N/A
Completed N=111
iCanCope With Sickle Cell Pain
Source: ClinicalTrials.gov NCT03201874 ↗Enrolled (actual)
111
Serious AEs
0.0%
Results posted
Dec 2023
Primary outcomePrimary: Pain Diary - Average Daily Pain — 2.7; 3.3; 2.6; 3.3 units on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain Diary - Average Daily Pain |
2.7; 3.3; 2.6; 3.3; 2.9; 2.1 | — |
| PRIMARY Pain Diary - Average Daily Activity Limitations |
14.1; 13.2; 14.8; 10.6; 12.9; 9.0 | — |
| PRIMARY Adaptive Coping - Coping Attempts |
78.9; 79.6; 83.3; 88.9; 73.9; 85.7 | — |
| SECONDARY Treatment Acceptability |
34.6; 34.7 | — |
| SECONDARY Physical and Emotional Functioning - Depressive Symptoms |
52.4; 49.7; 52.3; 50.8; 52.4; 49.3 | — |
| SECONDARY Physical and Emotional Functioning - Anxiety |
50.1; 50.5; 50.3; 48.6; 49.9; 46.9 | — |
| SECONDARY Physical and Emotional Functioning - Mobility |
44.2; 42.8; 43.0; 43.2; 44.2; 45.4 | — |
| SECONDARY Physical and Emotional Functioning - Pain Interference |
59.9; 60.0; 59.2; 57.1; 58.6; 54.7 | — |
| SECONDARY Physical and Emotional Functioning - Fatigue |
54.5; 57.2; 55.5; 54.8; 57.3; 53.2 | — |
| SECONDARY Physical and Emotional Functioning - Peer Relationships |
44.4; 49.2; 43.3; 45.4; 43.0; 46.6 | — |
| SECONDARY Patient Global Impression of Change |
3.9; 4.1; 3.7; 4.0 | — |
| SECONDARY Parent Protectiveness |
2.1; 1.8; 1.9; 1.5; 1.7; 1.5 | — |
| SECONDARY Health Services Utilization |
2.9; 4.0; 3.3; 2.5 | — |
| SECONDARY Parent Psychological Distress |
0.59; 0.41; 0.51; 0.33; 0.55; 0.42 | — |
| SECONDARY Child Physical and Emotional Functioning - Parent Report, Social Functioning |
12.4; 12.9; 12.9; 12.4; 12.9; 13.7 | — |
| SECONDARY Child Physical and Emotional Functioning - Parent Report, Physical Functioning |
8.4; 10.3; 10.2; 9.7; 10.3; 9.7 | — |
| SECONDARY Child Physical and Emotional Functioning - Parent Report, Depression |
7.4; 6.8; 7.6; 6.5; 7.3; 7.7 | — |
| SECONDARY Child Physical and Emotional Functioning - Parent Report, General Anxiety |
6.7; 7.4; 7.8; 7.0; 7.4; 8.8 | — |
| SECONDARY Child Physical and Emotional Functioning - Parent Report, Pain Specific Anxiety |
12.7; 12.2; 12.9; 11.1; 11.5; 10.8 | — |
| SECONDARY Child Physical and Emotional Functioning - Parent Report, Family Functioning |
13.5; 13.4; 13.5; 12.9; 13.2; 12.9 | — |
| SECONDARY Child Physical and Emotional Functioning - Parent Report, Development |
15.0; 15.7; 15.3; 14.5; 15.5; 14.7 | — |
| SECONDARY Treatment Experiences - Child |
1; 0; 2; 0 | — |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT03201874). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.