Clinical trial NCT03570463: GLA:D® Back: Patient Education and Exercises for Self-management of Back Pain
Official title: GLA:D® Back: Implementation of Group-based Patient Education and Exercises to Support Self-management of Back Pain
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Back Pain, Low
Lead sponsor: University of Southern Denmark
Sponsor class: OTHER
First posted: 2018-06-27
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants are people consulting a physiotherapist or chiropractor who are trained in the GLA:D Back program. The decision to enrol a patient in GLA:D Back is at the discretion of the clinician in a dialogue with the patient, when clinicians judge that the patient would benefit from improved self-management skills

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

The decision to invite a patient to participate in the GLA:D Back program is at the discretion of the clinician. Clinicians are taught that the program was developed for people with persistent or recurrent low back pain and a need for improved self-management

Exclusion Criteria:

Back pain related to specific spinal or systemic pathology, signs of acute nerve root involvement

Primary outcomes:
measure: Brief Illness Perceptions Questionnaire (B-IPQ)
timeFrame: Change from baseline to 3 months
measure: Fear Avoidance Beliefs Questionnaire (FABQ)
timeFrame: Change from baseline to 3 months
measure: The Arthritis Self-efficacy (ASES)
timeFrame: Change from baseline to 6 months
measure: Quality of Life (General health)
timeFrame: Proportions in response categories baseline to 12 months
measure: Quality of Life (Social functioning)
timeFrame: Change from baseline to 12 months
measure: Quality of Life (Mental functioning)
timeFrame: Change from baseline to 12 months
measure: General Health
timeFrame: Change from baseline to 12 months
measure: Health care visits primary care
timeFrame: During 12 months after participation
measure: Health care visits hospital
timeFrame: During 12 months after participation
measure: Imaging
timeFrame: During 12 months after participation
measure: Pain medication
timeFrame: During 12 months after participation
Secondary outcomes:
measure: Confidence with exercises
timeFrame: Change from baseline to 3 months
measure: Self-assessed physical capacity
timeFrame: Change from baseline to 3 months
measure: Satisfaction with care
timeFrame: 3 months
measure: Patient reported harms or side effects
timeFrame: 3 months
measure: Oswestry Disability Index
timeFrame: Change from baseline to 3, 6, 12 months
measure: Pain Intensity
timeFrame: Change from baseline to 3, 6, 12 months
measure: Work ability
timeFrame: During 12 months after participation
measure: Brief Illness Perceptions Questionnaire (B-IPQ)
timeFrame: Change from baseline to 6, 12 months
measure: Fear Avoidance Beliefs Questionnaire (FABQ)
timeFrame: Change from baseline to 6, 12 months
measure: The Arthritis Self-efficacy (ASES)
timeFrame: Change from baseline to 3, 12 months
measure: Quality of Life (General Health)
timeFrame: Proportions in response categories baseline to 3, 6 months
measure: Quality of Life (Social functioning)
timeFrame: Change from baseline to 3, 6 months
measure: Quality of Life /Mental functioning)
timeFrame: Change from baseline to 3, 6 months
Other outcomes:
measure: The Pain Attitudes and Beliefs Scale for Physiotherapists (PABS-PT)
timeFrame: Change from before course participation to 4 months
measure: Practitioner Confidence Scale (PCS)
timeFrame: Change from before course participation to 4 months
measure: The Determinants of Implementation Behavior Questionnaire (DIBQ)
timeFrame: Immediately after curse participation and 4 months
measure: Adoption
timeFrame: Within 6 months
measure: Patients participation
timeFrame: 4 months
measure: Patient compliance
timeFrame: 3 months
Locations:
city: Odense
country: Denmark
facility: University of Southern Denmark (central unit)
Study officials:
affiliation: University of Southern Denmark
name: Alice Kongsted, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kjaer P, Kongsted A, Ris I, Abbott A, Rasmussen CDN, Roos EM, Skou ST, Andersen TE, Hartvigsen J. GLA:D(R) Back group-based patient education integrated with exercises to support self-management of back pain - development, theories and scientific evidence. BMC Musculoskelet Disord. 2018 Nov 29;19(1):418. doi: 10.1186/s12891-018-2334-x.
citation: Kongsted A, Hartvigsen J, Boyle E, Ris I, Kjaer P, Thomassen L, Vach W. GLA:D(R) Back: group-based patient education integrated with exercises to support self-management of persistent back pain - feasibility of implementing standardised care by a course for clinicians. Pilot Feasibility Stud. 2019 May 9;5:65. doi: 10.1186/s40814-019-0448-z. eCollection 2019.
citation: Kongsted A, Ris I, Kjaer P, Vach W, Morso L, Hartvigsen J. GLA:D(R) Back: implementation of group-based patient education integrated with exercises to support self-management of back pain - protocol for a hybrid effectiveness-implementation study. BMC Musculoskelet Disord. 2019 Feb 18;20(1):85. doi: 10.1186/s12891-019-2443-1.
citation: Ris I, Boyle E, Myburgh C, Hartvigsen J, Thomassen L, Kongsted A. Factors influencing implementation of the GLA:D Back, an educational/exercise intervention for low back pain: a mixed-methods study. JBI Evid Implement. 2021 May 10;19(4):394-408. doi: 10.1097/XEB.0000000000000284.
citation: Morso L, Bogh SB, Ris I, Kongsted A. Mind the gap - Evaluation of the promotion initiatives for implementation of the GLA:D(R) back clinician courses. Musculoskelet Sci Pract. 2021 Jun;53:102373. doi: 10.1016/j.msksp.2021.102373. Epub 2021 Mar 27.
citation: Ris I, Broholm D, Hartvigsen J, Andersen TE, Kongsted A. Adherence and characteristics of participants enrolled in a standardised programme of patient education and exercises for low back pain, GLA:D(R) Back - a prospective observational study. BMC Musculoskelet Disord. 2021 May 22;22(1):473. doi: 10.1186/s12891-021-04329-y.
citation: Joern L, Kongsted A, Thomassen L, Hartvigsen J, Ravn S. Pain cognitions and impact of low back pain after participation in a self-management program: a qualitative study. Chiropr Man Therap. 2022 Feb 21;30(1):8. doi: 10.1186/s12998-022-00416-6.
citation: Nim CG, Kongsted A, Downie A, Vach W. Temporal stability of self-reported visual back pain trajectories. Pain. 2022 Nov 1;163(11):e1104-e1114. doi: 10.1097/j.pain.0000000000002661. Epub 2022 Apr 25.