Evaluating the Need and Impact of a Multifaceted Wellness Program on the Health Related Quality of Life (HRQOL), Disease Activity, and Healthcare Utilization in Female Patients With Inflammatory Bowel Disease: Phase II - The Impact
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Mayo Clinic
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Impact of Wellness program on Quality of Life
Study Overview
Brief Summary
Researchers want to understand if a combination of usual medical care along with a wellness program designed for women with Inflammatory Bowel Disease diagnosis will have an effect on quality of life, stress, and disease activity.
Detailed Description
It will take a year to complete the study and involves subjects participating in a Wellness program, wellness coaching and completion of surveys. Subjects will be requested to complete wellness classes along with one wellness coaching session within the first two months of study participation, and continue their year long participation of wellness coaching sessions and surveys.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 64 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Female patient with a diagnosis of Ulcerative Colitis or Crohn's Disease seen in the Inflammatory Bowel Disease clinic in the Division of Gastroenterology and Hepatology at Mayo Clinic in Rochester.
- •Who are between 18-64 years of age.
- •Ability to provide informed consent.
- •Ability to complete all aspects of this trial.
Exclusion Criteria
- •Female patients with a diagnosis of Ulcerative Colitis or Crohn's Disease with medical co-morbidity or factor judged by the investigator to preclude participation in the study or which might hinder adherence.
- •Participation in another organized wellness program.
Arms & Interventions
Healthy Living Program
In addition to usual clinical Inflammatory Bowel Disease medical care, subjects will participate in a Wellness Program.
Intervention: Wellness Program (Behavioral)
Healthy Living Program
In addition to usual clinical Inflammatory Bowel Disease medical care, subjects will participate in a Wellness Program.
Intervention: Wellness Coaching (Behavioral)
Outcomes
Primary Outcomes
Impact of Wellness program on Quality of Life
Time Frame: Baseline day 1 to 12 months end of study
Health Related Quality of life over the study will be determined by changes through subject completion of the Short Form 12 scoring from 0 to 100, with higher scores indicating better physical and mental health functioning.
Secondary Outcomes
No secondary outcomes reported
Investigators
Laura E. Raffals, M.D
Principal Investigator
Mayo Clinic