Sickle Cell DiseaseNCT03648710
Community Health Workers and mHealth for Sickle Cell Disease Care
A study testing Peer Community Health Worker and Mobile Health in people with Sickle Cell Disease, run by Children's Hospital of Philadelphia at 5 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 17 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sickle Cell Disease
- What is being tested?
- Peer Community Health Worker and Mobile Health
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 405 participants
- Where
- 5 sitesUnited States
- Study dates
- 15 Jan 2019to 31 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 17 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Males or females age 17 years or older
- Have sickle cell disease, defined as those individuals with HbSS, HbSC, HbSβ0Thal, HbSβ+Thal genotypes
- Receive care at a participating pediatric sickle cell disease center.
- Appropriate for transfer to an adult hematologist within 12 months
Who cannot join
- 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). Individuals without access to a mobile device, tablet or computer.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Connecticut Children's Medical Center
Hartford, Connecticut, 06106
Cohen's Children's Medical Center
New Hyde Park, New York, 11040
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
St. Christophers Hospital for Children
Philadelphia, Pennsylvania, 19134
About this study
Official title: Community Health Workers and Mobile Health for Emerging Adults Transitioning Sickle Cell Disease Care
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.
Read the 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:
- Identify and quantify whether patient activation, self-management behaviors, biologic markers, and transfer to adult care are mediators of intervention treatment effects.
- Identify individual and family factors that moderate intervention treatment effects
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).
- Conditions
- Sickle Cell Disease
- Being tested
- Peer Community Health Worker, Mobile Health
- Keywords
- Sickle Cell Disease
- 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.
Peer Community Health WorkerOther
Participants will be communicating with their CHWs on a weekly basis, which is consistent with other successful community health worker protocols with published efficacy. Community Health Workers will be peers with sickle cell disease, who have successfully transitioned and are under 30 years of age.
Mobile HealthOther
A mobile health application created as a resource for young adults transitioning.
| Study group | Role | What they receive |
|---|---|---|
| Enhanced Usual Care | No intervention | Enhanced usual care will be standardized across sites with transition/transfer of care checklists that will be used at all sites. Enhanced usual care will minimally include (1) patient seen by the pediatric provider with the parent outside the examination room, (2) a social work consult to screen and address sociodemographic risk factors, (3) information on health insurance adequacy provided to patient, (4) adult hematologist identified, (5) adult primary care provider identified, (6) medical release signed, and (7) medical record viewable or sent to adult provider. |
| Peer Community Health Worker | Experimental | The CHW program will primarily be modeled after the highly successful IMPaCT Program developed by the Penn Center for Community Health Workers and CHOP's Youth CHW Program for Pediatric to Adult Transitions developed by our research team, which were both developed with high levels of patient input. SCD specific content and expertise from the CHW Program through the Sickle Cell Disease Association of American Philadelphia Delaware Valley Chapter and other published models will be included. Components will include: 1) development of patient-centered goals and individualized action plan around self-care, symptom tracking, and transition to adult care; 2) provision of information, skills, and tips; and 3) tailored peer support using telephone calls and/or visits Receives: Other: Peer Community Health Worker |
| Mobile Health | Experimental | All participants enrolled in the mHealth arm will download an enhanced version of iManage, which was developed by Co-Investigator Lori Crosby at and adolescents and young adult patients with SCD. Components include: 1) development of patient-centered goals around self-care, symptom tracking, and transition to adult care; 2) provision of information, skills, and tips; 3) virtual peer support where users can encourage others to complete goals, forms teams, and interact with other youth with SCD; and 4) daily symptom tracking and visual tracking of goal completion. Investigators will add with daily tailored texting. Receives: Other: Mobile Health |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Health-Related Quality of Life (HRQOL)
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).
Measured: Baseline, 6 months, 12months, and 18 months.
Secondary outcomes (7)
Sickle cell disease knowledge
Measured using the Sickle Cell Disease Knowledge Questionnaire (SCDKQ). SCDKQ is a 20-item survey. All questions have answer choices of true or false.
Measured: Baseline, 6months, 12 months, 18 months
Transition Readiness
Measured using the Transition Readiness Assessment Questionnaire (TRAQ). TRAQ is a 20 item survey of transition readiness. Answer choices are based on stages of change and are on a 5-point scale.
Measured: Baseline, 6 months, 12 months, 18 months
Social Support
Measured using the Medical Outcomes Study Social Support Survey (MOS-SSS). The MOS-SSS is a 19-item survey. Answer choices are on a 5-point Likert scale ranging from "none of the time" to "all of the time".
Measured: Baseline, 6 months, 12 months, 18 months
Coping skills
Coping strategies using the Coping Strategies Questionnaire (Brief COPE). The Brief COPE is a 28-item survey with answer choices on a 4-point Likert scale, ranging from "I haven't been doing this at all" to "I've been doing this a lot".
Measured: Baseline, 6 months, 12 months, 18 months
Education and vocational planning
Using the Transition Intervention Program - Readiness for Transition (TIPS-RFT) sub scale to measure education and vocational planning. The educational and vocational planning subscale of the TIPS-RFT is a 4 question subscale.
Measured: Baseline, 6 months, 12 months, 18 months
Quality of care received
Using the Adult Sickle Cell Quality of Life Measurement Information System (ASCQ-Me) measure. The quality of care received subscale is from the ASCQ-Me. The subscale is 27 multiple choice questions.
Measured: Baseline, 6 months, 12 months, 18 months
Medical Adherence Scale
Medication adherence will be measured using the Medical Adherence Measure (MAM). The MAM is a 17 question multiple choice survey.
Measured: Baseline, 6 months, 12 months, 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2018
- Study start15 Jan 2019
- Primary completion31 Aug 2024
- Study completion31 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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 of PhiladelphiaThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 405 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Collaborators
- St. Christopher's Hospital for Children, Children's Hospital Medical Center, Cincinnati, Steven and Alexandra Cohen Children's Medical Center, Connecticut Children's Medical Center, Patient-Centered Outcomes Research Institute
- Responsible party
- Sponsor
- Investigators
- David Rubin, MD, Principal investigator, Children's Hospital of PhiladelphiaSophia Jan, MD, Principal investigator, Cohen's Children Medical Center/Northwell HealthKim Smith-Whitley, MD, Principal investigator, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03648710
- Sponsor's protocol ID
- 18-015106
- Status last verified
- Dec 2024
- First submitted
- 24 Aug 2018
- Last updated
- 4 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Jan S, Steinway C, Belton T, Shults J, Bennett L, Teng O, Griffis H, Aygun B, Appiah-Kubi A, Apollonsky N, Boruchov D, Niss O, Schwartz L, Crosby L, Barakat L, Andemariam B, Mulchan SS, Rubin D, Smith-Whitley K. Community Health Worker and Mobile Health Interventions for Quality of Life Among Young Adults With Sickle Cell Disease: A Randomized Clinical Trial. JAMA Netw Open. 2025 Nov 3;8(11):e2543571. doi: 10.1001/jamanetworkopen.2025.43571.
PubMed 41247734Belton TD, Steinway CM, Teng O, Shults J, Barakat LP, Aygun B, Appiah-Kubi A, Crosby LE, Niss O, Andemariam B, Schwartz LA, Luma S, Smith KA, Johnson TB, Rubin DM, Smith-Whitley KM, Jan S. The Community Health Workers and Mobile Health for Emerging Adults Transitioning Sickle Cell Disease Care (COMETS) Trial: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2025 Sep 4;14:e69239. doi: 10.2196/69239.
PubMed 40905609Lalji R, Koh L, Francis A, Khalid R, Guha C, Johnson DW, Wong G. Patient navigator programmes for children and adolescents with chronic diseases. Cochrane Database Syst Rev. 2024 Oct 9;10(10):CD014688. doi: 10.1002/14651858.CD014688.pub2.
PubMed 39382077
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community Health Workers and Mobile Health for Emerging Adults Transitioning Sickle Cell Disease Care
- ClinicalTrials.gov ID
- NCT03648710
- Acronym / sponsor ID
- 18-015106
- Conditions
- Sickle Cell Disease
- Keywords
- Sickle Cell Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 405 participants (actual)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Collaborators
- St. Christopher's Hospital for Children, Children's Hospital Medical Center, Cincinnati, Steven and Alexandra Cohen Children's Medical Center, Connecticut Children's Medical Center, Patient-Centered Outcomes Research Institute
- Study start
- 15 Jan 2019 (actual)
- Primary completion
- 31 Aug 2024 (actual)
- Study completion
- 31 Aug 2024 (actual)
- First posted
- 27 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Identify and quantify whether patient activation, self-management behaviors, biologic markers, and transfer to adult care are mediators of intervention treatment effects.
- Identify individual and family factors that moderate intervention treatment effects
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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Enhanced Usual Care | No intervention | –Enhanced usual care will be standardized across sites with transition/transfer of care checklists that will be used at all sites. Enhanced usual care will minimally include (1) patient seen by the pediatric provider with the parent outside the examination room, (2) a social work consult to screen and address sociodemographic risk factors, (3) information on health insurance adequacy provided to patient, (4) adult hematologist identified, (5) adult primary care provider identified, (6) medical release signed, and (7) medical record viewable or sent to adult provider. |
| Peer Community Health Worker | Experimental | Other: Peer Community Health WorkerThe CHW program will primarily be modeled after the highly successful IMPaCT Program developed by the Penn Center for Community Health Workers and CHOP's Youth CHW Program for Pediatric to Adult Transitions developed by our research team, which were both developed with high levels of patient input. SCD specific content and expertise from the CHW Program through the Sickle Cell Disease Association of American Philadelphia Delaware Valley Chapter and other published models will be included. Components will include: 1) development of patient-centered goals and individualized action plan around self-care, symptom tracking, and transition to adult care; 2) provision of information, skills, and tips; and 3) tailored peer support using telephone calls and/or visits |
| Mobile Health | Experimental | Other: Mobile HealthAll participants enrolled in the mHealth arm will download an enhanced version of iManage, which was developed by Co-Investigator Lori Crosby at and adolescents and young adult patients with SCD. Components include: 1) development of patient-centered goals around self-care, symptom tracking, and transition to adult care; 2) provision of information, skills, and tips; 3) virtual peer support where users can encourage others to complete goals, forms teams, and interact with other youth with SCD; and 4) daily symptom tracking and visual tracking of goal completion. Investigators will add with daily tailored texting. |
Who may qualify
- Ages
- 17 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Males or females age 17 years or older
- Have sickle cell disease, defined as those individuals with HbSS, HbSC, HbSβ0Thal, HbSβ+Thal genotypes
- Receive care at a participating pediatric sickle cell disease center.
- Appropriate for transfer to an adult hematologist within 12 months
Key exclusion criteria (1 listed)
- 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). Individuals without access to a mobile device, tablet or computer.
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 |
|---|---|---|
| Peer Community Health WorkerParticipants will be communicating with their CHWs on a weekly basis, which is consistent with other successful community health worker protocols with published efficacy. Community Health Workers will be peers with sickle cell disease, who have successfully transitioned and are under 30 years of age. | Other | Peer Community Health Worker |
| Mobile HealthA mobile health application created as a resource for young adults transitioning. | Other | Mobile Health |
Primary outcome
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).
7 secondary outcomes
Sickle cell disease knowledge
Time frame: Baseline, 6months, 12 months, 18 months
Transition Readiness
Time frame: Baseline, 6 months, 12 months, 18 months
Social Support
Time frame: Baseline, 6 months, 12 months, 18 months
Coping skills
Time frame: Baseline, 6 months, 12 months, 18 months
Education and vocational planning
Time frame: Baseline, 6 months, 12 months, 18 months
Quality of care received
Time frame: Baseline, 6 months, 12 months, 18 months
Medical Adherence Scale
Time frame: Baseline, 6 months, 12 months, 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2024.
- Derived from this study: PubMed 41247734Jan S, Steinway C, Belton T, Shults J, Bennett L, Teng O, Griffis H, Aygun B, Appiah-Kubi A, Apollonsky N, Boruchov D, Niss O, Schwartz L, Crosby L, Barakat L, Andemariam B, Mulchan SS, Rubin D, Smith-Whitley K. Community Health Worker and Mobile Health Interventions for Quality of Life Among Young Adults With Sickle Cell Disease: A Randomized Clinical Trial. JAMA Netw Open. 2025 Nov 3;8(11):e2543571. doi: 10.1001/jamanetworkopen.2025.43571.
- Derived from this study: PubMed 40905609Belton TD, Steinway CM, Teng O, Shults J, Barakat LP, Aygun B, Appiah-Kubi A, Crosby LE, Niss O, Andemariam B, Schwartz LA, Luma S, Smith KA, Johnson TB, Rubin DM, Smith-Whitley KM, Jan S. The Community Health Workers and Mobile Health for Emerging Adults Transitioning Sickle Cell Disease Care (COMETS) Trial: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2025 Sep 4;14:e69239. doi: 10.2196/69239.
- Derived from this study: PubMed 39382077Lalji R, Koh L, Francis A, Khalid R, Guha C, Johnson DW, Wong G. Patient navigator programmes for children and adolescents with chronic diseases. Cochrane Database Syst Rev. 2024 Oct 9;10(10):CD014688. doi: 10.1002/14651858.CD014688.pub2.
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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.
David Rubin, MD principal investigator
Children's Hospital of Philadelphia
Sophia Jan, MD principal investigator
Cohen's Children Medical Center/Northwell Health
Kim Smith-Whitley, MD principal investigator
Children's Hospital of Philadelphia
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peer Community Health Worker and Mobile Health in people with Sickle Cell Disease, run by Children's Hospital of Philadelphia at 5 sites 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 4 inclusion and 1 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 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in Health-Related Quality of Life (HRQOL) (time frame: Baseline, 6 months, 12months, and 18 months.). 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 NCT03648710, which also lists 3 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 Dec 2024.