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

    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic in Rochester

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.
Capacity Coaching focuses on developing the capacity within patients to adapt, endure, and function optimally in their lives along with illness and treatment.
No Intervention: No Capacity Coaching
Participants randomized to the No Capacity Coaching arm will receive usual care.

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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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.

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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