Back to resultsIBD and Women's Health Wellness Program
Primary Purpose
Inflammatory Bowel Diseases, Ulcerative Colitis, Crohn Disease
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Wellness Program
Wellness Coaching
Sponsored by
About this trial
This is an interventional other trial for Inflammatory Bowel Diseases
Eligibility Criteria
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.
Sites / Locations
- Mayo Clinic in RochesterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Healthy Living Program
Arm Description
In addition to usual clinical Inflammatory Bowel Disease medical care, subjects will participate in a Wellness Program.
Outcomes
Primary Outcome Measures
Impact of Wellness program on Quality of Life
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 Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05172557
Brief Title
IBD and Women's Health Wellness Program
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 14, 2022 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Bowel Diseases, Ulcerative Colitis, Crohn Disease
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Healthy Living Program
Arm Type
Experimental
Arm Description
In addition to usual clinical Inflammatory Bowel Disease medical care, subjects will participate in a Wellness Program.
Intervention Type
Behavioral
Intervention Name(s)
Wellness Program
Intervention Description
Wellness Program involves participation in classes with topics involving resiliency, stress, physical activity, and nutrition to be completed within a few months of study participation
Intervention Type
Behavioral
Intervention Name(s)
Wellness Coaching
Intervention Description
Wellness coaching sessions throughout 12 months of study participation
Primary Outcome Measure Information:
Title
Impact of Wellness program on Quality of Life
Description
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.
Time Frame
Baseline day 1 to 12 months end of study
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Katie A Cruz
Phone
507-284-5404
Email
GIMResearchStudies@mayo.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Shawn C Fokken, CCRP
Phone
507-293-2740
Email
GIMResearchStudies@mayo.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laura Raffals, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shawn C Fokken, CCRP
Phone
507-293-2740
Email
GIMResearchStudies@mayo.edu
First Name & Middle Initial & Last Name & Degree
Katie A Cruz
Phone
507-284-5404
Email
GIMResearchStudies@mayo.edu
First Name & Middle Initial & Last Name & Degree
Laura Raffals, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
IBD and Women's Health Wellness Program
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