A Randomized Controlled Trial Utilizing the Arts to Improve Health, Resilience, and Well-Being in Individuals With Chronic Health Conditions in Underserved Neighborhoods

Stopped earlyNot a drug-phase studyMS (type not specified)NCT04154579

What it found

Stopped

The trial ended early for another reason (see below).

Reason given: COVID-19 pandemic. Unable to restart as had hoped.

This trial finished 6 years ago. We found no results in the registry or in any paper that cites it.

What was tested

Treatment tested

  • HeRe We Arts

Compared with

  • HeRe We Ed

What it measured

Main measures

  • Change in Short Depression-Happiness Scale from Week 1 to Week 8

    Weeks 1 and 8

    Mood and sleep
  • Change in Short Depression-Happiness Scale from Week 8 to Week 16

    Weeks 8 and 16

    Mood and sleep
  • Change in Short Depression-Happiness Scale from Week 1 to Week 16

    Weeks 1 and 16

    Mood and sleep
  • Change in Short Warwick-Edinburgh Mental Well-Being Scale from Week 1 to Week 8

    Weeks 1 and 8

  • Change in Short Warwick-Edinburgh Mental Well-Being Scale from Week 8 to Week 16

    Weeks 8 and 16

  • Change in Short Warwick-Edinburgh Mental Well-Being Scale from Week 1 to Week 16

    Weeks 1 and 16

  • Change in Brief Resilient Coping Scale from Week 1 to Week 8

    Weeks 1 and 8

  • Change in Brief Resilient Coping Scale from Week 8 to Week 16

    Weeks 8 and 16

  • Change in Brief Resilient Coping Scale from Week 1 to Week 16

    Weeks 1 and 16

  • Change in Godin-Shephard Leisure-Time Physical Activity Questionnaire from Week 1 to Week 8

    Weeks 1 and 8

    Physical function
  • Change in Godin-Shephard Leisure-Time Physical Activity Questionnaire from Week 8 to Week 16

    Weeks 8 and 16

    Physical function
  • Change in Godin-Shephard Leisure-Time Physical Activity Questionnaire from Week 1 to Week 16

    Weeks 1 and 16

    Physical function
  • Change in PROMIS Scale v1.2 - Global Health from Week 1 to Week 8

    Weeks 1 and 8

  • Change in PROMIS Scale v1.2 - Global Health from Week 8 to Week 16

    Weeks 8 and 16

  • Change in PROMIS Scale v1.2 - Global Health from Week 1 to Week 16

    Weeks 1 and 16

  • Change in Systolic and Diastolic Blood Pressure from Week 1 to Week 8

    Weeks 1 and 8

  • Change in Systolic and Diastolic Blood Pressure from Week 8 to Week 16

    Weeks 8 and 16

  • Change in Systolic and Diastolic Blood Pressure from Week 1 to Week 16

    Weeks 1 and 16

  • Change in Heart Rate from Week 1 to Week 8

    Weeks 1 and 8

  • Change in Heart Rate from Week 8 to Week 16

    Weeks 8 and 16

  • Change in Heart Rate from Week 1 to Week 16

    Weeks 1 and 16

  • Change in Pulse Oximetry from Week 1 to Week 8

    Weeks 1 and 8

  • Change in Pulse Oximetry from Week 8 to Week 16

    Weeks 8 and 16

  • Change in Pulse Oximetry from Week 1 to Week 16

    Weeks 1 and 16

Other measures (3)

  • Change in HeRe We Arts Survey from Week 1 to Week 8

    Weeks 1 and 8

    Quality of life (reported by participants)
  • Change in HeRe We Ed Survey from Week 1 to Week 8

    Weeks 1 and 8

    Quality of life (reported by participants)
  • Weekly Post-Session Survey

    Weeks 1-8

    Quality of life (reported by participants)

Who could take part

MS (type not specified) · 18 and over

Show the full criteria

Inclusion criteria

* At least 18 years old * Diagnosed with at least one chronic health condition (as reported by the participant) * Able to participate safely in all program sessions * Proficient in English * Cognitively able to consent to participate

Exclusion criteria

* Severe visual or auditory impairment * Severe and/or uncontrolled comorbidity precluding safe participation in the program

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

This is an 8-week randomized controlled trial to help address health, resilience, and well-being. Participants are randomized into either a health education group or an arts-based health education group. Both groups will attend for 8 weeks and various study assessments will be conducted in order to measure the experience and impact of the program. Anyone 18 years and older with a chronic health condition (for example, diabetes, hypertension, congestive heart failure, chronic obstructive pulmonary disorder, asthma, weight, anxiety, depression, cardiac, arthritis, multiple sclerosis, and many more) are eligible to participate.

Papers

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History

    1. Started

      Jul 2019

    2. Main results due

      Jun 2020

    3. Finished

      Jun 2020

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