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

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ClinicalTrials.gov Identifier: NCT03570463
Recruitment Status : Recruiting
First Posted : June 27, 2018
Last Update Posted : April 18, 2019
Sponsor:
Information provided by (Responsible Party):
Alice Kongsted, University of Southern Denmark

Tracking Information
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
 (submitted: April 16, 2019)
  • Brief Illness Perceptions Questionnaire (B-IPQ) [ Time Frame: 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.
  • Fear Avoidance Beliefs Questionnaire (FABQ) [ Time Frame: 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) [ Time Frame: 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)
  • Quality of Life (General health) [ Time Frame: 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 (Social functioning) [ Time Frame: Change from baseline to 12 months ]
    The 36-Item Short Form Health Survey (SF-36) subdomain social functioning, transformed score 0-100
  • Quality of Life (Mental functioning) [ Time Frame: Change from baseline to 12 months ]
    The 36-Item Short Form Health Survey (SF-36) subdomain mental functioning, transformed score 0-100
  • General Health [ Time Frame: Change from baseline to 12 months ]
    Health thermometer from Eq-5D, score 0= worst imaginable to 100= best imaginable
  • Health care visits primary care [ Time Frame: During 12 months after participation ]
    Number of primary care visits from national registries
  • Health care visits hospital [ Time Frame: During 12 months after participation ]
    Number of hospital visits due to LBP from national registries
  • Imaging [ Time Frame: During 12 months after participation ]
    x-rays, MRI and CT-scans of lower back from national registries
  • Pain medication [ Time Frame: During 12 months after participation ]
    Prescriptions of pain medication from national registries
Original Primary Outcome Measures
 (submitted: June 15, 2018)
  • Brief Illness Perceptions Questionnaire (B-IPQ) [ Time Frame: 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.
  • Fear Avoidance Beliefs Questionnaire (FABQ) [ Time Frame: 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) [ Time Frame: 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)
  • Quality of Life [ Time Frame: Change from baseline to 12 months ]
    The 36-Item Short Form Health Survey (SF-36) subdomains of general health, social functioning, mental health
  • Health Care Utilisation [ Time Frame: During 12 months after participation ]
    Primary care visits, hospital visits due to LBP, imaging for LBP, prescriptions for pain medication from national registries
Change History
Current Secondary Outcome Measures
 (submitted: April 16, 2019)
  • Confidence with exercises [ Time Frame: Change from baseline to 3 months ]
    How confident are you in performing exercises in a beneficial way?' (0-10 scale from 'not confident at all' to 'absolutely confident')
  • Self-assessed physical capacity [ Time Frame: Change from baseline to 3 months ]
    Self-assessed physical fitness visual analogue scales on perceived strength, endurance, flexibility, balance, and moving unhindered as compared with that of other people of the same age and sex. Each item is scored on a 9-point scale (1 = poor; 5 = average; 9 = super). Each item is treated as one subscale
  • Satisfaction with care [ Time Frame: 3 months ]
    Overall satisfaction with care (5-point Likert scale; 0 = Not at all satisfied, 5 = Extremely satisfied)
  • Patient reported harms or side effects [ Time Frame: 3 months ]
    Text description of any side effects or problems experienced in relation to the participation in GLA:D Back.
  • Oswestry Disability Index [ Time Frame: Change from baseline to 3, 6, 12 months ]
    Ten items, sum score 0 - 50 recalculated to 0-100 (0 = No disability; 100 = Maximum disability)
  • Pain Intensity [ Time Frame: Change from baseline to 3, 6, 12 months ]
    Numeric Rating Scale 0-10 for typical back pain last week (0 = no pain; 10 = worst imaginable pain)
  • Work ability [ Time Frame: During 12 months after participation ]
    Number of days off work after 1 month of absenteeism available from the 'DREAM' registry from the Danish Ministry of Employment
  • Brief Illness Perceptions Questionnaire (B-IPQ) [ Time Frame: Change from baseline to 6, 12 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.
  • Fear Avoidance Beliefs Questionnaire (FABQ) [ Time Frame: Change from baseline to 6, 12 months ]
    FABQ physical activity subscale (0 = no fear avoidance beliefs; 24 = highest possible fear avoidance)
  • The Arthritis Self-efficacy (ASES) [ Time Frame: Change from baseline to 3, 12 months ]
    ASES subscales of pain and other symptoms. Each item is scored on a 0 - 10 scale (0 = very uncertain; 10 = very certain)
  • Quality of Life (General Health) [ Time Frame: Proportions in response categories baseline to 3, 6 months ]
    The 36-Item Short Form Health Survey (SF-36 item 1),5-point Likert scale
  • Quality of Life (Social functioning) [ Time Frame: Change from baseline to 3, 6 months ]
    The 36-Item Short Form Health Survey (SF-36) subdomains social functioning, transformed score 0-100
  • Quality of Life /Mental functioning) [ Time Frame: Change from baseline to 3, 6 months ]
    The 36-Item Short Form Health Survey (SF-36) subdomains of mental functioning, transformed score 0-100
Original Secondary Outcome Measures
 (submitted: June 15, 2018)
  • Confidence with exercises [ Time Frame: Change from baseline to 3 months ]
    How confident are you in performing exercises in a beneficial way?' (0-10 scale from 'not confident at all' to 'absolutely confident')
  • Self-assessed physical capacity [ Time Frame: Change from baseline to 3 months ]
    Self-assessed physical fitness visual analogue scales on perceived strength, endurance, flexibility, balance, and moving unhindered as compared with that of other people of the same age and sex. Each item is scored on a 9-point scale (1 = poor; 5 = average; 9 = super). Each item is treated as one subscale
  • Satisfaction [ Time Frame: 3 months ]
    Overall satisfaction with care (5-point Likert scale; 0 = Not at all satisfied, 5 = Extremely satisfied)
  • Patient reported harms or side effects [ Time Frame: 3 months ]
    Text description of any side effects or problems experienced in relation to the participation in GLA:D Back.
  • Oswestry Disability Index [ Time Frame: Change from baseline to 3, 6, 12 months ]
    Ten items, sum score 0 - 50 recalculated to 0-100 (0 = No disability; 100 = Maximum disability)
  • Pain Intensity [ Time Frame: Change from baseline to 3, 6, 12 months ]
    Numeric Rating Scale 0-10 for typical back pain last week (0 = no pain; 10 = worst imaginable pain) Numeric Rating Scale 0-10 for typical back pain last week (0 = no pain; 10 = worst imaginable pain)
  • Work ability [ Time Frame: During 12 months after participation ]
    Number of days off work after 1 month of absenteeism available from the 'DREAM' registry from the Danish Ministry of Employment
  • Brief Illness Perceptions Questionnaire (B-IPQ) [ Time Frame: Change from baseline to 6, 12 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.
  • Fear Avoidance Beliefs Questionnaire (FABQ) [ Time Frame: Change from baseline to 6, 12 months ]
    FABQ physical activity subscale (0 = no fear avoidance beliefs; 24 = highest possible fear avoidance)
  • The Arthritis Self-efficacy (ASES) [ Time Frame: Change from baseline to 3, 12 months ]
    ASES subscales of pain and other symptoms. Each item is scored on a 0 - 10 scale (0 = very uncertain; 10 = very certain)
  • Quality of Life [ Time Frame: Change from baseline to 3, 6 months ]
    The 36-Item Short Form Health Survey (SF-36) subdomains of general health, social
Current Other Pre-specified Outcome Measures
 (submitted: June 15, 2018)
  • The Pain Attitudes and Beliefs Scale for Physiotherapists (PABS-PT) [ Time Frame: Change from before course participation to 4 months ]
    Clinician reported 19-item scale. Two subscales: biomedical orientation and behavioural orientation are scored
  • Practitioner Confidence Scale (PCS) [ Time Frame: Change from before course participation to 4 months ]
    Clinician reported 4-item scale plus two items added to capture confidence about using a behavioral pain model
  • The Determinants of Implementation Behavior Questionnaire (DIBQ) [ Time Frame: Immediately after curse participation and 4 months ]
    Clinician level measure of the implementation process. Thirty-one items from the domains of knowledge, skills, beliefs about capability, beliefs about consequences, innovation, patients, intentions, organisation, social influences, social context, behavioural regulation, and innovation strategy
  • Adoption [ Time Frame: Within 6 months ]
    Proportion of clinicians participating in a GLA:D Back course that delivers the program
  • Patients participation [ Time Frame: 4 months ]
    Clinician reported proportion of invited patients who decide to participate
  • Patient compliance [ Time Frame: 3 months ]
    Proportion of patients enrolled in GLA:D Back that complete the program
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.

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.

Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
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.
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
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: June 15, 2018)
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

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Inge Ris Hansen, PhD +4565504715 iris@health.sdu.dk
Contact: Line Thomassen, MSc +4565509414 lthomassen@health.sdu.dk
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
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Alice Kongsted, University of Southern Denmark
Study Sponsor University of Southern Denmark
Collaborators Not Provided
Investigators
Principal Investigator: Alice Kongsted, PhD University of Southern Denmark
PRS Account University of Southern Denmark
Verification Date April 2019