GLA:D® Back: Patient Education and Exercises for Self-management of Back Pain

Back Pain, Low Clinical Trial

Official title: GLA:D® Back: Implementation of Group-based Patient Education and Exercises to Support Self-management of Back Pain

Status Recruiting

Clinical Trial Summary

The GLA:D Back project evaluates the implementation of standardised patient education and exercise therapy for people with persistent or recurrent low back pain (LBP) in a hybrid implementation-effectiveness design. This involves evaluating the process of implementation as well as clinician level outcomes and patient level outcomes. GLA:D (Good Life with OsteoArthritis in Denmark) is a non-profit initiative and registered trademark from the University of Southern Denmark. It educates clinicians in delivering evidence-based care for musculoskeletal health conditions and registers outcomes in a clinical registry. GLA:D Back uses only the acronym. The main activity of the implementation strategy is a two-days course for physiotherapists and chiropractors in delivering patient education and exercise therapy that is aimed at supporting patient self-management of LBP. This comes with ready-to-use patient education materials and exercise programs. The course is targeted at chiropractors and physiotherapists, but any health care provider authorised to treat patients with back pain in Denmark can participate, i.e. medical doctors, physiotherapists and chiropractors. The clinical intervention is a group-based program consisting of two sessions of patient education and 8 weeks of supervised exercises. The program uses a cognitive-behavioural approach and the aim of the exercise component is to restore the patient's ability and confidence to move freely. Clinicians decide which patients are offered the program. The implementation process is evaluated in a dynamic process monitoring the penetration, adoption and fidelity of the clinical intervention. The education of clinicians is evaluated via clinician-level outcomes concerning attitudes towards back pain and confidence in managing people with LBP. The clinical intervention and potential effect mechanisms are evaluated at the patient-level in an observational design. Patients who are participating in the GLA:D Back program are followed using measures of knowledge, skills, beliefs, performance, self-efficacy and success in self-management. Effects at a national level will be investigated via data from national registries of health care utilisation and sick-leave. Patient- and clinician reported data are collected in a registry.

Clinical Trial Description

The clinician training courses are open to all interested authorised back pain clinicians practicing in Denmark. The study evaluates courses conducted in 2018 which involves one or two courses for clinicians in each of five Danish regions. The adoption of GLA:D Back is investigated by measuring the extent to which clinicians who have participated in the GLA:D Back course conduct the program in their clinics. Reach of the patient target group is determined by asking clinicians about the degree to which patients offered the treatment accept this. Fidelity with the program is investigated quantitatively by asking about treatment content and recall of key messages via patient questionnaires, and by ensuring that patients' individual goals are registered. The quality of care in terms of delivering the key elements of the intervention will be further explored qualitatively. The profile of patients enrolled in the GLA:D Back programme will be compared between clinics and administrative regions. Clinician level effects are investigated in an observational longitudinal design with clinician reported data collected before the clinician training course, immediately after the course and 4 months later, and with patient-reported information on delivery collected at their three-months follow up. Indicators of implementation are registration of patients in the GLA:D Back registry and that patients report receiving the educational components of care and supervised exercises. Orientation towards treatment of LBP and confidence in managing patients with LBP are evaluated by clinicians' answers to standardised questionnaires. Patient level outcomes are aimed at investigating changes in knowledge, beliefs and skills related to the LBP condition which is hypothesized to lead to improved self-efficacy. The initial measures are related to knowledge skills, beliefs and performance, the next line of outcomes to self-efficacy, then daily activities and quality of life and last health care utilisation and work ability. The compliance with the program is evaluated by patient report of the number of patient education sessions and exercise sessions attended. The registry is delivered by Odense Patient data Explorative Network (OPEN) at University of Southern Denmark and uses REDCap (Vanderbilt University) as the platform for data collection. Clinicians are registered when signing up for the GLA:D Back course and agreeing to participate in research. Patients are registered by the clinician and have links to patient questionnaires sent to their email before beginning the GLA:D Back program and after 3, 6 and 12 months if consenting to their data being used for research. Rather than testing effects on one primary outcome, the study evaluates the implementation process and a number of outcomes based on a logical model of change. ;

Related Conditions & MeSH terms

• Back Pain
• Back Pain, Low
• Low Back Pain

• NCT number: NCT03570463
• Study type: Observational [Patient Registry]
• Source: University of Southern Denmark
• Contact: Alice Kongsted, PhD
• Phone: +4565504531
• Email: akongsted@health.sdu.dk
• Status: Recruiting
• Start date: April 11, 2018
• Completion date: December 2025