different video-vignette will be viewed at each visit), and facilitation of caregiver practice in applying the techniques, using a recent example of anxiety-linked experience of the person with EAD.
AC is a 30-minute in which the person with EAD, the caregiver and the RA review and discuss the day's newspaper headlines. The RA will use communication techniques specifically designed to keep the conversation present focused at 4 home visits (week 2, week 3, week 7, and week 19).
Eligibility Criteria
You may qualify if:
- Live in the community
- Reside with a primary caregiver who must be willing to participate in all study activities (the primary caregiver must have a familial or marital relationship with the person with EAD of sufficient length to support reminiscence activity \[i.e., an adult child, a long-term spouse or committed partner\])
- Have received a diagnosis of Early Alzheimer's Disease from a primary care provider
- Achieve a score on the mini-mental state examination (MMSE) between 19 and 25
You may not qualify if:
- Unable to give consent
- MMSE score lower than 19 or greater than 25.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Emory Universitylead
Study Sites (1)
Emory Alzheimer's Disease Research Center
Atlanta, Georgia, 30329, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
William Puentes, PhD RN FAAN
Emory University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Professor
Study Record Dates
First Submitted
December 15, 2014
First Posted
December 18, 2014
Study Start
January 1, 2015
Primary Completion
December 1, 2016
Study Completion
June 1, 2017
Last Updated
June 26, 2015
Record last verified: 2015-06