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

• ClinicalTrials.gov Identifier: NCT02200510
• Recruitment Status: Completed
• First Posted: July 25, 2014
• Results First Posted: June 15, 2018
• Last Update Posted: June 15, 2018
• Sponsor: Children's Hospital Medical Center, Cincinnati
• Information provided by (Responsible Party): Children's Hospital Medical Center, Cincinnati

• Study Type: Interventional
• Study Design: Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Sickle Cell Disease
• Interventions: Behavioral: Self-management intervention for Adolescents with SCD; Behavioral: Patient Portal Intervention for Adolescents with SCD
• Enrollment: 78

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Self-Management Group	Patient Portal
Arm/Group Description	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 Intervention for Adolescents with SCD - 6 week individual patient portal intervention Patient Portal Intervention for Adolescents with SCD: MyChart for SCD intervention
Period Title: Overall Study
Started	31 [1]	47 [2]
Completed	22 [3]	44 [4]
Not Completed	9	3
Reason Not Completed
Death	1	1
Protocol Violation	0	1
Lost to Follow-up	7	1
potential COI - joined study team	1	0
[1] Number who only completed self-management or completed it before portal (could do 6 months later).; [2] Number who only completed portal or completed it before self-management (could do 6 months later).; [3] This is the number of participants with baseline and post data.; [4] This number is the number of participants with both baseline and post data.

Baseline Characteristics

Arm/Group Title		Self-Management Group	Patient Portal	Total
Arm/Group Description		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 Intervention for Adolescents with SCD - 6 week individual patient portal intervention Patient Portal Intervention for Adolescents with SCD: MyChart for SCD intervention	Total of all reporting groups
Overall Number of Baseline Participants		22	44	66
Baseline Analysis Population Description		Participants who completed baseline measures
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	22 participants	44 participants	66 participants
	<=18 years	13 59.1%	26 59.1%	39 59.1%
	Between 18 and 65 years	9 40.9%	18 40.9%	27 40.9%
	>=65 years	0 0.0%	0 0.0%	0 0.0%
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	22 participants	44 participants	66 participants
		18.77 (2.22)	18.82 (2.72)	18.795 (2.47)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	22 participants	44 participants	66 participants
	Female	10 45.5%	24 54.5%	34 51.5%
	Male	12 54.5%	20 45.5%	32 48.5%
Race (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	22 participants	44 participants	66 participants
	American Indian or Alaska Native	0 0.0%	0 0.0%	0 0.0%
	Asian	0 0.0%	0 0.0%	0 0.0%
	Native Hawaiian or Other Pacific Islander	0 0.0%	0 0.0%	0 0.0%
	Black or African American	22 100.0%	44 100.0%	66 100.0%
	White	0 0.0%	0 0.0%	0 0.0%
	More than one race	0 0.0%	0 0.0%	0 0.0%
	Unknown or Not Reported	0 0.0%	0 0.0%	0 0.0%
Region of Enrollment; Measure Type: Count of Participants; Unit of measure: Participants
United States	Number Analyzed	22 participants	44 participants	66 participants
		22 100.0%	44 100.0%	66 100.0%

Outcome Measures

1. Primary Outcome

Title	Change From Baseline on Disease Self-efficacy Measure at 6 Weeks
Description	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).
Time Frame	baseline, 6 weeks (post-intervention)

Outcome Measure Data

Analysis Population Description

Participants with completed baseline and post measures.

Arm/Group Title	Self-Management Group	Patient Portal
Arm/Group Description:	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 Intervention for Adolescents with SCD - 6 week individual patient portal intervention Patient Portal Intervention for Adolescents with SCD: MyChart for SCD intervention
Overall Number of Participants Analyzed	22	44
Mean (Standard Deviation); Unit of Measure: units on a scale
	33.2 (5.49)	33.09 (7.10)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Self-Management Group
	Comments	[Not Specified]
	Type of Statistical Test	Equivalence
	Comments	Because this was a pilot study, the goal was to detect effects sizes for a larger R01 or R21.
Statistical Test of Hypothesis	P-Value	0.575
	Comments	[Not Specified]
	Method	ANOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.33
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Patient Portal
	Comments	[Not Specified]
	Type of Statistical Test	Equivalence
	Comments	Because this was a pilot study, the goal was to detect effects sizes for a larger R01 or R21.
Statistical Test of Hypothesis	P-Value	0.721
	Comments	[Not Specified]
	Method	ANOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	.138
	Estimation Comments	[Not Specified]

Adverse Events

Time Frame	During the 6 months participants were enrolled in the study.
Adverse Event Reporting Description	An adverse event (AE) for the current study is an unfavorable medical occurrence in a participant temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research. A serious adverse event (SAE) may or may not result in death, be life threatening, or require hospitalization. Since this population has frequent hospitalizations, only unexpected adverse events were reported here.
Arm/Group Title	Self-Management Group	Patient Portal
Arm/Group Description	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 Intervention for Adolescents with SCD - 6 week individual patient portal intervention Patient Portal Intervention for Adolescents with SCD: MyChart for SCD intervention
All-Cause Mortality
	Self-Management Group	Patient Portal
	Affected / at Risk (%)	Affected / at Risk (%)
Total	1/22 (4.55%)	0/44 (0.00%)
Serious Adverse Events
	Self-Management Group	Patient Portal
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/22 (0.00%)	0/44 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	4%
	Self-Management Group	Patient Portal
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/22 (0.00%)	0/44 (0.00%)

Limitations and Caveats

Pilot feasibility studies with convenience samples.

More Information

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

• Name/Title: Lori Crosby
• Organization: CincinnatiChildrens
• Phone: 5136365380
• EMail: lori.crosby@cchmc.org

Publications of Results:

Crosby LE, Joffe NE, Dunseath LA, Lee R. Design Joins the Battle Against Sickle-cell Disease. Des Manage Rev. 2013 Summer;24(2):48-53. doi: 10.1111/drev.10241. No abstract available.

Crosby, L.E., Hudepohl, M., Kalinyak, K., Britto, M., Goldstein, A., Brown, K., Culp, A., & Joiner, C. H. (2013). Impact of use of a disease-specific patient portal on transition readiness and quality of life in adolescents with sickle cell disease [Abstract]. Blood, 122(21), 2982.

Crosby, L. E., Joffe, N., Kalinyak, K., Bruck, A. & Joiner, C. H. (2013). Six-month data from a pilot self-management intervention for adolescents with sickle cell disease [Abstract]. Blood, 122(21), 1675.

Other Publications:

Crosby LE, Smith T, Parr WD, Mitchell MJ. The Community Engagement and Translational Research Speaker Series: An Innovative Model of Health Education. J Community Med Health Educ. 2013 Jul 24;3:1000227. doi: 10.4172/2161-0711.1000227.

Edwards R, Telfair J, Cecil H, Lenoci J. Reliability and validity of a self-efficacy instrument specific to sickle cell disease. Behav Res Ther. 2000 Sep;38(9):951-63. doi: 10.1016/s0005-7967(99)00140-0.

• Responsible Party: Children's Hospital Medical Center, Cincinnati
• ClinicalTrials.gov Identifier: NCT02200510
• Other Study ID Numbers: 5K07HL108720 ( U.S. NIH Grant/Contract )
• First Submitted: July 21, 2014
• First Posted: July 25, 2014
• Results First Submitted: February 9, 2018
• Results First Posted: June 15, 2018
• Last Update Posted: June 15, 2018