NCT04245228

Brief Summary

Researchers are studying the effects of a health coaching intervention on the stress and burden of caregivers of patients awaiting heart or lung transplant.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2020

Longer than P75 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

January 14, 2020

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 28, 2020

Completed
5 months until next milestone

Study Start

First participant enrolled

June 13, 2020

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2023

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2023

Completed
10 months until next milestone

Results Posted

Study results publicly available

September 24, 2024

Completed
Last Updated

September 24, 2024

Status Verified

September 1, 2024

Enrollment Period

2.9 years

First QC Date

January 14, 2020

Results QC Date

March 28, 2024

Last Update Submit

September 18, 2024

Conditions

Stress, PsychologicalCaregiver Burden

Keywords

CaregiverHeart TransplantLung TransplantStress

Outcome Measures

Primary Outcomes (1)

  • Acceptability

    Percentage of participants who completed the study intervention

    after completion of the 12-week intervention or between 12-16 weeks after enrollment

Secondary Outcomes (1)

  • Perceived Stress Scale (PSS)

    after completion of the 12 week intervention or between 12-16 weeks after enrollment.

Study Arms (2)

Usual Care Group

NO INTERVENTION

Routine caregiver transplant education

Wellness Coaching Intervention

EXPERIMENTAL

Caregivers will be assigned a wellness coach

Behavioral: Wellness Coach

Interventions

Wellness CoachBEHAVIORAL

Trained in motivational interviewing who will call the patient weekly for 12 sessions for an approximately 30-minute intervention

Wellness Coaching Intervention

Eligibility Criteria

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

You may qualify if:

  • years or older who are the primary caregivers of patients listed (active, deferred, or temporarily inactive) for lung, heart/lung, or heart transplantation at Mayo Clinic in Rochester and Jacksonville, FL

You may not qualify if:

  • Individuals younger than 18 years
  • Non-English speaking, non-verbal, or extremely hard of hearing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55902, United States

Location

MeSH Terms

Conditions

Stress, PsychologicalCaregiver Burden

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Results Point of Contact

Title
Dr. Cassie Kennedy, PI
Organization
Mayo Clinic
kennedy.cassie@mayo.edu
1-507-284-2511

Study Officials

  • Cassie Kennedy, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 14, 2020

First Posted

January 28, 2020

Study Start

June 13, 2020

Primary Completion

April 30, 2023

Study Completion

November 30, 2023

Last Updated

September 24, 2024

Results First Posted

September 24, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)