NCT04024670

Brief Summary

nuts and bolts

Trial Health

87
On Track

Trial Health Score

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

Enrollment
148

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2019

Longer than P75 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

Study Start

First participant enrolled

January 1, 2019

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 25, 2019

Completed
3 months until next milestone

First Posted

Study publicly available on registry

July 18, 2019

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2023

Completed
Last Updated

July 10, 2024

Status Verified

July 1, 2024

Enrollment Period

4.6 years

First QC Date

April 25, 2019

Last Update Submit

July 9, 2024

Conditions

Keywords

arts in medicinesewing

Outcome Measures

Primary Outcomes (5)

  • Evaluate patient experience during the course of intervention using name of survey

    define survey - evaluate experiences, range of survey - explain likert scale 0-10 with 0 being x (allows patient to rate how much they disagree or agree with a statement), 0 being the worst outcome and 10 being the best

    Baseline at admissions

  • Evaluate patient experience during the course of intervention using name of survey

    define survey - evaluate experiences, range of survey - explain likert scale 0-10 with 0 being x (allows patient to rate how much they disagree or agree with a statement), 0 being the worst outcome and 10 being the best

    Baseline - end of week 1

  • Evaluate patient experience during the course of intervention using name of survey

    define survey - evaluate experiences, range of survey - explain likert scale 0-10 with 0 being x (allows patient to rate how much they disagree or agree with a statement), 0 being the worst outcome and 10 being the best

    week 1- week 2

  • Evaluate patient experience during the course of intervention using name of survey

    define survey - evaluate experiences, range of survey - explain likert scale 0-10 with 0 being x (allows patient to rate how much they disagree or agree with a statement), 0 being the worst outcome and 10 being the best

    week 2 - week 3

  • Evaluate patient experience during the course of intervention using name of survey

    define survey - evaluate experiences, range of survey - explain likert scale 0-10 with 0 being x (allows patient to rate how much they disagree or agree with a statement), 0 being the worst outcome and 10 being the best

    week 3 - weekly up to 10 weeks

Study Arms (4)

Patients on a high-risk obstetrics unit with an anticipated stay of two or more weeks

ACTIVE COMPARATOR

patients in this group will receive twice weekly sewing and embroidery interactions with a professional artist in residence.

Other: Arts Intervention

Patients on a bone marrow transplant unit with an anticipated stay of two or more weeks

ACTIVE COMPARATOR

patients in this group will receive twice weekly visits with a professional storyteller.

Other: Arts Intervention

HRO Standard of Care

NO INTERVENTION

SOC

BMT Standard of Care

NO INTERVENTION

SOC

Interventions

If selected for the arts activity, an artist in residence will visit you 3 times a week for a total of 3 weeks during your hospital stay. Two visits will focus on the arts activity and one visit will be the administration of the questionnaire. Each visit will be approximately 25 minutes at a time.

Patients on a bone marrow transplant unit with an anticipated stay of two or more weeksPatients on a high-risk obstetrics unit with an anticipated stay of two or more weeks

Eligibility Criteria

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

You may qualify if:

  • Inpatient on either Bone Marrow Transplant ICU or High Risk Obstetrics Unit
  • Estimated length of stay 2 or more weeks
  • Age \>18
  • Patients who will potentially benefit from the AIM experience
  • For the High Risk Obstetrics Unit group (hand-sewing), patients should be physically able to participate in hand-sewing activity.
  • For the Bone Marrow Transplant IUC group (story-telling/poetry), patients should be physically able to participate in story-telling/poetry activity.

You may not qualify if:

  • Patient too ill
  • Complex medical condition that requires therapies which would not allow time for participation
  • Declined to participate
  • Age \<18

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

Study Officials

  • Kimberly P Kirklin, MA

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 25, 2019

First Posted

July 18, 2019

Study Start

January 1, 2019

Primary Completion

August 1, 2023

Study Completion

August 1, 2023

Last Updated

July 10, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

At this time we do not have IRB approval to share IPD. We may change this in the future.

Locations