Caregiver Burden, Stress, Psychological
Conditions
Keywords
Caregiver, Heart Transplant, Lung Transplant, Stress
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.
Detailed description
This is a randomized trial of health coaching compared to usual care. Caregivers for patients on the adult heart or adult lung transplant waiting list at the Mayo Clinic will undergo informed consent. Consenting participants will be randomized to weekly, 30-minute telephone calls for twelve weeks or usual care. Questionnaires and demographic information will be collected at baseline and after 12 weeks.
Interventions
BEHAVIORALWellness Coach
Trained in motivational interviewing who will call the patient weekly for 12 sessions for an approximately 30-minute intervention
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 18 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
Exclusion criteria
* Individuals younger than 18 years * Non-English speaking, non-verbal, or extremely hard of hearing
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability | after completion of the 12-week intervention or between 12-16 weeks after enrollment | Percentage of participants who completed the study intervention |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Perceived Stress Scale (PSS) | after completion of the 12 week intervention or between 12-16 weeks after enrollment. | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Usual Care Group Routine caregiver transplant education | 30 |
| 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 | 30 |
| Total | 60 |
Baseline characteristics
| Characteristic | Usual Care Group | Wellness Coaching Intervention | Total |
|---|---|---|---|
| Age, Continuous | 62.3 years STANDARD_DEVIATION 7.2 | 61.9 years STANDARD_DEVIATION 7.1 | 62.1 years STANDARD_DEVIATION 7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 1 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 27 Participants | 25 Participants | 52 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 4 Participants | 6 Participants |
| Perceived Stress Scale (PSS) | 13.3 units on a scale STANDARD_DEVIATION 6.5 | 13.4 units on a scale STANDARD_DEVIATION 7.5 | 13.4 units on a scale STANDARD_DEVIATION 7 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) White | 28 Participants | 27 Participants | 55 Participants |
| Sex: Female, Male Female | 14 Participants | 13 Participants | 27 Participants |
| Sex: Female, Male Male | 16 Participants | 17 Participants | 33 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 30 |
| other Total, other adverse events | 0 / 30 | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 |
Outcome results
Primary
Acceptability
Percentage of participants who completed the study intervention
Time frame: 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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care Group | Acceptability | 30 Participants |
| Wellness Coaching Intervention | Acceptability | 27 Participants |
Secondary
Perceived Stress Scale (PSS)
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.
Time frame: after completion of the 12 week intervention or between 12-16 weeks after enrollment.
Population: Post intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care Group | Perceived Stress Scale (PSS) | 14.1 score on a scale | Standard Deviation 7.3 |
| Wellness Coaching Intervention | Perceived Stress Scale (PSS) | 13.0 score on a scale | Standard Deviation 8.2 |