Chronic Pain
Conditions
Brief summary
Chronic pain in adolescents and young adults (AYA, aged 15-25) is a common problem. Pain that is not treated properly can reduce quality of life. Programs to help AYA learn to live with and manage pain are very important. Our team is developing a smartphone application (app) and website for AYA with chronic pain. The app will help AYA to track pain, sleep, mood, activities, and exercise and help AYA set and achieve goals. The website will give information about pain and how to manage it independently. We will build the program and make sure it is easy to use and understand. We will also test if the program can be put into practice as planned and if AYA using the program feel less pain, have less limitations, and a better quality of life.
Interventions
BEHAVIORALiCanCope app and website
In addition to standard medical care, adolescents and young adults in the experimental group will receive access to the "iCanCope with Pain" smartphone app and website for 8 weeks. The app consists of daily pain symptom tracking (pain intensity, sleep, mood, physical activity, and fatigue), goal setting, in-the moment coping strategies, as well as a social community component. The website provides chronic pain-specific education, self-management strategies, and resources.
BEHAVIORALAttention control group
The control group is designed to control for the potential effects on outcomes of time, attention, smartphone and computer use during the intervention. In addition to standard medical care, adolescents and young adults in the attention control group will receive access to the "iCanCope with Pain" smartphone app (control version, with limited functionality), and a pain resource website without access to self-management strategies.
Sponsors
The Hospital for Sick Children
Mount Sinai Hospital, Canada
IWK Health Centre
Nova Scotia Health Authority
Stollery Children's Hospital
University of Alberta
Dalhousie University
Centre for Global eHealth Innovation
University of Toronto
University of Saskatchewan
Alberta Children's Hospital
The Ottawa Hospital
Hamilton Health Sciences Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
15 Years to 25 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosed with chronic pain of at least 3 months duration according to medical chart * Able to speak and read English * Willing and able to complete online measures * Participants are active patients at pain clinic at one of the respective participating study sites * Have been on a stable dose of medications for at least 4 weeks prior to entering the study according to medical chart * Have access to an Internet-connected computer according to self-report.
Exclusion criteria
* Moderate to severe cognitive impairments, as assessed by reviewing medical chart and consultation with the patient's healthcare provider * Major co-morbid psychiatric (e.g. conversion disorder, depression, anxiety disorder) illness that may impact patient's ability to understand and use the iCanCope with Pain intervention via self-report, as determined by their health care provider * Patient from the department of haemology/oncology * Participated in the Phase 2B iCanCope usability study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participant Accrual and Dropout Rates | 6 months | This will be centrally tracked by the clinical research project coordinator (CRPC). |
| Intervention fidelity | 8 weeks | Any issues or difficulties encountered during implementation of the intervention, control strategy, or outcome measures will be tracked throughout the study by the CRPC. |
| Acceptability and Satisfaction | 8 weeks | Participants in the intervention arm will complete the Acceptability e-scale (AES) post-intervention. In addition, a subset of participants from the intervention group will be offered to participate in a qualitative feedback interview to further explore acceptability and satisfaction of the intervention. |
| Engagement with Intervention | 8 weeks | Google Analytics will track patterns of app and website usage. |
| Adherence | 8 weeks | Adherence will be determined using Google Analytics. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain intensity and interference | 6 months | Measured using the short form Brief Pain Inventory (BPI), a 15-item tool that measures pain intensity and impact on functioning. |
| Self-efficacy | 6 months | Measured with the Pain Self-Efficacy Questionnaire (PSEQ), a 10-item scale that requires patients to take their pain into account when rating their self-efficacy beliefs. |
| Emotional Functioning | 6 months | Measured using the Hospital Anxiety and Depression Scale (HADS), a 14-item measure for the assessment of anxiety and depressive symptoms. |
| Sleep Functioning | 6 months | Measured with the Insomnia Severity Index (ISI), a 7-item self-report questionnaire for assessing the nature, severity, and impact of insomnia. |
| Social Functioning | 6 months | Measured with the Perceived Social Support from Friends (PSS-Fr) Scale, a 20-item scale that assesses the extent to which an individual perceives that their friends fulfill their needs for support. |
| Health-Related Quality of Life | 6 months | Measured using the SF-36 Health Survey, a 36-item self-report scale with 8 subscales (Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health). |
| Patients' Global Impression of Change | 6 months | Measured using the PGIC scale, a single item rating by participants of their perceived change during the trial. |
| Pain-Related Knowledge | 6 months | Measured using a modified version of the Medical Issues, Exercise, Pain and Social Support (MEPS) questionnaire, a 27-item measure. |
| Health Care Utilization | 6 months | Measured using the Chronic Pain Healthcare Utilization Form. (modified from the Ambulatory and Home Care Record) |
| Adverse effects | 6 months | Will be tracked using the adverse event form. |
Countries
Canada
Outcome results
None listed