Trial Outcomes & Findings for Patient-Provider Tools to Improve the Transition to Adult Care in Sickle Cell Disease (NCT NCT02200510)

NCT ID: NCT02200510

Last Updated: 2018-06-15

Results Overview

Name of Measure: Sickle Cell Self-Efficacy Scale (SCSES). Construct: sickle cell self-efficacy (disease specific self-efficacy) 9 item measure of sickle cell disease self-efficacy (likert scale from 1 \[not at all sure\] to 5 \[very sure\]) developed by Edwards (see References). Responses on items are summed to compute a total score. Minimum score: 9 Maximum score: 45 Higher scores represent higher sickle cell self-efficacy (better outcome).

Recruitment status

COMPLETED

Study phase

Target enrollment

78 participants

Primary outcome timeframe

baseline, 6 weeks (post-intervention)

Results posted on

2018-06-15

Participant Flow

Participant milestones

Participant milestones
Measure	Self-Management Group Self-management intervention for Adolescents with SCD - 6 week self-management group Self-management intervention for Adolescents with SCD: Chronic Disease Self-Management Program	Patient Portal Patient Portal Intervention for Adolescents with SCD - 6 week individual patient portal intervention Patient Portal Intervention for Adolescents with SCD: MyChart for SCD intervention
Overall Study STARTED	31	47
Overall Study COMPLETED	22	44
Overall Study NOT COMPLETED	9	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Self-Management Group Self-management intervention for Adolescents with SCD - 6 week self-management group Self-management intervention for Adolescents with SCD: Chronic Disease Self-Management Program	Patient Portal Patient Portal Intervention for Adolescents with SCD - 6 week individual patient portal intervention Patient Portal Intervention for Adolescents with SCD: MyChart for SCD intervention
Overall Study Death	1	1
Overall Study Protocol Violation	0	1
Overall Study Lost to Follow-up	7	1
Overall Study potential COI - joined study team	1	0

Baseline Characteristics

Patient-Provider Tools to Improve the Transition to Adult Care in Sickle Cell Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Self-Management Group n=22 Participants Self-management intervention for Adolescents with SCD - 6 week self-management group Self-management intervention for Adolescents with SCD: Chronic Disease Self-Management Program	Patient Portal n=44 Participants Patient Portal Intervention for Adolescents with SCD - 6 week individual patient portal intervention Patient Portal Intervention for Adolescents with SCD: MyChart for SCD intervention	Total n=66 Participants Total of all reporting groups
Age, Categorical <=18 years	13 Participants n=5 Participants	26 Participants n=7 Participants	39 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=5 Participants	18 Participants n=7 Participants	27 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	18.77 years STANDARD_DEVIATION 2.22 • n=5 Participants	18.82 years STANDARD_DEVIATION 2.72 • n=7 Participants	18.795 years STANDARD_DEVIATION 2.47 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	24 Participants n=7 Participants	34 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants	20 Participants n=7 Participants	32 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	22 Participants n=5 Participants	44 Participants n=7 Participants	66 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	22 Participants n=5 Participants	44 Participants n=7 Participants	66 Participants n=5 Participants

PRIMARY outcome

Timeframe: baseline, 6 weeks (post-intervention)

Population: Participants with completed baseline and post measures.

Outcome measures

Outcome measures
Measure	Self-Management Group n=22 Participants Self-management intervention for Adolescents with SCD - 6 week self-management group Self-management intervention for Adolescents with SCD: Chronic Disease Self-Management Program	Patient Portal n=44 Participants Patient Portal Intervention for Adolescents with SCD - 6 week individual patient portal intervention Patient Portal Intervention for Adolescents with SCD: MyChart for SCD intervention
Change From Baseline on Disease Self-efficacy Measure at 6 Weeks	33.2 units on a scale Standard Deviation 5.49	33.09 units on a scale Standard Deviation 7.10

Adverse Events

Self-Management Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

Patient Portal

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Lori Crosby

CincinnatiChildrens

Phone: 5136365380

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place