Sickle Cell Disease
Conditions
Keywords
Anemia, Sickle Cell, Self Care, Adolescent, Young Adult, Disease Management, Behavioral Activation, Peer Communication
Brief summary
The objective of this study is to determine the feasibility and acceptability of SCThrive, a an innovative, technology-enhanced, group self-management intervention that uses a mixed in-person and online format and supported by a tailored mHealth tool, iManage. The study will also evaluate the initial efficacy of SCThrive for increasing behavioral activation (BA) in adolescents with Sickle Cell Disease (SCD) ages 13 to 21. The investigators hypothesize that participants in the SCThrive group will show greater BA (primary outcome) at post-treatment than the attention control group, and that participants in the SCThrive group will continue to show significantly greater BA at the six week follow-up compared to the attention control group. Investigators will also explore whether SCThrive is associated with greater improvements in self-management behaviors and quality of life (secondary outcome) compared to attention control at the six-week follow-up assessment.
Detailed description
The objective of this study is to determine the feasibility and acceptability of SCThrive, a an innovative, technology-enhanced, group self-management intervention that uses a mixed in-person and online format and supported by a tailored mHealth tool, iManage. The study will also evaluate the initial efficacy of SCThrive for increasing behavioral activation (BA) in adolescents with Sickle Cell Disease (SCD) ages 13 to 21.
Interventions
BEHAVIORALSCThrive Intervention for Adolescents with SCD
Chronic Disease Self-Management Program
Sponsors
Children's Hospital Medical Center, Cincinnati
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
13 Years to 21 Years
Healthy volunteers
No
Inclusion criteria
* Patient of CCHMC Sickle Cell Clinic. * Confirmed diagnosis of SCD with SS, SB0Thal or SC genotype. * 13-21 years of age. * On or eligible for disease-modifying therapies. * Caregiver (or AYA \> 18 years) consent that the participant will be the sole user of the tablet, report immediately if it is damaged or lost, return it at the end of the study, and log on to sessions from a private location.
Exclusion criteria
* another chronic disease (which would complicate measurement of behavioral activation) * Non-English-speaking (\<5% of the target population); or * cognitive or psychiatric disorder that the physician or study therapists believe would impair study participation. Patients who desire participation but are not eligible will be referred to the SCD Clinic social worker for assistance with self-management as this is the usual procedure.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Scores on Behavioral Activation Measure at Baseline and 6 Weeks (Post-treatment) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Scores on a Self-management Measure at Baseline and 6 Weeks (Post-treatment) | 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. |
| Total Scores on the UNC TRxANSITION Scale at Baseline and 6 Weeks Post-Treatment | baseline, 6 weeks (post-treatment) | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| SCThrive SCThrive Intervention for Adolescents with SCD - 6 week self-management group
SCThrive Intervention for Adolescents with SCD: Chronic Disease Self-Management Program | 27 |
| Attention Control 6 weekly 15-20 minute individual phone calls on educational topics. No interventions are included in this arm. | 31 |
| Total | 58 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Cognitive Issue | 1 | 0 |
| Overall Study | Lost to Follow-up | 0 | 4 |
Baseline characteristics
| Characteristic | SCThrive | Total | Attention Control |
|---|---|---|---|
| Age, Continuous | 16.7 years STANDARD_DEVIATION 2.3 | 16.5 years STANDARD_DEVIATION 2.4 | 16.3 years STANDARD_DEVIATION 2.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 26 Participants | 53 Participants | 27 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 26 Participants | 53 Participants | 27 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 27 Participants | 58 Participants | 31 Participants |
| Sex: Female, Male Female | 14 Participants | 28 Participants | 14 Participants |
| Sex: Female, Male Male | 12 Participants | 25 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 26 | 0 / 27 |
| other Total, other adverse events | 0 / 26 | 0 / 27 |
| serious Total, serious adverse events | 0 / 26 | 0 / 27 |
Outcome results
Primary
Scores on Behavioral Activation Measure at Baseline and 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.
Time frame: baseline, 6 weeks (post-treatment)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SCThrive | Scores on Behavioral Activation Measure at Baseline and 6 Weeks (Post-treatment) | Baseline Scores | 68.48 score on a scale | Standard Deviation 15.47 |
| SCThrive | 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 |
| Attention Control | Scores on Behavioral Activation Measure at Baseline and 6 Weeks (Post-treatment) | Baseline Scores | 69.13 score on a scale | Standard Deviation 20.75 |
| Attention Control | Scores on Behavioral Activation Measure at Baseline and 6 Weeks (Post-treatment) | Post- Treatment Scores | 68.82 score on a scale | Standard Deviation 18.18 |
Comparison: 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.p-value: 0.0995% CI: [-1.27, 19.22]ANCOVA
Secondary
Scores on a Self-management Measure at Baseline and 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.
Time frame: baseline, 6 weeks (post-treatment)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SCThrive | Scores on a Self-management Measure at Baseline and 6 Weeks (Post-treatment) | Baseline Scores | 3.46 score on a scale | Standard Deviation 0.83 |
| SCThrive | Scores on a Self-management Measure at Baseline and 6 Weeks (Post-treatment) | Post-Treatment Scores | 3.68 score on a scale | Standard Deviation 0.81 |
| Attention Control | Scores on a Self-management Measure at Baseline and 6 Weeks (Post-treatment) | Baseline Scores | 3.54 score on a scale | Standard Deviation 0.81 |
| Attention Control | Scores on a Self-management Measure at Baseline and 6 Weeks (Post-treatment) | Post-Treatment Scores | 3.53 score on a scale | Standard Deviation 0.79 |
Comparison: 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-5p-value: 0.2895% CI: [-0.19, 0.66]ANCOVA
Secondary
Total Scores on the UNC TRxANSITION Scale at Baseline and 6 Weeks Post-Treatment
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)
Population: Data assessing transition readiness (UNC TRxANSITION Scale) were only collected from adolescents and and young adults completing SCThrive (N=16).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SCThrive | Total Scores on the UNC TRxANSITION Scale at Baseline and 6 Weeks Post-Treatment | Baseline Score | 1.19 score on a scale | Standard Deviation 0.13 |
| SCThrive | 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 0.11 |
Comparison: 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.p-value: 0.2795% CI: [-0.018, 0.06]t-test, 2 sided