GLA:D® Back: Implementation of Group-based Patient Education and Exercises to Support Self-management of Back Pain
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,500
- 试验地点
- 1
- 主要终点
- Pain medication
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Back pain related to specific spinal or systemic pathology, signs of acute nerve root involvement
结局指标
主要结局
Pain medication
时间窗: During 12 months after participation
Prescriptions of pain medication from national registries
Fear Avoidance Beliefs Questionnaire (FABQ)
时间窗: Change from baseline to 3 months
FABQ physical activity subscale (0 = no fear avoidance beliefs; 24 = highest possible fear avoidance)
The Arthritis Self-efficacy (ASES)
时间窗: Change from baseline to 6 months
ASES subscales of pain and other symptoms. Each item is scored on a 0 - 10 scale (0 = very uncertain; 10 = very certain)
General Health
时间窗: Change from baseline to 12 months
Health thermometer from Eq-5D, score 0= worst imaginable to 100= best imaginable
Quality of Life (Social functioning)
时间窗: Change from baseline to 12 months
The 36-Item Short Form Health Survey (SF-36) subdomain social functioning, transformed score 0-100
Health care visits primary care
时间窗: During 12 months after participation
Number of primary care visits from national registries
Health care visits hospital
时间窗: During 12 months after participation
Number of hospital visits due to LBP from national registries
Imaging
时间窗: During 12 months after participation
x-rays, MRI and CT-scans of lower back from national registries
Brief Illness Perceptions Questionnaire (B-IPQ)
时间窗: Change from baseline to 3 months
Nine items covering the constructs of consequences, timeline (expectations of prognosis), personal control, treatment control, identity (extent of symptoms), coherence (understanding of symptoms), emotional representation, concerns, and cause. Each of the items 1 to 8 are scored 0 - 10. If internal consistency allows so a sum score is calculated (0-80). Cause is registered as text.
Quality of Life (General health)
时间窗: Proportions in response categories baseline to 12 months
The 36-Item Short Form Health Survey (SF-36 item1); 5-point likert scale
Quality of Life (Mental functioning)
时间窗: Change from baseline to 12 months
The 36-Item Short Form Health Survey (SF-36) subdomain mental functioning, transformed score 0-100
次要结局
- Work ability(During 12 months after participation)
- Patient reported harms or side effects(3 months)
- Quality of Life (General Health)(Proportions in response categories baseline to 3, 6 months)
- Satisfaction with care(3 months)
- Quality of Life (Social functioning)(Change from baseline to 3, 6 months)
- Confidence with exercises(Change from baseline to 3 months)
- Quality of Life /Mental functioning)(Change from baseline to 3, 6 months)
- Oswestry Disability Index(Change from baseline to 3, 6, 12 months)
- Pain Intensity(Change from baseline to 3, 6, 12 months)
- The Arthritis Self-efficacy (ASES)(Change from baseline to 3, 12 months)
- Self-assessed physical capacity(Change from baseline to 3 months)
- Brief Illness Perceptions Questionnaire (B-IPQ)(Change from baseline to 6, 12 months)
- Fear Avoidance Beliefs Questionnaire (FABQ)(Change from baseline to 6, 12 months)
研究者
Alice Kongsted
Professor wsr
University of Southern Denmark