iCanCope With Sickle Cell Pain

Sickle Cell Disease Clinical Trial

Official title:

iCanCope With Sickle Cell Disease: A Mobile Pain Management Intervention for Adolescents

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03201874
• Other study ID #: R01HD086978
• Status: Completed
• Phase: N/A
• Start date: January 1, 2018
• Est. completion date: August 31, 2022

Study information

• Verified date: November 2023
• Source: Seattle Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 137
• Est. completion date: August 31, 2022
• Est. primary completion date: August 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anemia, Sickle Cell
• Sickle Cell Disease

Intervention

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.
• Education
Education about sickle cell disease to increase disease knowledge

Locations

Country	Name	City	State
Canada	The Hospital for Sick Children	Toronto	Ontario
United States	Emory University	Atlanta	Georgia
United States	Connecticut Children's Medical Center	Hartford	Connecticut
United States	Seattle Children's Hospital	Seattle	Washington

Sponsors (8)

Lead Sponsor	Collaborator
Seattle Children's Hospital	Boston Medical Center, Connecticut Children's Medical Center, Emory University, Northwestern University, The Hospital for Sick Children, University of Florida, University of Mississippi Medical Center

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Diary - Average Daily Pain	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	Baseline,12 weeks, and 26 weeks
Primary	Pain Diary - Average Daily Activity Limitations	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	Baseline,12 weeks, and 26 weeks
Primary	Adaptive Coping - Coping Attempts	Coping Strategies Questionnaire for Sickle Cell Disease - Coping Attempts Factor Scores range from 0 - 180, higher scores mean a better outcome	Baseline,12 weeks, and 26 weeks
Secondary	Treatment Acceptability	Treatment Evaluation Inventory scores range from 9 - 45 where higher scores mean a better outcome	2 months after starting treatment
Secondary	Physical and Emotional Functioning - Depressive Symptoms	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.	Baseline,12 weeks, and 26 weeks
Secondary	Physical and Emotional Functioning - Anxiety	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.	Baseline,12 weeks, and 26 weeks
Secondary	Physical and Emotional Functioning - Mobility	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.	Baseline,12 weeks, and 26 weeks
Secondary	Physical and Emotional Functioning - Pain Interference	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.	Baseline,12 weeks, and 26 weeks
Secondary	Physical and Emotional Functioning - Fatigue	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.	Baseline,12 weeks, and 26 weeks
Secondary	Physical and Emotional Functioning - Peer Relationships	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.	Baseline,12 weeks, and 26 weeks
Secondary	Patient Global Impression of Change	Global rating for improvement in pain and functioning Scores range from 1-7 where higher scores mean a better outcome	12 weeks and 26 weeks
Secondary	Parent Protectiveness	Adult Responses to Children's Symptoms Scores range from 0-4 where higher scores mean a worse outcome	Baseline,12 weeks, and 26 weeks
Secondary	Health Services Utilization	Client Services Receipt Inventory adapted for sickle cell disease - Number of hospitalizations and/or ED visits	Baseline and 26 weeks
Secondary	Parent Psychological Distress	Symptom Checklist 90 - Global Severity Index Scores range from 0-4, with higher scores indicating a worse outcome	Baseline,12 weeks, and 26 weeks
Secondary	Child Physical and Emotional Functioning - Parent Report, Social Functioning	Bath Adolescent Pain Questionnaire - Parent version, Social Functioning (score range: 0-36). A higher score indicates more impaired functioning for all subscales.	Baseline,12 weeks, and 26 weeks
Secondary	Child Physical and Emotional Functioning - Parent Report, Physical Functioning	Bath Adolescent Pain Questionnaire - Parent version Physical Functioning (0-36). A higher score indicates more impaired functioning for all subscales.	Baseline,12 weeks, and 26 weeks
Secondary	Child Physical and Emotional Functioning - Parent Report, Depression	Bath Adolescent Pain Questionnaire - Parent version, Depression (0-24). A higher score indicates more impaired functioning for all subscales.	Baseline,12 weeks, and 26 weeks
Secondary	Child Physical and Emotional Functioning - Parent Report, General Anxiety	Bath Adolescent Pain Questionnaire - Parent version, General Anxiety (0-28). A higher score indicates more impaired functioning for all subscales.	Baseline,12 weeks, and 26 weeks
Secondary	Child Physical and Emotional Functioning - Parent Report, Pain Specific Anxiety	Bath Adolescent Pain Questionnaire - Parent version, Pain Specific Anxiety (0-28). A higher score indicates more impaired functioning for all subscales.	Baseline,12 weeks, and 26 weeks
Secondary	Child Physical and Emotional Functioning - Parent Report, Family Functioning	Bath Adolescent Pain Questionnaire - Parent, Family Functioning (0-48). A higher score indicates more impaired functioning for all subscales.	Baseline,12 weeks, and 26 weeks
Secondary	Child Physical and Emotional Functioning - Parent Report, Development	Bath Adolescent Pain Questionnaire - Parent version, Development (0-44). A higher score indicates more impaired functioning for all subscales.	Baseline,12 weeks, and 26 weeks
Secondary	Treatment Experiences - Child	Self report of treatment experiences. The number of participants with high levels of increased stress or anxiety will be reported.	12 weeks and 26 weeks