Reminiscence, Anxiety and Early Alzheimer's Disease

Alzheimer's Disease Clinical Trial

Official title:

Reminiscence, Anxiety and Early Alzheimer's Disease

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02319681
• Other study ID #: IRB00075912
• Status: Withdrawn
• Phase: N/A
• First received: December 15, 2014
• Last updated: June 25, 2015
• Start date: January 2015
• Est. completion date: June 2017

Study information

• Verified date: June 2015
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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:

1. A didactic component using the SR manual that the couple retains (15 minutes);

2. 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

3. 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Behavioral:
• Simple Reminiscence (SR)
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.
• Attention Control (AC)
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).

Locations

Country	Name	City	State
United States	Emory Alzheimer's Disease Research Center	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Emory University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Number of times AC was used	Taped interview with the dyad will occur asking how frequently AC was used	Week 20	No
Secondary	Number of times SR was used	Taped interview with the dyad will occur asking how frequently SR was used	Week 20	No
Secondary	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.	Baseline, week 20	No
Secondary	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.	Baseline, week 20	No
Secondary	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.	Baseline, week 20	No
Secondary	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).	Baseline, week 20	No
Secondary	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.	Baseline, week 20	No
Secondary	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.	Baseline, week 20	No
Secondary	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.	Week 20	No
Secondary	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).	Baseline, Week 20	No