Trial Outcomes & Findings for Family Champions Project (NCT NCT05298345)
NCT ID: NCT05298345
Last Updated: 2025-11-21
Results Overview
Do FCP participants exhibit higher retention rates (i.e., completion %) after cycles of CQI? • Measured by program status (% active, complete, or not in program) as recorded on the nFORM online data collection system whose use is required by the funder to track programmatic data, such as enrollment and participation levels. Count of participants who dropped out before CQI efforts began was obtained Count of participants who dropped out after CQI efforts began was obtained Count of participant completions before CQI efforts began was obtained Count of participant completions after CQI efforts began was obtained
COMPLETED
NA
1111 participants
through study completion, an average of six weeks
2025-11-21
Participant Flow
Participant milestones
| Measure |
Primary Workshop Sessions
Participants receive 18 total workshop hours; TYRO Leadership curriculum in 6 2-hour weekly sessions for a subtotal of 12 hours, and Core Communication curriculum in 1-3 sessions for a subtotal of 6 hours.
Family Champions Project Primary Services: Primary Services: participants receive 12 hours of TYRO Leadership curricula, 6 hours of Core Communication curricula.
Support Services (optional): participants choose from a menu of classes (1-3 hours) at the walk-in mini clinic to meet a variety of self-identified needs.
|
|---|---|
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Overall Study
STARTED
|
1111
|
|
Overall Study
COMPLETED
|
1111
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Family Champions Project
Baseline characteristics by cohort
| Measure |
Primary Workshop Sessions
n=1111 Participants
Participants receive 18 total workshop hours; TYRO Leadership curriculum in 6 2-hour weekly sessions for a subtotal of 12 hours, and Core Communication curriculum in 1-3 sessions for a subtotal of 6 hours.
Family Champions Project Primary Services: Primary Services: participants receive 12 hours of TYRO Leadership curricula, 6 hours of Core Communication curricula.
Support Services (optional): participants choose from a menu of classes (1-3 hours) at the walk-in mini clinic to meet a variety of self-identified needs.
|
|---|---|
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Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1088 Participants
n=39 Participants
|
|
Age, Categorical
>=65 years
|
23 Participants
n=39 Participants
|
|
Age, Continuous
|
39.93 years
n=39 Participants
|
|
Sex: Female, Male
Female
|
944 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
167 Participants
n=39 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
44 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Asian
|
11 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
11 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Black or African American
|
211 Participants
n=39 Participants
|
|
Race (NIH/OMB)
White
|
667 Participants
n=39 Participants
|
|
Race (NIH/OMB)
More than one race
|
167 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
PRIMARY outcome
Timeframe: through study completion, an average of six weeksPopulation: These numbers are inconsistent with numbers provided in the rows in the Participant Flow module due to the number of participants who were included in the sample of the study (which is much smaller than the overall number enrolled). This is due to the study only looking at a portion of the study where this process was implemented.
Do FCP participants exhibit higher retention rates (i.e., completion %) after cycles of CQI? • Measured by program status (% active, complete, or not in program) as recorded on the nFORM online data collection system whose use is required by the funder to track programmatic data, such as enrollment and participation levels. Count of participants who dropped out before CQI efforts began was obtained Count of participants who dropped out after CQI efforts began was obtained Count of participant completions before CQI efforts began was obtained Count of participant completions after CQI efforts began was obtained
Outcome measures
| Measure |
Primary Workshop Sessions
n=187 Participants
Participants receive 18 total workshop hours; TYRO Leadership curriculum in 6 2-hour weekly sessions for a subtotal of 12 hours, and Core Communication curriculum in 1-3 sessions for a subtotal of 6 hours.
Family Champions Project Primary Services: Primary Services: participants receive 12 hours of TYRO Leadership curricula, 6 hours of Core Communication curricula.
Support Services (optional): participants choose from a menu of classes (1-3 hours) at the walk-in mini clinic to meet a variety of self-identified needs.
|
|---|---|
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Primary Outcome Measure 1: Retention Rates Among Participants
# of dropouts pre intervention
|
20 Participants
|
|
Primary Outcome Measure 1: Retention Rates Among Participants
# of dropouts post-intervention
|
13 Participants
|
|
Primary Outcome Measure 1: Retention Rates Among Participants
# of completions pre intervention
|
76 Participants
|
|
Primary Outcome Measure 1: Retention Rates Among Participants
# of completions post-intervention
|
78 Participants
|
SECONDARY outcome
Timeframe: pre to post completion which is 6 weeks longsDo FCP participants exhibit healthier partner relationship attitudes after enrolling in the program? * 5 survey items measure the reported frequency of agreement with healthy partner relationship attitudes on a 4-point scale (1 'Strongly Agree', 2 'Agree', 3 'Disagree', 4, 'Strongly Disagree', NA 'Not Applicable'). * Lower scores on all items are positive (ex. - I want to grow old with my partner.) The 5 items are measured as a construct. All items are added together and divided by 5 to create the construct score. The higher the score, the better the outcome. maximum score of 5.0, minimum score of 1.0
Outcome measures
| Measure |
Primary Workshop Sessions
n=485 Participants
Participants receive 18 total workshop hours; TYRO Leadership curriculum in 6 2-hour weekly sessions for a subtotal of 12 hours, and Core Communication curriculum in 1-3 sessions for a subtotal of 6 hours.
Family Champions Project Primary Services: Primary Services: participants receive 12 hours of TYRO Leadership curricula, 6 hours of Core Communication curricula.
Support Services (optional): participants choose from a menu of classes (1-3 hours) at the walk-in mini clinic to meet a variety of self-identified needs.
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|---|---|
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Secondary Outcome Measure 1: Partner Relationship Attitudes
mean at baseline
|
3.22 score on a scale
Standard Deviation .707
|
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Secondary Outcome Measure 1: Partner Relationship Attitudes
mean at follow-up
|
3.50 score on a scale
Standard Deviation .611
|
Adverse Events
Primary Workshop Sessions
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place