Sickle Cell DiseaseSCThriveNCT02851615
Improving Self-Management in Adolescents With Sickle Cell Disease
A study testing SCThrive Intervention for Adolescents with SCD in people with Sickle Cell Disease, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 21 years
- Conditions the study is for
- Sickle Cell Disease
- What is being tested?
- SCThrive Intervention for Adolescents with SCD
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Mar 2016to 31 Mar 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
About this study
Official title: SCThrive: Improving Self-Management in Adolescents With Sickle Cell Disease
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.
Read the 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.
- Conditions
- Sickle Cell Disease
- Being tested
- SCThrive Intervention for Adolescents with SCD
- Keywords
- Anemia, Sickle Cell, Self Care, Adolescent, Young Adult, Disease Management, Behavioral Activation, Peer Communication
- Medical subject headings
- Anemia, Sickle Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SCThrive Intervention for Adolescents with SCDBehavioural
Chronic Disease Self-Management Program
| Study group | Role | What they receive |
|---|---|---|
| SCThrive | Other | SCThrive Intervention for Adolescents with SCD - 6 week self-management group Receives: Behavioral: SCThrive Intervention for Adolescents with SCD |
| Attention Control | No intervention | 6 weekly 15-20 minute individual phone calls on educational topics. No interventions are included in this arm. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline, 6 weeks (post-treatment)
Secondary outcomes (2)
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.
Measured: baseline, 6 weeks (post-treatment)
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.
Measured: baseline, 6 weeks (post-treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2016 (estimated)
- Study start31 Mar 2016
- Primary completion31 Mar 2018
- Study completion31 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Sickle Cell DiseaseStudies of the same condition, open and under way.
- More trials run by Children's Hospital Medical Center, CincinnatiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lori E Crosby, PsyD, Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02851615
- Sponsor's protocol ID
- 1R21HD084810-01A1
- Acronym
- SCThrive
- Status last verified
- Feb 2024
- First submitted
- 28 Jul 2016
- Last updated
- 4 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
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.
PubMed 19636266Crosby 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.
PubMed 26275975Crosby 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.
PubMed 25414599Crosby 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.
PubMed 32697889
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SCThrive: Improving Self-Management in Adolescents With Sickle Cell Disease
- ClinicalTrials.gov ID
- NCT02851615
- Acronym / sponsor ID
- SCThrive / 1R21HD084810-01A1
- Conditions
- Sickle Cell Disease
- Keywords
- Anemia, Sickle Cell, Self Care, Adolescent, Young Adult, Disease Management, Behavioral Activation, Peer Communication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Study start
- 31 Mar 2016 (actual)
- Primary completion
- 31 Mar 2018 (actual)
- Study completion
- 31 Mar 2018 (actual)
- First posted
- 1 Aug 2016 (estimated)
- Results
- Posted 17 Mar 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SCThrive | Other | Behavioral: SCThrive Intervention for Adolescents with SCDSCThrive Intervention for Adolescents with SCD - 6 week self-management group |
| Attention Control | No intervention | –6 weekly 15-20 minute individual phone calls on educational topics. No interventions are included in this arm. |
Who may qualify
- Ages
- 13 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SCThrive Intervention for Adolescents with SCDChronic Disease Self-Management Program | Behavioural | SCThrive |
Primary outcome
Scores on Behavioral Activation Measure at Baseline and 6 Weeks (Post-treatment)
Time frame: 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.
2 secondary outcomes
Scores on a Self-management Measure at Baseline and 6 Weeks (Post-treatment)
Time frame: baseline, 6 weeks (post-treatment)
Total Scores on the UNC TRxANSITION Scale at Baseline and 6 Weeks Post-Treatment
Time frame: baseline, 6 weeks (post-treatment)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 19636266Crosby 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.
- Background: PubMed 26275975Crosby 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.
- Background: PubMed 25414599Crosby 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.
- Results publication: PubMed 32697889Crosby 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lori E Crosby, PsyD principal investigator
Children's Hospital Medical Center, Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SCThrive Intervention for Adolescents with SCD in people with Sickle Cell Disease, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Mar 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Scores on Behavioral Activation Measure at Baseline and 6 Weeks (Post-treatment) (time frame: baseline, 6 weeks (post-treatment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02851615, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2024.