iCanCope With Sickle Cell Pain

Not Applicable

Completed

Conditions: Sickle Cell Disease

Interventions: Behavioral: Pain self-management
Behavioral: Education

Registration Number: NCT03201874

Lead Sponsor: Seattle Children's Hospital

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.

Detailed Description: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 137

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pain Self-Management Intervention	Pain self-management	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.
Pain Self-Management Intervention	Education	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.
Education Control	Education	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.

Primary Outcome Measures

Name	Time	Method
Pain Diary - Average Daily Activity Limitations	Baseline,12 weeks, and 26 weeks	App diary using Child Activity Limitations Inventory 9-items to measure activity limitations for 7 days Scores range from 0-100 where higher scores mean a worse outcome
Pain Diary - Average Daily Pain	Baseline,12 weeks, and 26 weeks	App diary using an 11-point numerical rating scale for pain intensity for 7 days Scores range from 0-10 where higher scores indicate a worse outcome
Adaptive Coping - Coping Attempts	Baseline,12 weeks, and 26 weeks	Coping Strategies Questionnaire for Sickle Cell Disease - Coping Attempts Factor Scores range from 0 - 180, higher scores mean a better outcome

Secondary Outcome Measures

Name	Time	Method
Child Physical and Emotional Functioning - Parent Report, Physical Functioning	Baseline,12 weeks, and 26 weeks	Bath Adolescent Pain Questionnaire - Parent version Physical Functioning (0-36). A higher score indicates more impaired functioning for all subscales.
Physical and Emotional Functioning - Fatigue	Baseline,12 weeks, and 26 weeks	Patient-reported Outcomes Measurement Information System (PROMIS) Pediatric Profile v2.0 - Fatigue T-score, higher scores means higher levels of fatigue. 50 indicates the population mean with a standard deviation of 10. A T-score of 60 is indicative of sub-clinical or elevated levels of fatigue.
Child Physical and Emotional Functioning - Parent Report, General Anxiety	Baseline,12 weeks, and 26 weeks	Bath Adolescent Pain Questionnaire - Parent version, General Anxiety (0-28). A higher score indicates more impaired functioning for all subscales.
Child Physical and Emotional Functioning - Parent Report, Development	Baseline,12 weeks, and 26 weeks	Bath Adolescent Pain Questionnaire - Parent version, Development (0-44). A higher score indicates more impaired functioning for all subscales.
Physical and Emotional Functioning - Mobility	Baseline,12 weeks, and 26 weeks	Patient-reported Outcomes Measurement Information System (PROMIS) Pediatric Profile v2.0 - Mobility T-score, higher scores means better mobility. 50 indicates the population mean with a standard deviation of 10. A T-score of 40 is indicative of sub-clinical mobility limitations.
Patient Global Impression of Change	12 weeks and 26 weeks	Global rating for improvement in pain and functioning Scores range from 1-7 where higher scores mean a better outcome
Parent Psychological Distress	Baseline,12 weeks, and 26 weeks	Symptom Checklist 90 - Global Severity Index Scores range from 0-4, with higher scores indicating a worse outcome
Treatment Acceptability	2 months after starting treatment	Treatment Evaluation Inventory scores range from 9 - 45 where higher scores mean a better outcome
Physical and Emotional Functioning - Depressive Symptoms	Baseline,12 weeks, and 26 weeks	Patient-reported Outcomes Measurement Information System (PROMIS) Pediatric Profile v2.0 - Depressive Symptoms T-score, higher scores means higher depressive symptoms. 50 indicates the population mean with a standard deviation of 10. A T-score of 60 is indicative of sub-clinical or elevated levels of depressive symptoms.
Physical and Emotional Functioning - Anxiety	Baseline,12 weeks, and 26 weeks	Patient-reported Outcomes Measurement Information System (PROMIS) Pediatric Profile v2.0 - Anxiety T-score, higher scores means higher levels of anxiety. 50 indicates the population mean with a standard deviation of 10. A T-score of 60 is indicative of sub-clinical or elevated levels of anxiety.
Physical and Emotional Functioning - Peer Relationships	Baseline,12 weeks, and 26 weeks	Patient-reported Outcomes Measurement Information System (PROMIS) Pediatric Profile v2.0 - Peer Relationships T-score, higher scores means better peer relationships. 50 indicates the population mean with a standard deviation of 10. A T-score of 40 is indicative of sub-clinical or reduced quality of peer relationships.
Parent Protectiveness	Baseline,12 weeks, and 26 weeks	Adult Responses to Children's Symptoms Scores range from 0-4 where higher scores mean a worse outcome
Physical and Emotional Functioning - Pain Interference	Baseline,12 weeks, and 26 weeks	Patient-reported Outcomes Measurement Information System (PROMIS) Pediatric Profile v2.0 - Pain Interference T-score, higher scores means more pain interference. 50 indicates the population mean with a standard deviation of 10. A T-score of 60 is indicative of sub-clinical or elevated levels of pain interference.
Health Services Utilization	Baseline and 26 weeks	Client Services Receipt Inventory adapted for sickle cell disease - Number of hospitalizations and/or ED visits
Child Physical and Emotional Functioning - Parent Report, Depression	Baseline,12 weeks, and 26 weeks	Bath Adolescent Pain Questionnaire - Parent version, Depression (0-24). A higher score indicates more impaired functioning for all subscales.
Treatment Experiences - Child	12 weeks and 26 weeks	Self report of treatment experiences. The number of participants with high levels of increased stress or anxiety will be reported.
Child Physical and Emotional Functioning - Parent Report, Social Functioning	Baseline,12 weeks, and 26 weeks	Bath Adolescent Pain Questionnaire - Parent version, Social Functioning (score range: 0-36). A higher score indicates more impaired functioning for all subscales.
Child Physical and Emotional Functioning - Parent Report, Pain Specific Anxiety	Baseline,12 weeks, and 26 weeks	Bath Adolescent Pain Questionnaire - Parent version, Pain Specific Anxiety (0-28). A higher score indicates more impaired functioning for all subscales.
Child Physical and Emotional Functioning - Parent Report, Family Functioning	Baseline,12 weeks, and 26 weeks	Bath Adolescent Pain Questionnaire - Parent, Family Functioning (0-48). A higher score indicates more impaired functioning for all subscales.

Trial Locations

Locations (4): Seattle Children's Hospital
🇺🇸
Seattle, Washington, United States
Emory University
🇺🇸
Atlanta, Georgia, United States
Connecticut Children's Medical Center
🇺🇸
Hartford, Connecticut, United States
The Hospital for Sick Children
🇨🇦
Toronto, Ontario, Canada