GLA:D® Back: Patient Education and Exercises for Self-management of Back Pain
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| ClinicalTrials.gov Identifier: NCT03570463 |
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Recruitment Status :
Recruiting
First Posted : June 27, 2018
Last Update Posted : April 18, 2019
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| Tracking Information | |||||||||
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| First Submitted Date | May 31, 2018 | ||||||||
| First Posted Date | June 27, 2018 | ||||||||
| Last Update Posted Date | April 18, 2019 | ||||||||
| Actual Study Start Date | April 11, 2018 | ||||||||
| Estimated Primary Completion Date | August 31, 2020 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures |
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| Original Primary Outcome Measures |
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| Current Secondary Outcome Measures |
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| Original Secondary Outcome Measures |
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| Current Other Pre-specified Outcome Measures |
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| Original Other Pre-specified Outcome Measures | Same as current | ||||||||
| Descriptive Information | |||||||||
| Brief Title | 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 | ||||||||
| 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. |
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| 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. |
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| Study Type | Observational [Patient Registry] | ||||||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | 12 Months | ||||||||
| Biospecimen | Not Provided | ||||||||
| 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 | ||||||||
| Condition | Back Pain, Low | ||||||||
| Intervention | Behavioral: GLA:D Back
The intervention aims at improving the participant's ability to self-manage low back pain (LBP). The content is based on a cognitive behavioural approach aimed at supporting pain self-efficacy. An individual session at the beginning and the end of the group sessions involve goal-setting and physical tests. Key messages of the patient education include that pain is not a sign of danger and back pain is explained using a behavioural model of (im)balance between demands and capacity rather than emphasising tissue damage. The exercises aim at restoring natural variation in movement and provides guidance for patients in exploring movement rather than teaching exercises in only one correct manner.
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| Study Groups/Cohorts | GLA:D Back
Two 1-hour group sessions of patient education 8 weeks of twice-weekly 1-hour supervised group exercise sessions
Intervention: Behavioral: GLA:D Back
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| Publications * | Kongsted A, Ris I, Kjaer P, Vach W, Morsø L, Hartvigsen J. GLA:D(®) 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. | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status | Recruiting | ||||||||
| Estimated Enrollment |
1500 | ||||||||
| Original Estimated Enrollment | Same as current | ||||||||
| Estimated Study Completion Date | August 31, 2020 | ||||||||
| Estimated Primary Completion Date | August 31, 2020 (Final data collection date for primary outcome measure) | ||||||||
| 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 |
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| Sex/Gender |
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| Ages | 18 Years and older (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts |
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| Listed Location Countries | Denmark | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number | NCT03570463 | ||||||||
| Other Study ID Numbers | DPA 2015-57-0008 SDU 17/30591 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | Alice Kongsted, University of Southern Denmark | ||||||||
| Study Sponsor | University of Southern Denmark | ||||||||
| Collaborators | Not Provided | ||||||||
| Investigators |
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| PRS Account | University of Southern Denmark | ||||||||
| Verification Date | April 2019 | ||||||||