Clinical trial NCT04154579: Arts & Health Education to Improve Health, Resilience, and Well-Being
Official title: A Randomized Controlled Trial Utilizing the Arts to Improve Health, Resilience, and Well-Being in Individuals With Chronic Health Conditions in Underserved Neighborhoods
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Hypertension
Diabetes
Obesity
COPD
CHF
High Cholesterol
Asthma
Chronic Pain
Multiple Sclerosis
Depression
Anxiety
Heart Diseases
Stroke
Keywords: Chronic health conditions
Arts-based program
Health education program
Health
Resilience
Well-being
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
Collaborators: name: National Endowment for the Arts, United States
name: Cuyahoga Arts and Culture
name: The Cleveland Clinic
First posted: 2019-11-06
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a randomized controlled trial utilizing a mixed methods, pre-post intervention, and parallel group analysis.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Within the healthcare field today there is an increased concern with public health, population health, wellness, and prevention, all of which include focusing on physical health, obesity, chronic health conditions, unhealthy lifestyles, aging, and mental health issues. As healthcare professionals attempt to improve individuals' health outcomes, quality of life, well-being, coping skills, and health indicators, they also must try to promote behavior change that helps keep patients out of the hospital. These are concerns faced by individuals of all ages, genders, ethnicities, cultural backgrounds, socioeconomic statuses, and diagnoses. Therefore, it is important to find multiple means of addressing these concerns with the various populations as it is likely that no one particular method would be effective for every individual.

Programs and interventions have been created to address health, resilience, and well-being at the individual and the social level. They demonstrate the importance of providing support, encouraging behavior changes, and reinforcing objectives determined by the healthcare system. Many of these programs have focused on improving resilience and increasing participants' ability to thrive or recover from the illnesses and challenges they face.

The broad problem to be addressed by this study is to assess if arts-based programs are superior to non-arts-based health education programs at improving individuals' physical and mental health outcomes, quality of life, well-being, resilience, coping skills, stress, and health indicators while promoting behavior change and keeping them out of the hospital. Previous programs have focused on improving resilience. Individual arts interventions such as music, art, craft, choir singing, writing, theater, and movement have been utilized and in many cases found to be helpful in addressing resilience, coping, health, and well-being; however, it is not known what effect a program utilizing multiple arts-based interventions would have on adults with chronic health conditions. The primary benefit of conducting research into the effectiveness of different arts-based programs is the identification of the specific benefits of programs aimed at influencing health, resilience, and well-being in individuals with a variety of chronic health conditions.

The purpose of this randomized controlled study is to determine the outcomes of an 8-week arts-based program on the health, resilience, and well-being of individuals with chronic health conditions in an outpatient underserved community setting as compared to outcomes from individuals participating in a separate 8-week-non-arts-based health education program in the same setting. The purpose of including a variety of arts experiences is so that individuals will hopefully find at least one art form to which they can relate and will utilize in their lives to assist with their health, resilience, and well-being. The non-arts-based program will include educational topics related to health, resilience, and well-being.

Eligibility 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

Primary outcomes:
measure: Change in Short Depression-Happiness Scale from Week 1 to Week 8
timeFrame: Weeks 1 and 8
measure: Change in Short Depression-Happiness Scale from Week 8 to Week 16
timeFrame: Weeks 8 and 16
measure: Change in Short Depression-Happiness Scale from Week 1 to Week 16
timeFrame: Weeks 1 and 16
measure: Change in Short Warwick-Edinburgh Mental Well-Being Scale from Week 1 to Week 8
timeFrame: Weeks 1 and 8
measure: Change in Short Warwick-Edinburgh Mental Well-Being Scale from Week 8 to Week 16
timeFrame: Weeks 8 and 16
measure: Change in Short Warwick-Edinburgh Mental Well-Being Scale from Week 1 to Week 16
timeFrame: Weeks 1 and 16
measure: Change in Brief Resilient Coping Scale from Week 1 to Week 8
timeFrame: Weeks 1 and 8
measure: Change in Brief Resilient Coping Scale from Week 8 to Week 16
timeFrame: Weeks 8 and 16
measure: Change in Brief Resilient Coping Scale from Week 1 to Week 16
timeFrame: Weeks 1 and 16
measure: Change in Godin-Shephard Leisure-Time Physical Activity Questionnaire from Week 1 to Week 8
timeFrame: Weeks 1 and 8
measure: Change in Godin-Shephard Leisure-Time Physical Activity Questionnaire from Week 8 to Week 16
timeFrame: Weeks 8 and 16
measure: Change in Godin-Shephard Leisure-Time Physical Activity Questionnaire from Week 1 to Week 16
timeFrame: Weeks 1 and 16
measure: Change in PROMIS Scale v1.2 - Global Health from Week 1 to Week 8
timeFrame: Weeks 1 and 8
measure: Change in PROMIS Scale v1.2 - Global Health from Week 8 to Week 16
timeFrame: Weeks 8 and 16
measure: Change in PROMIS Scale v1.2 - Global Health from Week 1 to Week 16
timeFrame: Weeks 1 and 16
measure: Change in Systolic and Diastolic Blood Pressure from Week 1 to Week 8
timeFrame: Weeks 1 and 8
measure: Change in Systolic and Diastolic Blood Pressure from Week 8 to Week 16
timeFrame: Weeks 8 and 16
measure: Change in Systolic and Diastolic Blood Pressure from Week 1 to Week 16
timeFrame: Weeks 1 and 16
measure: Change in Heart Rate from Week 1 to Week 8
timeFrame: Weeks 1 and 8
measure: Change in Heart Rate from Week 8 to Week 16
timeFrame: Weeks 8 and 16
measure: Change in Heart Rate from Week 1 to Week 16
timeFrame: Weeks 1 and 16
measure: Change in Pulse Oximetry from Week 1 to Week 8
timeFrame: Weeks 1 and 8
measure: Change in Pulse Oximetry from Week 8 to Week 16
timeFrame: Weeks 8 and 16
measure: Change in Pulse Oximetry from Week 1 to Week 16
timeFrame: Weeks 1 and 16
Secondary outcomes:
measure: Change in HeRe We Arts Survey from Week 1 to Week 8
timeFrame: Weeks 1 and 8
measure: Change in HeRe We Ed Survey from Week 1 to Week 8
timeFrame: Weeks 1 and 8
measure: Weekly Post-Session Survey
timeFrame: Weeks 1-8
Other outcomes:
measure: Weekly Take-Away Goals
timeFrame: Weeks 1-8
measure: Phone Interview
timeFrame: Week 9
measure: HeRe We Arts Week 16 Survey
timeFrame: Week 16
measure: HeRe We Ed Week 16 Survey
timeFrame: Week 16
Locations:
city: Euclid
country: United States
facility: Cleveland Clinic Euclid Hospital
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Lisa M Gallagher, MA
role: PRINCIPAL_INVESTIGATOR
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