Community Health Workers and mHealth for Sickle Cell Disease Care
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT03648710 |
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Recruitment Status :
Active, not recruiting
First Posted : August 27, 2018
Last Update Posted : February 9, 2023
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Sponsor:
Children's Hospital of Philadelphia
Collaborators:
St. Christopher's Hospital for Children
Children's Hospital Medical Center, Cincinnati
Steven and Alexandra Cohen Children's Medical Center of Northwell Health
Connecticut Children's Medical Center
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
Children's Hospital of Philadelphia
| Tracking Information | ||||||||||
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| First Submitted Date ICMJE | August 24, 2018 | |||||||||
| First Posted Date ICMJE | August 27, 2018 | |||||||||
| Last Update Posted Date | February 9, 2023 | |||||||||
| Actual Study Start Date ICMJE | January 15, 2019 | |||||||||
| Estimated Primary Completion Date | August 31, 2024 (Final data collection date for primary outcome measure) | |||||||||
| Current Primary Outcome Measures ICMJE |
Change in Health-Related Quality of Life (HRQOL) [ Time Frame: Baseline, 6 months, 12months, and 18 months. ] Health-Related Quality of life will be assessed with the PedsQL Sickle Cell Disease (SCD) Module. The PedsQL Sickle Cell Disease Module is a well-validated for use in adolescents and young adults with chronic disease and use a Likert response scale, with higher scores indicating better HRQOL and lower SCD symptoms and problems. The PedsQL SCD Module is a 43-item that measures nine scales: Pain and Hurt (9 items), Pain Impact (10 items), Pain Management and Control (2 items), Worry I (5 items), Worry II (2 items), Emotions (2 items), Treatment (7 items), Communication I (3 items), and Communication II (3 items).
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| Original Primary Outcome Measures ICMJE | Same as current | |||||||||
| Change History | ||||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Pre-specified Outcome Measures | Not Provided | |||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | |||||||||
| Descriptive Information | ||||||||||
| Brief Title ICMJE | Community Health Workers and mHealth for Sickle Cell Disease Care | |||||||||
| Official Title ICMJE | Community Health Workers and Mobile Health for Emerging Adults Transitioning Sickle Cell Disease Care | |||||||||
| Brief Summary | This study will compare the effectiveness of two self-management support interventions-Community Health Workers (CHW) and mobile health (mHealth)-versus enhanced usual care to improve health-related quality of life and acute care use for transitioning youth with sickle cell disease (SCD), and identify and quantify mediators and moderators of intervention treatment effects. | |||||||||
| Detailed Description | Emerging adults with sickle cell disease (SCD) experience a seven-fold increase in mortality rates during the transition period (16-25 years of age). This staggering increase in mortality and acute care utilization during this vulnerable period is partly due to difficulty coordinating care during the transition to adult care. Critical psychosocial issues further compound the vulnerability of emerging adults with SCD during the transition from pediatric to adult care9. Unfortunately, none of these transition intervention studies included adolescents or young adults with SCD. Patients, parents, and providers of those with SCD agree that the ability to independently perform chronic disease self-management is critical to staying healthy during this turbulent transition period. Self-management support is a key component of the Chronic Care Model. Community health worker (CHW) programs are increasingly popular and have efficacy on chronic disease self-management and system navigation. Mobile health platforms are equally popular, and have efficacy on self-management and adherence. Unfortunately, the effectiveness of mHealth and tailored texting among emerging adults with SCD is still unknown. Furthermore, also unknown is the comparative effectiveness of CHW programs and mHealth. The purpose of the study is to determine the comparative effectiveness of CHW programs and mHealth among emerging adults with SCD during transition versus enhanced usual care to improve health-related quality of life and acute care use for transitioning youth with SCD. The primary objective of this study is to compare the effectiveness of two self-management support interventions (community health workers and mobile health) versus enhanced usual care to improve health-related quality of life and acute care use for transitioning youth with SCD. The secondary objectives are to:
The exploratory aim is to: •Explore the association of enhancements to usual care on pediatric and adult acute utilization The study population will consist of all patients with SCD who are 17 or older and are appropriate for transfer to an adult hematologist within 12 months. Excluded are individuals with an intellectual disability that is severe enough that the individual would not have the capacity to interact with a mobile or web-based program even with assistance or have a conversation with a community health worker (i.e. non-verbal). |
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| Study Type ICMJE | Interventional | |||||||||
| Study Phase ICMJE | Not Applicable | |||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Care Provider, Investigator) Primary Purpose: Supportive Care |
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| Condition ICMJE | Sickle Cell Disease | |||||||||
| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | |||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | ||||||||||
| Recruitment Status ICMJE | Active, not recruiting | |||||||||
| Estimated Enrollment ICMJE |
450 | |||||||||
| Original Estimated Enrollment ICMJE | Same as current | |||||||||
| Estimated Study Completion Date ICMJE | August 31, 2024 | |||||||||
| Estimated Primary Completion Date | August 31, 2024 (Final data collection date for primary outcome measure) | |||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 17 Years and older (Child, Adult, Older Adult) | |||||||||
| Accepts Healthy Volunteers ICMJE | Yes | |||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||||||||
| Listed Location Countries ICMJE | United States | |||||||||
| Removed Location Countries | ||||||||||
| Administrative Information | ||||||||||
| NCT Number ICMJE | NCT03648710 | |||||||||
| Other Study ID Numbers ICMJE | 18-015106 | |||||||||
| Has Data Monitoring Committee | No | |||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE | Not Provided | |||||||||
| Current Responsible Party | Children's Hospital of Philadelphia | |||||||||
| Original Responsible Party | Same as current | |||||||||
| Current Study Sponsor ICMJE | Children's Hospital of Philadelphia | |||||||||
| Original Study Sponsor ICMJE | Same as current | |||||||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| PRS Account | Children's Hospital of Philadelphia | |||||||||
| Verification Date | February 2023 | |||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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