Reminiscence, Anxiety and Early Alzheimer's Disease
Primary Purpose
Alzheimer's Disease
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Simple Reminiscence (SR)
Attention Control (AC)
Sponsored by
About this trial
This is an interventional supportive care trial for Alzheimer's Disease focused on measuring Caregivers, Anxiety, Depression
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- Unable to give consent
- MMSE score lower than 19 or greater than 25.
Sites / Locations
- Emory Alzheimer's Disease Research Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Simple Reminiscence (SR) caregiver
Simple Reminiscence (SR) EAD
Arm Description
Subjects are caregivers for a persons with EAD and will be administered SR intervention and an attention control treatment four times
Subjects are persons with EAD and will be administered SR intervention and an attention control treatment four times
Outcomes
Primary Outcome Measures
Acceptability of SR and AC
Taped interview with the dyad will occur asking how acceptable the format, duration, and frequency of the program
Secondary Outcome Measures
Number of times AC was used
Taped interview with the dyad will occur asking how frequently AC was used
Number of times SR was used
Taped interview with the dyad will occur asking how frequently SR was used
Change in Beck Depression Inventory-II (BDI-II) scale
BDI-II is a 21-item, self-administered tool used to measure depressive symptoms. Scores range from 0 - 63, with higher scores indicating more severe depressive symptoms.
Change in State-Trait Anxiety Inventory (STAI) scale
STAI is a 20-item tool that measures current anxiety symptoms with scores that range from 20 to 80, with higher scores indicating greater levels of anxiety.
Change in Katz Instrumental Activities of Daily Living (IADL) scale
IADL is a six-item tool assessing the degree of independence vs. dependence in basic activities of daily living, with higher scores indicating greater levels of daily functioning.
Change in Well-Being Picture Scale (WBPS) scale
WBPS is a 10-item non-language based pictorial scale that measures general well-being. Individuals are asked to mark the point along each scale to indicate which image they feel most like (drawings depicting a sense of high or low well-being are arranged at opposite ends of a scale).
Change in Short Psychological Well-Being Scale (SPWBS) scale
SPWBS is a 84-item self-report, Likert-type inventory that measures well-being across six dimensions: Self-Acceptance, Positive Relations With Others, Autonomy, Environmental Mastery, Purpose in Life, and Personal Growth. A higher score indicated a greater sense of well-being.
Change in Revised Memory and Behavior Problems Checklist (RMBPC) scale
RMBPC is a 24-item Likert-type caregiver-report measure of observable behavioral problems in dementia.
Caregiver's mastery of SR intervention technique
Simple Reminiscence Intervention Mastery Assessment (SRIMA) evaluation rubric to be used to determine the person with EAD's and their caregiver's mastery of the SR Intervention techniques.
Change in levels of cortisol
Both members of the dyad will collect saliva to evaluate diurnal cortisol secretion by standard enzyme-linked immunoabsorbant assay ( ELISA).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02319681
Brief Title
Reminiscence, Anxiety and Early Alzheimer's Disease
Official Title
Reminiscence, Anxiety and Early Alzheimer's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Withdrawn
Why Stopped
PI relocated to UNCP; Study is not being transferred
Study Start Date
January 2015 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
June 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
Through the intervention, family caregivers are trained to collaborate with and guide patients to access positive memories as a way to manage or move past the anxiety that plagues individuals with EAD - often arising when confronted by common complex tasks they previously were able to perform.
During the project's first six months (phase 1), the investigators will develop a series of 4 video-vignettes illustrating dyads (including one member with EAD) managing a variety of anxiety provoking scenarios associated with EAD (e.g., trouble reconciling a checkbook) through the use of SR.
During the second phase of the project, a research assistant will administer SR at four home visits. The SR intervention has three components:
A didactic component using the SR manual that the couple retains (15 minutes);
Viewing one of the brief video-vignettes illustrating the application of reminiscence techniques (5 minutes; 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 (10 minutes). The caregiver is encouraged to learn and practice the techniques in order to cue and coach the person with EAD in their use.
The attention control treatment, a Social Visit, is a 30-minute activity in which the person with EAD, the caregiver and the research assistant (RA) review and discuss the day's newspaper headlines. The RA will use communication techniques specifically designed to keep the conversation present focused.
Both members of the dyad will collect saliva to evaluate diurnal cortisol secretion.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease
Keywords
Caregivers, Anxiety, Depression
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Simple Reminiscence (SR) caregiver
Arm Type
Experimental
Arm Description
Subjects are caregivers for a persons with EAD and will be administered SR intervention and an attention control treatment four times
Arm Title
Simple Reminiscence (SR) EAD
Arm Type
Experimental
Arm Description
Subjects are persons with EAD and will be administered SR intervention and an attention control treatment four times
Intervention Type
Behavioral
Intervention Name(s)
Simple Reminiscence (SR)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Attention Control (AC)
Intervention Description
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).
Primary Outcome Measure Information:
Title
Acceptability of SR and AC
Description
Taped interview with the dyad will occur asking how acceptable the format, duration, and frequency of the program
Time Frame
Week 20
Secondary Outcome Measure Information:
Title
Number of times AC was used
Description
Taped interview with the dyad will occur asking how frequently AC was used
Time Frame
Week 20
Title
Number of times SR was used
Description
Taped interview with the dyad will occur asking how frequently SR was used
Time Frame
Week 20
Title
Change in Beck Depression Inventory-II (BDI-II) scale
Description
BDI-II is a 21-item, self-administered tool used to measure depressive symptoms. Scores range from 0 - 63, with higher scores indicating more severe depressive symptoms.
Time Frame
Baseline, week 20
Title
Change in State-Trait Anxiety Inventory (STAI) scale
Description
STAI is a 20-item tool that measures current anxiety symptoms with scores that range from 20 to 80, with higher scores indicating greater levels of anxiety.
Time Frame
Baseline, week 20
Title
Change in Katz Instrumental Activities of Daily Living (IADL) scale
Description
IADL is a six-item tool assessing the degree of independence vs. dependence in basic activities of daily living, with higher scores indicating greater levels of daily functioning.
Time Frame
Baseline, week 20
Title
Change in Well-Being Picture Scale (WBPS) scale
Description
WBPS is a 10-item non-language based pictorial scale that measures general well-being. Individuals are asked to mark the point along each scale to indicate which image they feel most like (drawings depicting a sense of high or low well-being are arranged at opposite ends of a scale).
Time Frame
Baseline, week 20
Title
Change in Short Psychological Well-Being Scale (SPWBS) scale
Description
SPWBS is a 84-item self-report, Likert-type inventory that measures well-being across six dimensions: Self-Acceptance, Positive Relations With Others, Autonomy, Environmental Mastery, Purpose in Life, and Personal Growth. A higher score indicated a greater sense of well-being.
Time Frame
Baseline, week 20
Title
Change in Revised Memory and Behavior Problems Checklist (RMBPC) scale
Description
RMBPC is a 24-item Likert-type caregiver-report measure of observable behavioral problems in dementia.
Time Frame
Baseline, week 20
Title
Caregiver's mastery of SR intervention technique
Description
Simple Reminiscence Intervention Mastery Assessment (SRIMA) evaluation rubric to be used to determine the person with EAD's and their caregiver's mastery of the SR Intervention techniques.
Time Frame
Week 20
Title
Change in levels of cortisol
Description
Both members of the dyad will collect saliva to evaluate diurnal cortisol secretion by standard enzyme-linked immunoabsorbant assay ( ELISA).
Time Frame
Baseline, Week 20
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
Unable to give consent
MMSE score lower than 19 or greater than 25.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William Puentes, PhD RN FAAN
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emory Alzheimer's Disease Research Center
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30329
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Reminiscence, Anxiety and Early Alzheimer's Disease
We'll reach out to this number within 24 hrs