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Clinical Trials/NCT05319652
NCT05319652
Completed
Not Applicable

Co-development and Assessment of the Feasibility and Potential Effects of an Online Self-management Program for Chronic Non-cancer Pain

CHU de Quebec-Universite Laval1 site in 1 country63 target enrollmentJune 6, 2022
ConditionsChronic Pain

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Pain
Sponsor
CHU de Quebec-Universite Laval
Enrollment
63
Locations
1
Primary Endpoint
Feasibility of the recruitment
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

Based on a mixed-methods design, the objective of this trial is to assess the feasibility and acceptability of the "Agir pour moi" program, an 8-week online self-management program for chronic non-cancer pain (CNCP). The investigators will also explore its potential effects on self-efficacy, pain interference, pain severity, anxiety, depression, catastrophizing, and global impression of change in adults with CNCP awaiting services from a chronic pain multidisciplinary treatment center.

Detailed Description

The mixed-methods sequential explanatory design combines a quantitative questionnaire-based study with a subsequent in depth qualitative approach.

Registry
clinicaltrials.gov
Start Date
June 6, 2022
End Date
March 23, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
CHU de Quebec-Universite Laval
Responsible Party
Principal Investigator
Principal Investigator

Anne-Marie-Pinard

Anesthesiologist

CHU de Quebec-Universite Laval

Eligibility Criteria

Inclusion Criteria

  • Age ≥ 18 years;
  • live with CNCP for more than 3 months;
  • read and understand French easily;
  • have access to a computer and high-speed Internet;
  • be available to take part in the project for 6 to 8 months;
  • not having started a new treatment for pain within the last month;
  • agree to notify the team before starting a new treatment;
  • be able to give informed consent.

Exclusion Criteria

  • be supported by a multidisciplinary treatment center or be likely to be in the short term;
  • having participated in a CNCP self-management program within the last year;
  • be awaiting scheduled surgical treatment within six months.

Outcomes

Primary Outcomes

Feasibility of the recruitment

Time Frame: Baseline

* Number of potentially eligible adults referred by the multidisciplinary treatment center over the recruitment period * Number of referred adults who respond to the invitation * Number of referred adults who consent to participate in the study * Number of interested adults excluded based on inclusion/exclusion criteria

Feasibility of data collection

Time Frame: 3 months post-intervention

* Rate of response to the questionnaires * Rate of completed questionnaires (no missing data)

Acceptability

Time Frame: 4 months post-intervention

Qualitative data from semi-structured interviews

Adherence to the program

Time Frame: Post-intervention (8 weeks)

Completion rate of the program (completion is following ≥ 75% of the lessons)

Secondary Outcomes

  • Change in pain severity and pain interference: French version of the Brief Pain Inventory (BPI)(Baseline; Post-intervention (8 weeks); 3 months post-intervention)
  • Patient Global Impression of Change Scale (PGIC)(Post-intervention (8 weeks); 3 months post-intervention)
  • Change in anxiety and depression: French version of the Hospital Anxiety and Depression Scale (HADS)(Baseline; Post-intervention (8 weeks); 3 months post-intervention)
  • Change in self-efficacy: French version of the Pain Self-Efficacy Questionnaire (PSEQ)(Baseline; Post-intervention (8 weeks); 3 months post-intervention)
  • Change in pain catastrophizing: French version of the Pain Catastrophizing Scale (PCS)(Baseline; Post-intervention (8 weeks); 3 months post-intervention)

Study Sites (1)

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