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Alzheimer's DiseaseNCT02319681

Reminiscence, Anxiety and Early Alzheimer's Disease

A study testing Simple Reminiscence (SR) in people with Alzheimer's Disease, run by Emory University at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Alzheimer's Disease
What is being tested?
Simple Reminiscence (SR)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
Jan 2015to Jun 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Unable to give consent
  • MMSE score lower than 19 or greater than 25.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Emory Alzheimer's Disease Research Center

    Atlanta, Georgia, 30329

Other trials in United States

About this study

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.

Read the 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.

Being tested
Simple Reminiscence (SR), Attention Control (AC)
Keywords
Caregivers, Anxiety, Depression
Medical subject headings
Alzheimer Disease, Anxiety Disorders, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Simple Reminiscence (SR)Behavioural

    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)Behavioural

    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).

Study groups in NCT02319681
Study groupRoleWhat they receive
Simple Reminiscence (SR) caregiverExperimentalSubjects are caregivers for a persons with EAD and will be administered SR intervention and an attention control treatment four times
Receives: Behavioral: Simple Reminiscence (SR); Behavioral: Attention Control (AC)
Simple Reminiscence (SR) EADExperimentalSubjects are persons with EAD and will be administered SR intervention and an attention control treatment four times
Receives: Behavioral: Simple Reminiscence (SR); Behavioral: Attention Control (AC)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Acceptability of SR and AC

    Taped interview with the dyad will occur asking how acceptable the format, duration, and frequency of the program

    Measured: Week 20

Secondary outcomes (10)

  1. Number of times AC was used

    Taped interview with the dyad will occur asking how frequently AC was used

    Measured: Week 20

  2. Number of times SR was used

    Taped interview with the dyad will occur asking how frequently SR was used

    Measured: Week 20

  3. 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.

    Measured: Baseline, week 20

  4. 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.

    Measured: Baseline, week 20

  5. 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.

    Measured: Baseline, week 20

  6. 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).

    Measured: Baseline, week 20

  7. 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.

    Measured: Baseline, week 20

  8. 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.

    Measured: Baseline, week 20

  9. 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.

    Measured: Week 20

  10. 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).

    Measured: Baseline, Week 20

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Dec 2014 (estimated)
  2. Study startJan 2015
  3. Primary completionDec 2016 (estimated)
  4. Study completionJun 2017 (estimated)

Why it stopped: PI relocated to UNCP; Study is not being transferred

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02319681
Sponsor's protocol ID
IRB00075912
Status last verified
Jun 2015
First submitted
15 Dec 2014
Last updated
26 Jun 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Simple Reminiscence (SR) in people with Alzheimer's Disease, run by Emory University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 26 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Acceptability of SR and AC (time frame: Week 20). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02319681.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2015.

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