- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04924582
Learning From Our Patients, Learning From Our Practice: Implementing an Intervention to Support Patients on Dialysis
July 14, 2023 updated by: Kasey R. Boehmer, Mayo Clinic
The purpose of this research is to gather preliminary estimates of the impact of using Capacity Coaching as an intervention for patients receiving dialysis.
Study Overview
Status
Enrolling by invitation
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
86
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Minnesota
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Rochester, Minnesota, United States, 55905
- Mayo Clinic in Rochester
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
Clinician Participants:
- Clinicians employed at Mayo Clinic who provide care to patients visiting the Mayo Clinic - Department of Nephrology and Hypertension Dialysis Services.
Patient Participants:
- Adult patients (18 years of age and older).
- Receive long-term dialysis treatment and services at Mayo Clinic.
Exclusion Criteria:
- Minors (under the age of 18 years).
- Non-English speaking.
- Lack the ability to provide informed consent.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Capacity Coaching
Participants randomized to the Capacity Coaching arm will receive three months of coaching with a Health and Wellness coach.
They will receive one one-hour session and five half-hour sessions approximately two weeks apart.
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Capacity Coaching focuses on developing the capacity within patients to adapt, endure, and function optimally in their lives along with illness and treatment.
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No Intervention: No Capacity Coaching
Participants randomized to the No Capacity Coaching arm will receive usual care.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Illness Intrusiveness Score at Baseline, 3 Months, 6 Months
Time Frame: Baseline, 3 Months, 6 Months
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The extent to which a person's illness and treatment impact their life.
The Illness Intrusiveness Score ranges from 13-91, with a higher score indicating worse outcome.
|
Baseline, 3 Months, 6 Months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Kasey R Boehmer, MPH, PhD, Mayo Clinic
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 23, 2021
Primary Completion (Estimated)
December 1, 2023
Study Completion (Estimated)
December 1, 2023
Study Registration Dates
First Submitted
June 4, 2021
First Submitted That Met QC Criteria
June 9, 2021
First Posted (Actual)
June 14, 2021
Study Record Updates
Last Update Posted (Actual)
July 17, 2023
Last Update Submitted That Met QC Criteria
July 14, 2023
Last Verified
July 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- 21-001884
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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