iCanCope With Pain: A Smartphone and Web Self-management Program for Adolescents and Young Adults With Chronic Pain

Chronic Pain Clinical Trial

Official title:

iCanCope With Pain: An Integrated Smartphone and Web Self-management Program for Adolescents and Young Adults With Chronic Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02601755
• Other study ID #: 1000047495
• Status: Completed
• Phase: N/A
• Start date: April 1, 2017
• Est. completion date: August 1, 2023

Study information

• Verified date: November 2023
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 302
• Est. completion date: August 1, 2023
• Est. primary completion date: August 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 25 Years

Eligibility

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 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

• Requires urgent CBT treatment as per their health care provider

• Individuals who have received more than 4 CBT sessions for pain management in the past 6 months, as per their health-care provider and self-report

Related Conditions & MeSH terms

• Chronic Pain

Intervention

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.
• 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.

Locations

Country	Name	City	State
Canada	Alberta Children's Hospital	Calgary	Alberta
Canada	Stollery Children's Hospital	Edmonton	Alberta
Canada	University of Alberta	Edmonton	Alberta
Canada	IWK Health Centre	Halifax	Nova Scotia
Canada	Nova Scotia Health Authority/Dalhousie University	Halifax	Nova Scotia
Canada	Hamilton Health Sciences	Hamilton	Ontario
Canada	The Ottawa Hospital	Ottawa	Ontario
Canada	University of Saskatchewan	Saskatoon	Saskatchewan
Canada	Hospital for Sick Children	Toronto	Ontario
Canada	Mount Sinai Hospital	Toronto	Ontario

Sponsors (13)

Lead Sponsor	Collaborator
The Hospital for Sick Children	Alberta Children's Hospital, Centre for Global eHealth Innovation, Dalhousie University, Hamilton Health Sciences Corporation, IWK Health Centre, Mount Sinai Hospital, Canada, Nova Scotia Health Authority, Stollery Children's Hospital, The Ottawa Hospital, University of Alberta, University of Saskatchewan, University of Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Participant Accrual and Dropout Rates	This will be centrally tracked by the clinical research project coordinator (CRPC).	8 weeks
Primary	Intervention fidelity	Any issues or difficulties encountered during implementation of the intervention, control strategy, or outcome measures will be tracked throughout the study by the CRPC.	8 weeks
Primary	Acceptability and Satisfaction	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.	8 weeks
Primary	Engagement with Intervention	Google Analytics will track patterns of app and website usage.	8 weeks
Primary	Adherence	Adherence will be determined using Google Analytics.	8 weeks
Secondary	Pain intensity and interference	Measured using the short form Brief Pain Inventory (BPI), a 15-item tool that measures pain intensity and impact on functioning.	8 weeks
Secondary	Self-efficacy	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.	8 weeks
Secondary	Emotional Functioning	Measured using the Hospital Anxiety and Depression Scale (HADS), a 14-item measure for the assessment of anxiety and depressive symptoms.	8 weeks
Secondary	Sleep Functioning	Measured with the Insomnia Severity Index (ISI), a 7-item self-report questionnaire for assessing the nature, severity, and impact of insomnia.	8 weeks
Secondary	Social Functioning	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.	8 weeks
Secondary	Health-Related Quality of Life	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).	8 weeks
Secondary	Patients' Global Impression of Change	Measured using the PGIC scale, a single item rating by participants of their perceived change during the trial.	8 weeks
Secondary	Pain-Related Knowledge	Measured using a modified version of the Medical Issues, Exercise, Pain and Social Support (MEPS) questionnaire, a 27-item measure.	8 weeks
Secondary	Health Care Utilization	Measured using the Chronic Pain Healthcare Utilization Form. (modified from the Ambulatory and Home Care Record)	8 weeks
Secondary	Adverse effects	Will be tracked using the adverse event form.	8 weeks