SCThrive: Improving Self-Management in Adolescents With Sickle Cell Disease
Improving Self-Management in Adolescents With Sickle Cell Disease
Sponsors
Source
Children's Hospital Medical Center, Cincinnati
Oversight Info
Has Dmc
No
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.
Overall Status
Completed
Start Date
2016-03-31
Completion Date
2018-03-31
Primary Completion Date
2018-03-31
Phase
N/A
Study Type
Interventional
Primary Outcome
Measure |
Time Frame |
|
Change from baseline on behavioral activation measure at 6 weeks |
baseline, 6 weeks (post-intervention |
Enrollment
53
Condition
Intervention
Intervention Type
Behavioral
Intervention Name
Description
Chronic Disease Self-Management Program
Arm Group Label
SCThrive
Eligibility
Criteria
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.
Gender
All
Minimum Age
13 Years
Maximum Age
21 Years
Healthy Volunteers
No
Overall Official
Last Name |
Role |
Affiliation |
|
Lori E Crosby, PsyD |
Principal Investigator |
Children's Hospital Medical Center, Cincinnati |
Location
Facility |
|
Cincinnati Children's Hospital Medical Center Cincinnati Ohio 45229 United States |
Location Countries
Country
United States
Verification Date
2018-08-01
Lastchanged Date
N/A
Firstreceived Date
N/A
Responsible Party
Responsible Party Type
Sponsor
Keywords
Has Expanded Access
No
Condition Browse
Number Of Arms
2
Arm Group
Arm Group Label
SCThrive
Arm Group Type
Other
Description
SCThrive Intervention for Adolescents with SCD - 6 week self-management group
Arm Group Label
Attention Control
Arm Group Type
No Intervention
Description
6 weekly 15-20 minute individual phone calls on educational topics. No interventions are included in this arm.
Results Reference
Citation
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.
PMID
19636266
Citation
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.
PMID
26275975
Citation
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.
PMID
25414599
Firstreceived Results Date
N/A
Acronym
SCThrive
Patient Data
Sharing Ipd
No
Firstreceived Results Disposition Date
N/A
Study Design Info
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)
Study First Submitted
July 28, 2016
Study First Submitted Qc
July 28, 2016
Study First Posted
August 1, 2016
Last Update Submitted
August 6, 2018
Last Update Submitted Qc
August 6, 2018
Last Update Posted
August 7, 2018
ClinicalTrials.gov processed this data on August 31, 2018
Conditions
Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov,
conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions
Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied.
Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase
Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions
that study is seeking to answer:
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.