iCanCope With Pain: A Smartphone and Web Self-management Program for Adolescents and Young Adults With Chronic Pain
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02601755|
Recruitment Status : Recruiting
First Posted : November 10, 2015
Last Update Posted : April 25, 2017
|Condition or disease||Intervention/treatment||Phase|
|Chronic Pain||Behavioral: iCanCope app and website Behavioral: Attention control group||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||iCanCope With Pain: An Integrated Smartphone and Web Self-management Program for Adolescents and Young Adults With Chronic Pain|
|Actual Study Start Date :||April 1, 2017|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||May 2018|
Experimental: iCanCope app and website
Intervention: Behavioral: iCanCope app and website
Behavioral: iCanCope 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.
Active Comparator: Attention control group
Intervention: Behavioral: Attention control group
Behavioral: Attention 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.
- Participant Accrual and Dropout Rates [ Time Frame: 8 weeks ]This will be centrally tracked by the clinical research project coordinator (CRPC).
- Intervention fidelity [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 8 weeks ]Google Analytics will track patterns of app and website usage.
- Adherence [ Time Frame: 8 weeks ]Adherence will be determined using Google Analytics.
- Pain intensity and interference [ Time Frame: 8 weeks ]Measured using the short form Brief Pain Inventory (BPI), a 15-item tool that measures pain intensity and impact on functioning.
- Self-efficacy [ Time Frame: 8 weeks ]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 [ Time Frame: 8 weeks ]Measured using the Hospital Anxiety and Depression Scale (HADS), a 14-item measure for the assessment of anxiety and depressive symptoms.
- Sleep Functioning [ Time Frame: 8 weeks ]Measured with the Insomnia Severity Index (ISI), a 7-item self-report questionnaire for assessing the nature, severity, and impact of insomnia.
- Social Functioning [ Time Frame: 8 weeks ]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 [ Time Frame: 8 weeks ]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 [ Time Frame: 8 weeks ]Measured using the PGIC scale, a single item rating by participants of their perceived change during the trial.
- Pain-Related Knowledge [ Time Frame: 8 weeks ]Measured using a modified version of the Medical Issues, Exercise, Pain and Social Support (MEPS) questionnaire, a 27-item measure.
- Health Care Utilization [ Time Frame: 8 weeks ]Measured using the Chronic Pain Healthcare Utilization Form. (modified from the Ambulatory and Home Care Record)
- Adverse effects [ Time Frame: 8 weeks ]Will be tracked using the adverse event form.
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): NCT02601755
|Contact: Jennifer Stinson N Stinson, RN, PhD||416-813-7654 ext firstname.lastname@example.org|
|Contact: Chitra Lalloo, PhD||416-813-7654 ext email@example.com|
|Stollery Children's Hospital||Recruiting|
|Edmonton, Alberta, Canada, T6G 2B7|
|Contact: Michelle Verrier 780-407-8615 firstname.lastname@example.org|
|Principal Investigator: Mark Simmonds, MD|
|University of Alberta||Recruiting|
|Edmonton, Alberta, Canada, T6G 2R7|
|Contact: Michelle Verrier 780-407-8615 email@example.com|
|Principal Investigator: Saifee Rashiq, MD|
|Principal Investigator: Bruce Dick, PhD|
|Canada, Nova Scotia|
|Nova Scotia Health Authority/Dalhousie University||Not yet recruiting|
|Halifax, Nova Scotia, Canada, B3H 2E1|
|Contact: Sara Whynot, MLT DHSA 902-473-5030 firstname.lastname@example.org|
|Principal Investigator: Karim Mukhida, MD, PhD, FRCPC|
|IWK Health Centre||Not yet recruiting|
|Halifax, Nova Scotia, Canada, B3K 6R8|
|Contact: Sharon Amey, MDE 902-470-7703 Sharon.Amey@iwk.nshealth.ca|
|Principal Investigator: Jill Chorney, PhD|
|Mount Sinai Hospital||Not yet recruiting|
|Toronto, Ontario, Canada, M5G 1X5|
|Contact: Denise Paneduro, MA 416-586-4800 ext 2082 DPaneduro@mtsinai.on.ca|
|Principal Investigator: Allan Gordon, MD, FRCPC|
|Hospital for Sick Children||Recruiting|
|Toronto, Ontario, Canada, M5G 1X8|
|Contact: Lauren Harris, OT (Reg) 416-813-7654 ext 302314 email@example.com|
|Contact: Chitra Lalloo, BHSc, PhD 416-813-7654 ext 202332 firstname.lastname@example.org|
|Principal Investigator: Jennifer Stinson, RN, PhD|