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Coaching for Caregivers of Children With Spinal Cord Injury

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03898700
Recruitment Status : Completed
First Posted : April 2, 2019
Results First Posted : April 18, 2023
Last Update Posted : April 18, 2023
Sponsor:
Information provided by (Responsible Party):
Thomas Jefferson University

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Other
Condition Spinal Cord Injuries
Intervention Behavioral: strength based coaching
Enrollment 9
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Coaching in Context
Hide Arm/Group Description

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
Period Title: Overall Study
Started 9
Completed 7
Not Completed 2
Reason Not Completed
Withdrawal by Subject             2
Arm/Group Title Coaching in Context
Hide Arm/Group Description

10, 1 hour sessions of strength based coaching sessions

strength based coaching: strength based and solution focused coaching
Overall Number of Baseline Participants 9
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants
<=18 years
0
   0.0%
Between 18 and 65 years
9
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 9 participants
37.14  (5.15)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants
Female
9
 100.0%
Male
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants
Hispanic or Latino
1
  11.1%
Not Hispanic or Latino
8
  88.9%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
3
  33.3%
White
6
  66.7%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Canadian Occupational Performance Measure   [1] 
Mean (Full Range)
Unit of measure:  Units on a scale
 Number Analyzed 9 participants
Performance Score
4.23
(1 to 8)
Satisfaction Score
3.97
(1 to 8)
[1]
Measure Description: 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.
1.Primary Outcome
Title Change in Canadian Occupational Performance Measure (COPM)
Hide Description 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.
Time Frame Baseline - before coaching and repeated at end of 10 coaching sessions (12 weeks from baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Coaching in Context
Hide Arm/Group Description:

10, 1 hour sessions of strength based coaching sessions

strength based coaching: strength based and solution focused coaching
Overall Number of Participants Analyzed 7
Mean (Standard Deviation)
Unit of Measure: score on a scale
COPM Performance 2.48  (2.01)
COPM Satisfaction 2.80  (1.33)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Coaching in Context
Comments This one-group feasibility study examined outcomes of coaching using descriptive statistics (changed score) and the Wilcoxon signed-rank test. A changed score of 2 points reflects clinical significance. The Wilcoxon was used to determine statistical significance. Performance scores from 31 coaching goals across 7 informal caregivers were used for analysis.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value 2
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Coaching in Context
Comments This one-group feasibility study examined outcomes of coaching using descriptive statistics (changed score) and the Wilcoxon signed-rank test. A changed score of 2 points reflects clinical significance. The Wilcoxon was used to determine statistical significance. Satisfaction scores from 31 coaching goals across 7 informal caregivers were used for analysis.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Net)
Estimated Value 2
Estimation Comments [Not Specified]
Time Frame up to 10 weeks
Adverse Event Reporting Description 10 Coaching sessions were provided over a period of up to 10 weeks, during which time adverse events were monitored.
 
Arm/Group Title Coaching in Context
Hide Arm/Group Description

10, 1 hour sessions of strength based coaching via phone.

strength based coaching: strength based and solution focused coaching
All-Cause Mortality
Coaching in Context
Affected / at Risk (%)
Total   0/9 (0.00%) 
Hide Serious Adverse Events
Coaching in Context
Affected / at Risk (%)
Total   0/9 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Coaching in Context
Affected / at Risk (%)
Total   0/9 (0.00%) 
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).
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. MJ Mulcahey
Organization: Thomas Jefferson University
Phone: 215-503-2888
EMail: maryjane.mulcahey@jefferson.edu
Layout table for additonal information
Responsible Party: Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT03898700    
Other Study ID Numbers: 533863
First Submitted: January 22, 2019
First Posted: April 2, 2019
Results First Submitted: April 14, 2021
Results First Posted: April 18, 2023
Last Update Posted: April 18, 2023