NCT04924582

Brief Summary

The purpose of this research is to gather preliminary estimates of the impact of using Capacity Coaching as an intervention for patients receiving dialysis.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 4, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 14, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

July 23, 2021

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2023

Completed
Last Updated

April 10, 2024

Status Verified

April 1, 2024

Enrollment Period

1.9 years

First QC Date

June 4, 2021

Last Update Submit

April 9, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in Illness Intrusiveness Score at 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

Study Arms (2)

Capacity Coaching

EXPERIMENTAL

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.

Other: Capacity Coaching

No Capacity Coaching

NO INTERVENTION

Participants randomized to the No Capacity Coaching arm will receive usual care.

Interventions

Capacity Coaching focuses on developing the capacity within patients to adapt, endure, and function optimally in their lives along with illness and treatment.

Capacity Coaching

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Minors (under the age of 18 years).
  • Non-English speaking.
  • Lack the ability to provide informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

Study Officials

  • Kasey R Boehmer, MPH, PhD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 4, 2021

First Posted

June 14, 2021

Study Start

July 23, 2021

Primary Completion

June 20, 2023

Study Completion

June 20, 2023

Last Updated

April 10, 2024

Record last verified: 2024-04

Locations