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NCT05172557 Clinical Trial

IBD and Women's Health Wellness Program

Ulcerative Colitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05172557
Other study ID # 21-002100
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 14, 2022
Est. completion date December 26, 2023

Study information
Verified date December 2023
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 50
Est. completion date December 26, 2023
Est. primary completion date December 26, 2023
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 64 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• Wellness Program
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
• Wellness Coaching
Wellness coaching sessions throughout 12 months of study participation

Locations
Country Name City State
United States Mayo Clinic in Rochester Rochester Minnesota

Sponsors (1)
Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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. Baseline day 1 to 12 months end of study
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