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This pilot study has two aims. The first aim is to establish the feasibility of coaching for caregivers of youth with spinal cord injury, and the second aim is to establish methodological procedures for a future multi-center study on the effectiveness of coaching as an intervention for caregivers of youth with spinal cord injury.
This study addresses the unmet needs of female primary informal caregivers of youth with spinal cord injury. A one-group pre-post treatment design will be used. Consented caregivers will receive coaching via face-to-face or via the phone. Each caregiver will participate in up to 10 coaching sessions. Each coaching session will last up to 90 minutes. Coaching sessions will be audiorecorded and transcribed verbatim. Outcomes of coaching on caregivers' self-identified goals will be assessed using the Canadian Occupational Performance Measure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| coaching in context | Other | 10, 1 hour sessions of face to face strength based coaching sessions provided face to face or over the phone. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| strength based coaching | Behavioral | strength based and solution focused coaching |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Canadian Occupational Performance Measure (COPM) | Rates self perceived performance and satisfaction with self-identified goals on a 10 point likert scale (1 cannot do, not satisfied; 10 can do without a problem, very satisfied). A 2-point change is considered clinically meaningful. | Baseline - before coaching and repeated at end of 10 coaching sessions (12 weeks from baseline) |
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Inclusion Criteria:
Exclusion Criteria:
This study is focused on primary female informal caregivers
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| Name | Affiliation | Role |
|---|---|---|
| MJ Mulcahey, PhD | Thomas Jefferson University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shriners Hospitals for Children | Chicago | Illinois | 60612 | United States | ||
| Shriners Hospitals for Children |
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| ID | Title | Description |
|---|---|---|
| FG000 | Coaching in Context | 10, 1 hour sessions of strength based coaching sessions provided face to face or via phone strength based coaching: strength based and solution focused coaching |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Coaching in Context | 10, 1 hour sessions of strength based coaching sessions strength based coaching: strength based and solution focused coaching |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Change in Canadian Occupational Performance Measure (COPM) | Rates self perceived performance and satisfaction with self-identified goals on a 10 point likert scale (1 cannot do, not satisfied; 10 can do without a problem, very satisfied). A 2-point change is considered clinically meaningful. | Posted | Mean | Standard Deviation | score on a scale | Baseline - before coaching and repeated at end of 10 coaching sessions (12 weeks from baseline) |
|
|
up to 10 weeks
10 Coaching sessions were provided over a period of up to 10 weeks, during which time adverse events were monitored.
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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 | Coaching in Context | 10, 1 hour sessions of strength based coaching via phone. strength based coaching: strength based and solution focused coaching |
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We did not achieve our desired sample size of 16. We originally planned to have an equal number of caregivers in each group, however caregivers did not want to be coached in person due to logistical challenges. The study is limited by the small sample size, and COPM scores were generated from more than one goal from each caregiver (there were 31 COPM goals across the 7 participants, with each participant contributing between 3-5 goals).
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. MJ Mulcahey | Thomas Jefferson University | 215-503-2888 | maryjane.mulcahey@jefferson.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 | Apr 4, 2021 | Apr 7, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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Pre-post coaching intervention
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| Philadelphia |
| Pennsylvania |
| 19438 |
| United States |
| TIRR Memorial Hermann Rehabilitation Hospital | Houston | Texas | 77030 | United States |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Canadian Occupational Performance Measure | Semi-structure interview in which clients identified goals for coaching. For each goal, performance and satisfaction are scored on a scale between 1-10, where 1 is "cannot do" and "very unsatisfied" and 10 is "can do without a problem" and "very satisfied". The mean performance and satisfaction scores for each participant are calculated, and the mean of the means is calculated for group scores. | Mean | Full Range | units on a scale |
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| Participants |
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| 0 |
| 9 |
| 0 |
| 9 |
| 0 |
| 9 |
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| D014947 | Wounds and Injuries |