NCT04091893

Brief Summary

Aim 1: To conduct a formative evaluation of museum-based programming to address loneliness and social isolation. Aim 2: To develop a consensus-derived Model Museum-Based Program (MMBP) to address loneliness among individuals with chronic pain. Aim 3: To evaluate the feasibility of museum experiences to reduce loneliness and pain among isolated individuals with chronic pain. Due to safety concerns related to the covid pandemic in-person museum programming could not continue and virtual versions of the interventions were created. We will publish results on both the in-person and virtual versions of the intervention as well as a pooled analysis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
149

participants targeted

Target at P75+ for not_applicable chronic-pain

Timeline
Completed

Started Oct 2019

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 6, 2019

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 17, 2019

Completed
25 days until next milestone

Study Start

First participant enrolled

October 12, 2019

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2021

Completed
23 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 10, 2021

Completed
Last Updated

December 16, 2021

Status Verified

December 1, 2021

Enrollment Period

1.3 years

First QC Date

September 6, 2019

Last Update Submit

December 1, 2021

Conditions

Outcome Measures

Primary Outcomes (2)

  • Program satisfaction - quality: NRS

    "Please rate your satisfaction with the overall quality of your experience at the museum?" NRS - 0 (extremely dissatisfied) - 10 (extremely satisfied)

    Post-intervention (immediately)

  • Primary clinical outcome for preliminary estimate of efficacy - Social disconnection

    Social disconnection scale; 12 items; scored 1 (not at all) - 5 (very much); range 12-60

    Post-intervention (immediately)

Secondary Outcomes (15)

  • Change in pain during intervention: 1=Yes/0=No

    Post-intervention (immediately)

  • Percent change in pain during intervention

    Post-intervention (immediately)

  • Social disconnection

    Post-intervention (immediately)

  • Pain unpleasantness

    Post-intervention (immediately)

  • Pain unpleasantness

    Post-intervention (3-month follow up)

  • +10 more secondary outcomes

Study Arms (4)

Usual care/wait list

ACTIVE COMPARATOR
Behavioral: Usual care/wait list

Art Rx

EXPERIMENTAL
Behavioral: Art Rx

Artful Meditation

EXPERIMENTAL
Behavioral: Artful Meditation

Art Rx + Artful Meditation

EXPERIMENTAL
Behavioral: Art RxBehavioral: Artful Meditation

Interventions

Individuals in this group can continue with their usual care (but receive no museum-based intervention)

Usual care/wait list
Art RxBEHAVIORAL

Individuals in this group participate in a specialized tour of an art museum

Art RxArt Rx + Artful Meditation

Individuals in this group participate in a meditation and art appreciation program at an art museum

Art Rx + Artful MeditationArtful Meditation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age or older
  • English speaking
  • Chronic pain (6 months or longer)
  • Moderate pain or greater (4/10 or greater on a Numerical Rating Scale, range of 0 (no pain) - 10 (worst pain imaginable), in response to the question "Over the past week what was your average pain intensity?")
  • Moderately lonely or greater (Score of 4 or greater on 3 item Loneliness scale, range of 3 - 9)

You may not qualify if:

  • Participated in an Art Rx tour
  • Participated in an Artful Meditation program
  • Dementia or Alzheimer's disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UC Davis Ambulatory Care Center

Sacramento, California, 95817, United States

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Due to covid the in-person RCT was suspended and transitioned to virtual museum programming. Twenty-seven individuals were randomized into the in-person study and 122 individuals were randomized into the virtual study for a total of 149 enrolled individuals.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 6, 2019

First Posted

September 17, 2019

Study Start

October 12, 2019

Primary Completion

February 15, 2021

Study Completion

March 10, 2021

Last Updated

December 16, 2021

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Locations