Trial Outcomes & Findings for Improving Self-Management in Adolescents With Sickle Cell Disease (NCT NCT02851615)
NCT ID: NCT02851615
Last Updated: 2024-03-04
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
66 participants
Primary outcome timeframe
baseline, 6 weeks (post-treatment)
Results posted on
2024-03-04
Participant Flow
Participant milestones
| Measure |
SCThrive
SCThrive Intervention for Adolescents with SCD - 6 week self-management group
SCThrive Intervention for Adolescents with SCD: Chronic Disease Self-Management Program
|
Attention Control
6 weekly 15-20 minute individual phone calls on educational topics. No interventions are included in this arm.
|
|---|---|---|
|
Overall Study
STARTED
|
27
|
31
|
|
Overall Study
COMPLETED
|
26
|
27
|
|
Overall Study
NOT COMPLETED
|
1
|
4
|
Reasons for withdrawal
| Measure |
SCThrive
SCThrive Intervention for Adolescents with SCD - 6 week self-management group
SCThrive Intervention for Adolescents with SCD: Chronic Disease Self-Management Program
|
Attention Control
6 weekly 15-20 minute individual phone calls on educational topics. No interventions are included in this arm.
|
|---|---|---|
|
Overall Study
Cognitive Issue
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
4
|
Baseline Characteristics
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).
Baseline characteristics by cohort
| Measure |
SCThrive
n=27 Participants
SCThrive Intervention for Adolescents with SCD - 6 week self-management group
SCThrive Intervention for Adolescents with SCD: Chronic Disease Self-Management Program
|
Attention Control
n=31 Participants
6 weekly 15-20 minute individual phone calls on educational topics. No interventions are included in this arm.
|
Total
n=58 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
16.7 years
STANDARD_DEVIATION 2.3 • n=26 Participants • 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).
|
16.3 years
STANDARD_DEVIATION 2.5 • n=27 Participants • 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).
|
16.5 years
STANDARD_DEVIATION 2.4 • n=53 Participants • 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
Female
|
14 Participants
n=26 Participants • 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).
|
14 Participants
n=27 Participants • 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).
|
28 Participants
n=53 Participants • 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
Male
|
12 Participants
n=26 Participants • 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).
|
13 Participants
n=27 Participants • 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).
|
25 Participants
n=53 Participants • 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)
Hispanic or Latino
|
0 Participants
n=26 Participants • 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).
|
0 Participants
n=27 Participants • 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).
|
0 Participants
n=53 Participants • 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)
Not Hispanic or Latino
|
26 Participants
n=26 Participants • 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).
|
27 Participants
n=27 Participants • 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).
|
53 Participants
n=53 Participants • 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)
Unknown or Not Reported
|
0 Participants
n=26 Participants • 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).
|
0 Participants
n=27 Participants • 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).
|
0 Participants
n=53 Participants • 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)
American Indian or Alaska Native
|
0 Participants
n=26 Participants • 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).
|
0 Participants
n=27 Participants • 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).
|
0 Participants
n=53 Participants • 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)
Asian
|
0 Participants
n=26 Participants • 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).
|
0 Participants
n=27 Participants • 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).
|
0 Participants
n=53 Participants • 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)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=26 Participants • 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).
|
0 Participants
n=27 Participants • 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).
|
0 Participants
n=53 Participants • 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)
Black or African American
|
26 Participants
n=26 Participants • 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).
|
27 Participants
n=27 Participants • 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).
|
53 Participants
n=53 Participants • 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)
White
|
0 Participants
n=26 Participants • 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).
|
0 Participants
n=27 Participants • 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).
|
0 Participants
n=53 Participants • 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)
More than one race
|
0 Participants
n=26 Participants • 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).
|
0 Participants
n=27 Participants • 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).
|
0 Participants
n=53 Participants • 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)
Unknown or Not Reported
|
0 Participants
n=26 Participants • 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).
|
0 Participants
n=27 Participants • 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).
|
0 Participants
n=53 Participants • 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
United States
|
27 Participants
n=27 Participants
|
31 Participants
n=31 Participants
|
58 Participants
n=58 Participants
|
PRIMARY outcome
Timeframe: baseline, 6 weeks (post-treatment)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.
Outcome measures
| Measure |
SCThrive
n=26 Participants
SCThrive Intervention for Adolescents with SCD - 6 week self-management group
SCThrive Intervention for Adolescents with SCD: Chronic Disease Self-Management Program
|
Attention Control
n=27 Participants
6 weekly 15-20 minute individual phone calls on educational topics. No interventions are included in this arm.
|
|---|---|---|
|
Scores on Behavioral Activation Measure at Baseline and 6 Weeks (Post-treatment)
Baseline Scores
|
68.48 score on a scale
Standard Deviation 15.47
|
69.13 score on a scale
Standard Deviation 20.75
|
|
Scores on Behavioral Activation Measure at Baseline and 6 Weeks (Post-treatment)
Post- Treatment Scores
|
76.57 score on a scale
Standard Deviation 15.04
|
68.82 score on a scale
Standard Deviation 18.18
|
SECONDARY outcome
Timeframe: baseline, 6 weeks (post-treatment)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.
Outcome measures
| Measure |
SCThrive
n=26 Participants
SCThrive Intervention for Adolescents with SCD - 6 week self-management group
SCThrive Intervention for Adolescents with SCD: Chronic Disease Self-Management Program
|
Attention Control
n=27 Participants
6 weekly 15-20 minute individual phone calls on educational topics. No interventions are included in this arm.
|
|---|---|---|
|
Scores on a Self-management Measure at Baseline and 6 Weeks (Post-treatment)
Baseline Scores
|
3.46 score on a scale
Standard Deviation .83
|
3.54 score on a scale
Standard Deviation .81
|
|
Scores on a Self-management Measure at Baseline and 6 Weeks (Post-treatment)
Post-Treatment Scores
|
3.68 score on a scale
Standard Deviation .81
|
3.53 score on a scale
Standard Deviation .79
|
SECONDARY outcome
Timeframe: baseline, 6 weeks (post-treatment)Population: Data assessing transition readiness (UNC TRxANSITION Scale) were only collected from adolescents and and young adults completing SCThrive (N=16).
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.
Outcome measures
| Measure |
SCThrive
n=16 Participants
SCThrive Intervention for Adolescents with SCD - 6 week self-management group
SCThrive Intervention for Adolescents with SCD: Chronic Disease Self-Management Program
|
Attention Control
6 weekly 15-20 minute individual phone calls on educational topics. No interventions are included in this arm.
|
|---|---|---|
|
Total Scores on the UNC TRxANSITION Scale at Baseline and 6 Weeks Post-Treatment
Baseline Score
|
1.19 score on a scale
Standard Deviation .13
|
—
|
|
Total Scores on the UNC TRxANSITION Scale at Baseline and 6 Weeks Post-Treatment
Post-Treatment Score
|
1.15 score on a scale
Standard Deviation .11
|
—
|
Adverse Events
SCThrive
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Attention Control
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
Dr. Lori Crosby
Cincinnati Children's Hospital Medical Center
Phone: 513-636-5380
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place