Improving Self-Management in Adolescents With Sickle Cell Disease (SCThrive)

• ClinicalTrials.gov Identifier: NCT02851615
• Recruitment Status: Completed
• First Posted: August 1, 2016
• Results First Posted: March 17, 2021
• Last Update Posted: March 17, 2021
• Sponsor: Children's Hospital Medical Center, Cincinnati
• Information provided by (Responsible Party): Children's Hospital Medical Center, Cincinnati

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Treatment
• Condition: Sickle Cell Disease
• Intervention: Behavioral: SCThrive Intervention for Adolescents with SCD
• Enrollment: 66

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	SCThrive	Attention Control
Arm/Group Description	SCThrive Intervention for Adolescents with SCD - 6 week self-management group SCThrive Intervention for Adolescents with SCD: Chronic Disease Self-Management Program	6 weekly 15-20 minute individual phone calls on educational topics. No interventions are included in this arm.
Period Title: Overall Study
Started	27	31
Completed	26	27
Not Completed	1	4
Reason Not Completed
Cognitive Issue	1	0
Lost to Follow-up	0	4

Baseline Characteristics

Arm/Group Title		SCThrive	Attention Control	Total
Arm/Group Description		SCThrive Intervention for Adolescents with SCD - 6 week self-management group SCThrive Intervention for Adolescents with SCD: Chronic Disease Self-Management Program	6 weekly 15-20 minute individual phone calls on educational topics. No interventions are included in this arm.	Total of all reporting groups
Overall Number of Baseline Participants		27	31	58
Baseline Analysis Population Description		[Not Specified]
Age, Continuous [1]; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	26 participants	27 participants	53 participants
		16.7 (2.3)	16.3 (2.5)	16.5 (2.4)
		[1] Measure Analysis Population Description: One participant in SC Thrive did not complete the intervention due to a cognitive issue (n=1). Four participants in Attention Control did not complete the intervention and were lost to follow-up (n=4).
Sex: Female, Male [1]; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	26 participants	27 participants	53 participants
	Female	14 53.8%	14 51.9%	28 52.8%
	Male	12 46.2%	13 48.1%	25 47.2%
		[1] Measure Analysis Population Description: One participant in SC Thrive did not complete the intervention due to a cognitive issue (n=1). Four participants in Attention Control did not complete the intervention and were lost to follow-up (n=4).
Ethnicity (NIH/OMB) [1]; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	26 participants	27 participants	53 participants
	Hispanic or Latino	0 0.0%	0 0.0%	0 0.0%
	Not Hispanic or Latino	26 100.0%	27 100.0%	53 100.0%
	Unknown or Not Reported	0 0.0%	0 0.0%	0 0.0%
		[1] Measure Analysis Population Description: One participant in SC Thrive did not complete the intervention due to a cognitive issue (n=1). Four participants in Attention Control did not complete the intervention and were lost to follow-up (n=4).
Race (NIH/OMB) [1]; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	26 participants	27 participants	53 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	26 100.0%	27 100.0%	53 100.0%
	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%
		[1] Measure Analysis Population Description: One participant in SC Thrive did not complete the intervention due to a cognitive issue (n=1). Four participants in Attention Control did not complete the intervention and were lost to follow-up (n=4).
Region of Enrollment; Measure Type: Count of Participants; Unit of measure: Participants
United States	Number Analyzed	27 participants	31 participants	58 participants
		27 100.0%	31 100.0%	58 100.0%

Outcome Measures

1. Primary Outcome

Title	Scores on Behavioral Activation Measure at Baseline and 6 Weeks (Post-treatment)
Description	Participants complete the Patient Activation Measure (PAM-13), which is a 13 item measure on skills, knowledge, confidence and readiness for self-management developed by Hibbard et al., 2005. Items are rated on a 4-point Likert scale of 1 = "Disagree Strongly" to 3 = "Strongly Agree." Raw scores range from 13 to 52 and are converted to scores that range from 0 to 100. This score was then divided into four levels of activation, which reflect a developmental progression from being passive with regard to one's health to being proactive: Level 1 (score of 0.0 - 47.0), Level 2 (47.1 - 55.1), Level 3 (55.2 - 72.4), and Level 4 (72.5 - 100). Higher scores indicate more behavioral activation.
Time Frame	baseline, 6 weeks (post-treatment)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	SCThrive	Attention Control
Arm/Group Description:	SCThrive Intervention for Adolescents with SCD - 6 week self-management group SCThrive Intervention for Adolescents with SCD: Chronic Disease Self-Management Program	6 weekly 15-20 minute individual phone calls on educational topics. No interventions are included in this arm.
Overall Number of Participants Analyzed	26	27
Mean (Standard Deviation); Unit of Measure: score on a scale
Baseline Scores	68.48 (15.47)	69.13 (20.75)
Post- Treatment Scores	76.57 (15.04)	68.82 (18.18)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	SCThrive, Attention Control
	Comments	We conducted separate mixed ANOVA analyses to assess for the effects of group (SCThrive/SCHealthEd), time (baseline/post-treatment), and group x time interaction for the PAM-13.
	Type of Statistical Test	Superiority
	Comments	Power analyses were calculated on the PAM-13, our primary outcome measure. Analyses were conducted using the internal Monte Carlo simulation capabilities of Mplus (Version 1.20). Based on the effect size obtained from published pilot data, we expected the change in baseline/posttreatment Behavioral Activation for the SCThrive intervention group to be n2 = .14 (large effect). Based on these assumptions, the desired sample size was 54 participants (N = 27 per group) to achieve power of .80.
Statistical Test of Hypothesis	P-Value	.09
	Comments	The threshold for statistical significance was p =.05
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	7.75
	Confidence Interval	(2-Sided) 95%; -1.27 to 19.22
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 13.14
	Estimation Comments	[Not Specified]

2. Secondary Outcome

Title	Scores on a Self-management Measure at Baseline and 6 Weeks (Post-treatment)
Description	Participants complete the Transition Readiness Assessment Questionnaire (TRAQ-5), which is a well-validated 20-item questionnaire that measures the skills needed to manage a chronic condition independently. Items are rated on a 5-point Likert scale of 1 = "No, I do not know how" to 5 = "Yes, I always do this when I need to" and divided into 5 subscales: Managing Medication, Appointment Keeping, Tracking Health Issues, Talking with Providers, and Managing Daily Activities. Overall and subscale scores are calculated by averaging the scores of answered items. Mean scores range from 1 to 5 with higher scores indicating better self-management.
Time Frame	baseline, 6 weeks (post-treatment)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	SCThrive	Attention Control
Arm/Group Description:	SCThrive Intervention for Adolescents with SCD - 6 week self-management group SCThrive Intervention for Adolescents with SCD: Chronic Disease Self-Management Program	6 weekly 15-20 minute individual phone calls on educational topics. No interventions are included in this arm.
Overall Number of Participants Analyzed	26	27
Mean (Standard Deviation); Unit of Measure: score on a scale
Baseline Scores	3.46 (.83)	3.54 (.81)
Post-Treatment Scores	3.68 (.81)	3.53 (.79)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	SCThrive, Attention Control
	Comments	We conducted separate mixed ANOVA analyses to assess for the effects of group (SCThrive/SCHealthEd), time (baseline/post-treatment), and group x time interaction for the TRAQ-5
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	.28
	Comments	The threshold for significance was p =.05
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	.15
	Confidence Interval	(2-Sided) 95%; -.19 to .66
	Parameter Dispersion	Type: Standard Error of the Mean; Value: .55
	Estimation Comments	[Not Specified]

3. Secondary Outcome

Title	Total Scores on the UNC TRxANSITION Scale at Baseline and 6 Weeks Post-Treatment
Description	Participants complete the UNC TRxANSITION Scale, an interview administered by trained independent evaluators to measure the skills of youth with chronic conditions. For this study, we administered 6 of the 10 possible subscales: Type of Chronic Health Condition, Medications, Adherence, Nutrition, Self-Management Skills, and New Health Care Providers. Each item is scored individually as either 1 (adequate knowledge/skill mastery), 0.5 (some knowledge/skill attainment), or 0 (no knowledge/skill attainment). Higher scores indicate better self-management. Subscale scores are calculated by dividing the patient's score by the total possible subscale score. Subscale scores are then combined to create a total score, ranging from 0 to 10, but since we only used 6 scales, 0 to 6. Total and subscale proportion scores were used in analyses.
Time Frame	baseline, 6 weeks (post-treatment)

Outcome Measure Data

Analysis Population Description

Data assessing transition readiness (UNC TRxANSITION Scale) were only collected from adolescents and and young adults completing SCThrive (N=16).

Arm/Group Title	SCThrive
Arm/Group Description:	SCThrive Intervention for Adolescents with SCD - 6-week self-management group
Overall Number of Participants Analyzed	16
Mean (Standard Deviation); Unit of Measure: score on a scale
Baseline Score	1.19 (.13)
Post-Treatment Score	1.15 (.11)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	SCThrive
	Comments	We conducted a paired-samples t-test to assess for the effects of time (baseline/post-treatment) for participants (n=16) in the SCThrive intervention arm for the UNC TRxANSITION Scale.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	.27
	Comments	The threshold for statistical significance was p =.05
	Method	t-test, 2 sided
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	.02
	Confidence Interval	(2-Sided) 95%; -.018 to .06
	Parameter Dispersion	Type: Standard Deviation; Value: .13
	Estimation Comments	[Not Specified]

Adverse Events

Time Frame	baseline, 6 weeks (post-treatment)
Adverse Event Reporting Description	Monthly meetings to monitor the progress of the study, the integrity of the treatment and safety monitoring, including a review of any adverse events. If adverse events, investigators followed-up and provided referral or treatment until the event subsided. Investigators were available 24 hours via pager. The PI reported any significant study-related or unanticipated adverse events to the Institutional Review Board and study sponsor based upon institutional and sponsor guidelines.
Arm/Group Title	SCThrive	Attention Control
Arm/Group Description	SCThrive Intervention for Adolescents with SCD - 6 week self-management group SCThrive Intervention for Adolescents with SCD: Chronic Disease Self-Management Program	6 weekly 15-20 minute individual phone calls on educational topics. No interventions are included in this arm.
All-Cause Mortality
	SCThrive	Attention Control
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/26 (0.00%)	0/27 (0.00%)
Serious Adverse Events
	SCThrive	Attention Control
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/26 (0.00%)	0/27 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	SCThrive	Attention Control
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/26 (0.00%)	0/27 (0.00%)

Limitations and Caveats

[Not Specified]

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: Dr. Lori Crosby
• Organization: Cincinnati Children's Hospital Medical Center
• Phone: 513-636-5380
• EMail: Lori.Crosby@cchmc.org

Publications of Results:

Crosby LE, Hood A, Kidwell K, Nwankwo C, Peugh J, Strong H, Quinn C, Britto MT. Improving self-management in adolescents with sickle cell disease. Pediatr Blood Cancer. 2020 Oct;67(10):e28492. doi: 10.1002/pbc.28492. Epub 2020 Jul 22.

Other Publications:

Crosby LE, Modi AC, Lemanek KL, Guilfoyle SM, Kalinyak KA, Mitchell MJ. Perceived barriers to clinic appointments for adolescents with sickle cell disease. J Pediatr Hematol Oncol. 2009 Aug;31(8):571-6. doi: 10.1097/MPH.0b013e3181acd889.

Crosby LE, Joffe NE, Reynolds N, Peugh JL, Manegold E, Pai AL. Psychometric Properties of the Psychosocial Assessment Tool-General in Adolescents and Young Adults With Sickle Cell Disease. J Pediatr Psychol. 2016 May;41(4):397-405. doi: 10.1093/jpepsy/jsv073. Epub 2015 Aug 13.

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.

• Responsible Party: Children's Hospital Medical Center, Cincinnati
• ClinicalTrials.gov Identifier: NCT02851615
• Other Study ID Numbers: 1R21HD084810-01A1 ( U.S. NIH Grant/Contract )
• First Submitted: July 28, 2016
• First Posted: August 1, 2016
• Results First Submitted: December 18, 2020
• Results First Posted: March 17, 2021
• Last Update Posted: March 17, 2021