iCanCope With Post-Operative Pain (iCanCope PostOp)

Pain, Chronic Clinical Trial

Official title:

iCanCope With Post-Operative Pain (iCanCope PostOp): Development of a Smartphone-based Pain Self-management Program for Adolescents Following Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05382962
• Other study ID #: 1000070021
• Status: Recruiting
• Phase: N/A
• Start date: September 28, 2021
• Est. completion date: January 28, 2024

Study information

• Verified date: May 2023
• Source: The Hospital for Sick Children
• Contact: Jennifer Stinson, RN, PhD
• Phone: 416-813-7654
• Email: jennifer.stinson[@]sickkids.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

There are few applications available in the community to help teenagers manage pain after surgery. The focus of this study is to better understand the pain experience of children after having surgery and to design a Smartphone app called "iCanCope with Post-Operative Pain" (iCanCope PostOp), to help children and parents to better manage pain at home after surgery. The app will help keep track of pain, provide information about the teenager's surgery and provides "in-the-moment" advice wherever and whenever the patient needs it.

Description:

More than 80,000 Canadian children undergo surgery each year. Despite evidence-based pain management and clinical standards, moderate to severe postoperative pain in children is common. Inadequate postoperative pain management contributes to poor health outcomes, increased opioid use, and the development of chronic postsurgical pain. Successful postoperative pain management requires regular monitoring and treatment of pain after hospital discharge. Smartphones are nearly ubiquitous, and growing evidence supports their use to overcome barriers to pain care. Computerized clinical decision support systems (CDSS) can improve pain self-management by tracking symptoms over time and offering tailored evidence-informed pain management advice based on standardized algorithms. A comprehensive and sustainable approach is needed to address poorly managed pediatric postoperative pain in the home setting. To address these gaps in care, we are developing "iCanCope with Post-Operative Pain" (or iCanCope PostOp), a smartphone-based CDSS app that provides remote, in-the-moment advice to improve pain and health-related quality of life (HRQL) for adolescents following surgery.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: January 28, 2024
• Est. primary completion date: January 28, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 18 Years

Eligibility

Inclusion Criteria:

1. aged 12 to 18 years;

2. own a smartphone compatible with the iCanCope app (iOS or Android);

3. diagnosed with adolescent idiopathic scoliosis or pectus carinatum or pectus excavatum;

4. are able to speak and read English; and

5. scheduled to undergo scoliosis or minimally invasive pectus repair surgery.

Exclusion Criteria:

1. significant cognitive impairment or other co-existing medical condition that could limit the ability to use the iCanCope app, as identified by their health care provider;

2. participated in a previous study of iCanCope PostOp;

3. a diagnosed chronic pain condition not related to the surgical condition; or

Related Conditions & MeSH terms

• Chronic Pain
• Pain, Chronic
• Pain, Postoperative

Intervention

Behavioral:
• iCanCope Post Op Application
The iCanCope program is designed to enhance pain self-management and self-efficacy, defined as perception of one's ability to successfully produce a desired effect in a task or behavior affecting their life. The intervention will be delivered on the iOS or Android smartphone platform depending on the participant's device. Usage of app features will be centrally tracked by the research team using Analytics Platform to Evaluate Effective Engagement (APEEE), developed at the Centre for Global eHealth Innovation. Participants will receive alerts through iCanCope to complete a pain diary check-in once per week preoperatively, twice per day over the initial 2-week postoperative period, and once per day for the subsequent 2-week period.

Locations

Country	Name	City	State
Canada	Hospital for Sick Children	Toronto	Ontario
United States	Boston Children's Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
The Hospital for Sick Children	Boston Children's Hospital

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Medication utilization	Self-report, investigator developed (Prescribed and over-the-counter pain medication)	12 weeks
Other	Health care utilization	Self-report, investigator developed (Health care visits to various providers, Hospital stay, prescriptions, and admission data from EMR)	12 weeks
Other	Child Surgical Worries	Measured using the Child Surgical Worries Questionnaire, a 27-item self-report measure assessing worries caused by hospitalization and surgery. Patients rate how worried they are about various situations, using the following scale: 0=not at all worried, 1=a little worried, 2=moderately worried, 3=considerably worried, 4=extremely worried.	2 weeks
Other	Parent Catastrophizing (Parent Outcome)	Measured using the Pain Catastrophizing Scale - Parent (PCS-P), a 13-item questionnaire concerning the different thoughts and feelings parents may have when their child experiences pain. Items assessing catastrophic thoughts and feelings about their child's pain use a Likert-type 5-point scale (0 = "not at all" to 4 = "extremely"). The PCS-P yields three subscale scores for rumination, magnification, and helplessness, as well as a total score ranging from 0 to 52.	12 weeks
Primary	Participant Accrual and Dropout Rates	This will be centrally tracked by the clinical research project coordinator (CRPC).	12 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.	12 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.	12 weeks
Primary	Engagement with Intervention	Google Analytics will track patterns of app and website usage.	12 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.	12 weeks
Secondary	Sleep Functioning	Measured with the PROMIS Pediatric Sleep Disturbance - Short Form 4a, a 4-item measure for assessing sleep disturbance. Each item asks the child receiving care to rate the severity of his or her sleep disturbance during the past 7 days. Each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in score from 8 to 40 with higher scores indicating greater severity of sleep disturbance.	12 weeks
Secondary	Physical Function	Measured using the PROMIS Pediatric Mobility SF, an 8-item questionnaire designed to investigate the general impact that the patient's lower limbs mobility had on their daily activity tasks (such as playing with friends or walking up the stairs). Each item is scored from 1 (not able to do it0 to 5 (with no trouble). As per PROMIS guidelines, raw score is calculated as the sum of each item score. Scale score was calculated from raw score using the PROMIS conversion table.	12 weeks
Secondary	Depressive Symptoms	Measured using the PROMIS Pediatric Depressive Symptoms SF, an 8-item questionnaire designed to determine how often one is experiencing specific depressive symptoms in the past 7 days. Each item on the measure is rated on a 5-point scale (1=never; 2=almost never; 3=sometimes; 4=often; and 5=almost always) with a range in score from 14 to 70 with higher scores indicating greater severity of depression.	12 weeks
Secondary	Anxiety	Measured using the PROMIS Anxiety SF, the 13-item questionnaire that assesses the pure domain of anxiety in children and adolescents. Each item asks the child receiving care to rate the severity of his or her anxiety during the past 7 days. Each item on the measure is rated on a 5-point scale (1=never; 2=almost never; 3=sometimes; 4=often; and 5=almost always) with a range in score from 13 to 65 with higher scores indicating greater severity of anxiety.	12 weeks
Secondary	Overall health	Measured using the Patients Global Impression of Change (PGIC), that reflects a patient's belief about the efficacy of treatment. Patients rate their change as "very much improved," "much improved," "minimally improved," "no change," "minimally worse," "much worse," or "very much worse."	12 weeks
Secondary	School attendance	Self-report, investigator developed	12 weeks