NCT04696549

Brief Summary

As the population ages, there is increasing interest in developing innovative approaches to promote and sustain mental and emotional well-being. Recent studies have linked engagement with the arts with supporting cognitive functioning, promoting empathy and greater sense of life purpose. The need to develop alternative approaches to sustain emotional well-being is especially acute for the nearly 6 million older Americans who suffer from Alzheimer's disease. There is a need for quality activities that can be done virtually for homebound individuals with cognitive disorders and the individuals' family care-partners. The investigators intend to institute a 3-session virtual art museum pilot program for seniors with cognitive disorders and care-partners using the Visual Thinking Strategies approach. The investigators hypothesize that participation in a virtual guided visual arts experience will enhance emotional well-being and self-esteem for both seniors with cognitive impairment and the seniors' care-partners.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 4, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 6, 2021

Completed
6 months until next milestone

Study Start

First participant enrolled

July 16, 2021

Completed
21 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 6, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2021

Completed
Last Updated

November 11, 2021

Status Verified

November 1, 2021

Enrollment Period

21 days

First QC Date

January 4, 2021

Last Update Submit

November 10, 2021

Conditions

Keywords

dementiacaregivingself-esteem

Outcome Measures

Primary Outcomes (2)

  • Change in self-esteem as assessed by the Rosenberg Self-Esteem Scale

    Impact of participation in a virtual art museum program on both older adults with cognitive disorders and their care-partners on survey measure of self-esteem. The Rosenberg Self-Esteem Scale is a 10-item self-report scale. Each item response is scored on a 4-point Likert Scale where 1 = Strongly agree and 4= Strongly disagree. Higher scores indicate higher self-esteem, and lower scores indicate lower self-esteem.

    At first session and third session, up to 3 months

  • Change in self-report mood as assessed by the Smiley Face Mood Rating Scale

    Impact of participation in a virtual art museum program on both older adults with cognitive disorders and their care-partners on self-report measure of mood. Smiley Face Mood Rating Scale- A pictorial self-report Likert scale with 5 smiley faces ranging from very unhappy (scored as 1), to very happy (scored as 5). Higher scores indicate a more positive mood and lower scores indicate a more negative mood.

    Before and immediately after each visual art session, up to 3 months

Secondary Outcomes (6)

  • to get feedback from family care-partners about their experience in participating in a virtual art museum program regarding satisfaction with a virtual program of this nature

    up to 48 hours after first visual art session

  • to get feedback from family care-partners about their experience in participating in a virtual art museum program regarding acceptability and satisfaction with a virtual program of this nature

    up to 48 hours after second visual art session

  • to get feedback from family care-partners about their experience in participating in a virtual art museum program regarding acceptability and satisfaction with a virtual program of this nature

    up to 48 hours after third visual art session

  • to get feedback from individuals with cognitive disorders about their experience in participating in a virtual art museum program regarding acceptability and satisfaction with a virtual program of this nature

    up to 48 hours after first visual art session

  • to get feedback from individuals with cognitive disorders about their experience in participating in a virtual art museum program regarding acceptability and satisfaction with a virtual program of this nature

    up to 48 hours after second visual art session

  • +1 more secondary outcomes

Study Arms (1)

virtual visual art experience for individuals with dementia and their family care-partners

EXPERIMENTAL

Individuals with dementia and their family care-partners will participate in three monthly one-hour virtual art sessions in which the facilitator uses Visual Thinking Strategies technique to facilitate participants' viewing and discussion about virtual art images.

Behavioral: Virtual visual art experience guided by Visual Thinking Strategies

Interventions

All study dyads (where study dyad consists of a participant with dementia and his/her care-partner) will participate in 3 scheduled virtual visual art sessions via Zoom. Each session will last about an hour and will include a guided discussion of pre-selected visual art using the Visual Thinking Strategies approach. It is anticipated that two pieces of art will be shown during each art session. The three sessions will be scheduled one month apart.

virtual visual art experience for individuals with dementia and their family care-partners

Eligibility Criteria

Age30 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Club Memory member with cognitive disorder and family care-partner. This will constitute a study dyad.
  • Early to moderate cognitive impairment, as evidenced by Clinical Dementia Rating scale of 0.5-2.0. The Clinical Dementia Rating scale is a clinical rating scale used for dementia staging based on 6 domains of functioning that will be performed by Andrea Nelson, Registered Nurse, and is part of normal dementia care in the Johns Hopkins Bayview Memory and Alzheimer's Treatment Center. A rating of 0=normal, 0.5= mild cognitive impairment, 1.0=mild dementia, 2.0=moderate dementia, 3.0=severe dementia.
  • Care-partner access to laptop or iPad and comfort with using Zoom technology
  • Agreement by individual with cognitive disorder and care-partner to participate in all 3 Visual Thinking visual art sessions
  • Agreement by individual with cognitive disorder and care-partner to participate in the study and complete questionnaires before and after each session

You may not qualify if:

  • Non-English speaker
  • Clinical Dementia Rating higher than 2.0 for individual with cognitive impairment
  • Inability to use a laptop or iPad for Zoom sessions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Susan W Lehmann, MD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 4, 2021

First Posted

January 6, 2021

Study Start

July 16, 2021

Primary Completion

August 6, 2021

Study Completion

November 1, 2021

Last Updated

November 11, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations