iCanCope With Sickle Cell Pain
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| ClinicalTrials.gov Identifier: NCT03201874 |
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Recruitment Status :
Completed
First Posted : June 28, 2017
Last Update Posted : January 4, 2023
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Sponsor:
Seattle Children's Hospital
Collaborators:
The Hospital for Sick Children
Emory University
Connecticut Children's Medical Center
University of Mississippi Medical Center
University of Florida
Boston Medical Center
Northwestern University
Information provided by (Responsible Party):
Tonya Palermo, Seattle Children's Hospital
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Brief Summary:
The project will test a tailored web and smartphone-based application (iCanCope with SCD) to improve pain self-management and functioning in youth (aged 12-18) with sickle cell disease. The program will include goal setting, peer-based social support, and pain self-management training. The investigators will determine initial program effectiveness through a pilot three-site randomized controlled trial in 160 youth randomized to treatment compared to attention control.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Sickle Cell Disease | Behavioral: Pain self-management Behavioral: Education | Not Applicable |
Cognitive-behavioral therapies (CBT) that promote pain self-management can lead to symptom reduction, improved quality of life, and decreased healthcare use. However, most people with SCD do not receive CBT-based treatment due to barriers such as poor accessibility, limited availability of professionals, and high costs. First, the investigators plan to apply a user-centered design approach to develop and refine the iCanCope with SCD program. Second, program feasibility and initial program effectiveness will be determined through a pilot three-site randomized controlled trial. The investigators will determine study accrual and dropout rates as well as levels of patient acceptability and engagement. Preliminary effectiveness will be determined in youth receiving treatment compared to attention control on a range of physical, behavioral, and psychosocial outcomes assessed at post-treatment and 6-month follow-up. Third, moderators and mediators of treatment effect will be tested by examining whether differences in self-efficacy and patient activation predict changes in pain and functioning. These results will enable a future full-scale randomized controlled trial.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 137 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | iCanCope With Sickle Cell Disease: A Mobile Pain Management Intervention for Adolescents |
| Actual Study Start Date : | January 1, 2018 |
| Actual Primary Completion Date : | August 31, 2022 |
| Actual Study Completion Date : | August 31, 2022 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Sickle cell disease
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Education Control
In addition to standard medical care, youth in the education control group will be provided with access to a self-guided education study website, which will contain static education about SCD (no self-management skills, goal-setting, or social support content) to access over 8-weeks.
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Behavioral: Education
Education about sickle cell disease to increase disease knowledge |
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Experimental: Pain Self-Management Intervention
In addition to standard medical SCD care, youth in the pain self-management intervention group will receive the iCanCope with SCD mobile intervention including goal-setting, peer social support, and pain self-management skills over a period of 8 weeks.
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Behavioral: Pain self-management
The program is designed to enhance self-efficacy. The app will guide youth in setting structured and personalized goals aimed at improving their pain and functioning. The pain self-management skills will include personalized CBT-based coping skills including deep breathing, relaxation, and cognitive skills (e.g., staying positive). The app will provide in-the-moment access to pain coping strategies to promote positive changes in mood, behavior, and pain. Behavioral: Education Education about sickle cell disease to increase disease knowledge |
Primary Outcome Measures :
- Pain diary [ Time Frame: Change from baseline to 12 weeks and 26 weeks ]App diary using an 11-point numerical rating scale for pain intensity and Child Activity Limitations Inventory 9-items to measure activity limitations for 7 days
- Adaptive coping [ Time Frame: Change from baseline to 12 weeks and 26 weeks ]Coping Strategies Questionnaire for Sickle Cell Disease
Secondary Outcome Measures :
- Treatment acceptability [ Time Frame: 2 months after starting treatment ]Treatment Evaluation Inventory
- Physical and emotional functioning [ Time Frame: Change from baseline to 12 weeks and 26 weeks ]Patient-reported Outcomes Measurement Information System (PROMIS) Pediatric Profile: depressive symptoms, anxiety, mobility, pain interference, fatigue, peer relationships
- Patient Global Impression of Change [ Time Frame: 12 weeks and 26 weeks ]Global rating for improvement in pain and functioning
- Parent protectiveness [ Time Frame: Change from baseline to 12 weeks and 26 weeks ]Adult Responses to Children's Symptoms
- Health services utilization [ Time Frame: Change from baseline to 26 weeks ]Client Services Receipt Inventory adapted for sickle cell disease
- Parent psychological distress [ Time Frame: Change from baseline to 12 weeks and 26 weeks ]Symptom Checklist 90
- Child physical and emotional functioning [ Time Frame: Change from baseline to 12 weeks and 26 weeks ]Bath Adolescent Pain Questionnaire - Parent version assesses social functioning (score range: 0-36), physical functioning (0-36), depression (0-24), general anxiety (0-28), pain specific anxiety (0-28), family functioning (0-48) and development (0-44). A higher score indicates more impaired functioning for all subscales.
- Unwanted treatment effects [ Time Frame: 12 weeks and 26 weeks ]Self report of adverse events during treatment. The number of participants with unwanted treatment effects will be reported.
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 12 Years to 18 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- aged between 12-18 years
- diagnosed with any type of SCD
- able to speak and read English
- score at least 4 (indicating some days with pain interference over the past month) on the Sickle Cell Pain Burden Interview
- willing and able to complete online measures
Exclusion Criteria:
- significant cognitive limitations that would impair their ability to use and understand the iCanCope with SCD program, as per their healthcare provider or parent
- have previously received more than 4 sessions of outpatient psychological therapy for pain management in the 6 months prior to the time of screening.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03201874
Locations
| United States, Connecticut | |
| Connecticut Children's Medical Center | |
| Hartford, Connecticut, United States, 06106 | |
| United States, Georgia | |
| Emory University | |
| Atlanta, Georgia, United States, 30322 | |
| United States, Washington | |
| Seattle Children's Hospital | |
| Seattle, Washington, United States, 98105 | |
| Canada, Ontario | |
| The Hospital for Sick Children | |
| Toronto, Ontario, Canada | |
Sponsors and Collaborators
Seattle Children's Hospital
The Hospital for Sick Children
Emory University
Connecticut Children's Medical Center
University of Mississippi Medical Center
University of Florida
Boston Medical Center
Northwestern University
Investigators
| Principal Investigator: | Tonya M Palermo, PhD | Seattle Children's Hospital |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Tonya Palermo, Professor, Anesthesiology and Pain Medicine, Seattle Children's Hospital |
| ClinicalTrials.gov Identifier: | NCT03201874 |
| Other Study ID Numbers: |
R01HD086978 ( U.S. NIH Grant/Contract ) |
| First Posted: | June 28, 2017 Key Record Dates |
| Last Update Posted: | January 4, 2023 |
| Last Verified: | December 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
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Anemia, Sickle Cell Anemia, Hemolytic, Congenital Anemia, Hemolytic Anemia |
Hematologic Diseases Hemoglobinopathies Genetic Diseases, Inborn |