Reminiscence, Anxiety and Early Alzheimer's Disease

NCT ID: NCT02319681

Last Updated: 2015-06-26

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2017-06-30

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:

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.

Conditions

Alzheimer's Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Simple Reminiscence (SR) caregiver

Subjects are caregivers for a persons with EAD and will be administered SR intervention and an attention control treatment four times

Group Type: EXPERIMENTAL

Simple Reminiscence (SR)

Intervention Type: BEHAVIORAL

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)

Intervention Type: BEHAVIORAL

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).

Simple Reminiscence (SR) EAD

Subjects are persons with EAD and will be administered SR intervention and an attention control treatment four times

Group Type: EXPERIMENTAL

Simple Reminiscence (SR)

Intervention Type: BEHAVIORAL

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)

Intervention Type: BEHAVIORAL

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).

Interventions

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.

Intervention Type: BEHAVIORAL

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).

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Emory University

OTHER

Sponsor Role: lead

Responsible Party

William Puentes

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

William Puentes, PhD RN FAAN

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

Emory Alzheimer's Disease Research Center

Atlanta, Georgia, United States

Countries

United States

Other Identifiers

IRB00075912

Identifier Type: -

Identifier Source: org_study_id