Trial Outcomes & Findings for Wellness Coaching for Caregivers of Thoracic Transplant Candidates (NCT NCT04245228)

NCT ID: NCT04245228

Last Updated: 2024-09-24

Results Overview

Percentage of participants who completed the study intervention

Recruitment status

COMPLETED

Study phase

Target enrollment

60 participants

Primary outcome timeframe

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

Results posted on

2024-09-24

Participant Flow

Participant milestones

Participant milestones
Measure	Usual Care Group Routine caregiver transplant education	Wellness Coaching Intervention Caregivers will be assigned a wellness coach Wellness Coach: Trained in motivational interviewing who will call the patient weekly for 12 sessions for an approximately 30-minute intervention
Overall Study STARTED	30	30
Overall Study COMPLETED	30	27
Overall Study NOT COMPLETED	0	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Wellness Coaching for Caregivers of Thoracic Transplant Candidates

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Usual Care Group n=30 Participants Routine caregiver transplant education	Wellness Coaching Intervention n=30 Participants Caregivers will be assigned a wellness coach Wellness Coach: Trained in motivational interviewing who will call the patient weekly for 12 sessions for an approximately 30-minute intervention	Total n=60 Participants Total of all reporting groups
Age, Continuous	62.3 years STANDARD_DEVIATION 7.2 • n=99 Participants	61.9 years STANDARD_DEVIATION 7.1 • n=107 Participants	62.1 years STANDARD_DEVIATION 7.0 • n=206 Participants
Sex: Female, Male Female	14 Participants n=99 Participants	13 Participants n=107 Participants	27 Participants n=206 Participants
Sex: Female, Male Male	16 Participants n=99 Participants	17 Participants n=107 Participants	33 Participants n=206 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=99 Participants	1 Participants n=107 Participants	2 Participants n=206 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	27 Participants n=99 Participants	25 Participants n=107 Participants	52 Participants n=206 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=99 Participants	4 Participants n=107 Participants	6 Participants n=206 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=99 Participants	0 Participants n=107 Participants	1 Participants n=206 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants	1 Participants n=107 Participants	1 Participants n=206 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Black or African American	0 Participants n=99 Participants	1 Participants n=107 Participants	1 Participants n=206 Participants
Race (NIH/OMB) White	28 Participants n=99 Participants	27 Participants n=107 Participants	55 Participants n=206 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=99 Participants	1 Participants n=107 Participants	2 Participants n=206 Participants
Perceived Stress Scale (PSS)	13.3 units on a scale STANDARD_DEVIATION 6.5 • n=99 Participants	13.4 units on a scale STANDARD_DEVIATION 7.5 • n=107 Participants	13.4 units on a scale STANDARD_DEVIATION 7.0 • n=206 Participants

PRIMARY outcome

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

Population: Study participants in health coaching or usual care group at the end of study

Percentage of participants who completed the study intervention

Outcome measures

Outcome measures
Measure	Usual Care Group n=30 Participants Routine caregiver transplant education	Wellness Coaching Intervention n=30 Participants Caregivers will be assigned a wellness coach Wellness Coach: Trained in motivational interviewing who will call the patient weekly for 12 sessions for an approximately 30-minute intervention
Acceptability	30 Participants	27 Participants

SECONDARY outcome

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

Population: Post intervention

Perceived Stress Scale-10 (PSS-10) is a 10-item tool to evaluate perception of stress during the past month (Cronbach α: 0.74-0.91). The Perceived Stress Scale (PSS) is a self-assessment tool used to measure stress. Individual scores can range from 0 to 40 with higher scores indicating higher perceived stress. Questions are scored 0-4 with scores of 0-13 indicate low; 14-26 indicate moderate; and 27 and above indicate high stress. We will evaluate the PSS of intervention group compared to the change in PSS for the usual care.

Outcome measures

Outcome measures
Measure	Usual Care Group n=30 Participants Routine caregiver transplant education	Wellness Coaching Intervention n=27 Participants Caregivers will be assigned a wellness coach Wellness Coach: Trained in motivational interviewing who will call the patient weekly for 12 sessions for an approximately 30-minute intervention
Perceived Stress Scale (PSS)	14.1 score on a scale Standard Deviation 7.3	13.0 score on a scale Standard Deviation 8.2

Adverse Events

Usual Care Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Wellness Coaching Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Cassie Kennedy, PI

Mayo Clinic

Phone: 1-507-284-2511

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place