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| ID | Type | Description | Link |
|---|---|---|---|
| R03HL155040 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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Researchers are studying the effects of a health coaching intervention on the stress and burden of caregivers of patients awaiting heart or lung transplant.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Care Group | No Intervention | Routine caregiver transplant education | |
| Wellness Coaching Intervention | Experimental | Caregivers will be assigned a wellness coach |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Wellness Coach | Behavioral | Trained in motivational interviewing who will call the patient weekly for 12 sessions for an approximately 30-minute intervention |
|
| Measure | Description | Time Frame |
|---|---|---|
| Acceptability | Percentage of participants who completed the study intervention | after completion of the 12-week intervention or between 12-16 weeks after enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cassie Kennedy, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55902 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Usual Care Group | Routine caregiver transplant education |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Usual Care Group | Routine caregiver transplant education |
| BG001 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Acceptability | Percentage of participants who completed the study intervention | Study participants in health coaching or usual care group at the end of study | Posted | Count of Participants | Participants | after completion of the 12-week intervention or between 12-16 weeks after enrollment |
|
Participants were active in the study for 16 weeks.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Usual Care Group | Routine caregiver transplant education | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Cassie Kennedy, PI | Mayo Clinic | 1-507-284-2511 | kennedy.cassie@mayo.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 20, 2020 | Mar 29, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D013315 | Stress, Psychological |
| D000084802 | Caregiver Burden |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| after completion of the 12 week intervention or between 12-16 weeks after enrollment. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| 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. | Mean | Standard Deviation | units on a scale |
|
|
|
| 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. | Post intervention | Posted | Mean | Standard Deviation | score on a scale | after completion of the 12 week intervention or between 12-16 weeks after enrollment. |
|
|
|
| 30 |
| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | 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 | 0 | 30 | 0 | 30 | 0 | 30 |
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