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Community Health Workers and mHealth for Sickle Cell Disease Care

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ClinicalTrials.gov Identifier: NCT03648710
Recruitment Status : Recruiting
First Posted : August 27, 2018
Last Update Posted : July 7, 2021
Sponsor:
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
First Submitted Date  ICMJE August 24, 2018
First Posted Date  ICMJE August 27, 2018
Last Update Posted Date July 7, 2021
Actual Study Start Date  ICMJE January 15, 2019
Estimated Primary Completion Date May 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 24, 2018)
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).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 17, 2018)
  • Sickle cell disease knowledge [ Time Frame: Baseline, 6months, 12 months, 18 months ]
    Measured using the Sickle Cell Disease Knowledge Questionnaire (SCDKQ). SCDKQ is a 20-item survey. All questions have answer choices of true or false.
  • Transition Readiness [ Time Frame: Baseline, 6 months, 12 months, 18 months ]
    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.
  • Social Support [ Time Frame: Baseline, 6 months, 12 months, 18 months ]
    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".
  • Coping skills [ Time Frame: Baseline, 6 months, 12 months, 18 months ]
    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".
  • Education and vocational planning [ Time Frame: Baseline, 6 months, 12 months, 18 months ]
    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.
  • Quality of care received [ Time Frame: Baseline, 6 months, 12 months, 18 months ]
    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.
  • Medical Adherence Scale [ Time Frame: Baseline, 6 months, 12 months, 18 months ]
    Medication adherence will be measured using the Medical Adherence Measure (MAM). The MAM is a 17 question multiple choice survey.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 24, 2018)
  • Sickle cell disease knowledge [ Time Frame: Baseline, 6months, 12 months, 18 months ]
    Measured using the Sickle Cell Disease Knowledge Questionnaire (SCDKQ). SCDKQ is a 20-item survey. All questions have answer choices of true or false.
  • Transition Readiness [ Time Frame: Baseline, 6 months, 12 months, 18 months ]
    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.
  • Social Support [ Time Frame: Baseline, 6 months, 12 months, 18 months ]
    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".
  • Coping skills [ Time Frame: Baseline, 6 months, 12 months, 18 months ]
    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".
  • Education and vocational planning [ Time Frame: Baseline, 6 months, 12 months, 18 months ]
    Using the 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.
  • Quality of care received [ Time Frame: Baseline, 6 months, 12 months, 18 months ]
    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.
  • Medical Adherence Scale [ Time Frame: Baseline, 6 months, 12 months, 18 months ]
    Medication adherence will be measured using the Medical Adherence Measure (MAM). The MAM is a 17 question multiple choice survey.
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:

  • 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 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
Condition  ICMJE Sickle Cell Disease
Intervention  ICMJE
  • Other: Peer Community Health Worker
    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.
  • Other: Mobile Health
    A mobile health application created as a resource for young adults transitioning.
Study Arms  ICMJE
  • No Intervention: Enhanced Usual Care
    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.
  • Experimental: Peer Community Health Worker
    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
    Intervention: Other: Peer Community Health Worker
  • Experimental: Mobile Health
    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.
    Intervention: Other: Mobile Health
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 24, 2018)
450
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 30, 2022
Estimated Primary Completion Date May 31, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 17 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Tanisha D Belton, MPH 215-590-4673 beltont@chop.edu
Contact: Caren M Steinway, MPH MSW 516-838-6421 csteinway@northwell.edu
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
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Children's Hospital of Philadelphia
Study Sponsor  ICMJE Children's Hospital of Philadelphia
Collaborators  ICMJE
  • 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
Investigators  ICMJE
Principal Investigator: David Rubin, MD Children's Hospital of Philadelphia
Principal Investigator: Sophia Jan, MD Cohen's Children Medical Center/Northwell Health
Principal Investigator: Kim Smith-Whitley, MD Children's Hospital of Philadelphia
PRS Account Children's Hospital of Philadelphia
Verification Date July 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP