Trial document




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  DRKS00012852

Trial Description

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Title

GP-based rehabilitation follow-up in chronic back pain

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Trial Acronym

HaReNa

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URL of the Trial

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Brief Summary in Lay Language

For patients with chronic back pain, participation in medical rehabilitation programs is reasonable, yet, as studies have shown, effects often fail to sustain. The project aims to integrate general practioners (GPs) in rehabilitation follow-up in order to secure the success. It is widely known that patients struggle to continue in their everyday life what they have learned during the rehabilitation program – thus, they need community-based support. Studies have shown that GPs are the most important contact person and that they have great interest in supporting rehabilitation follow-up.
Patients with chronic back pain in inpatient orthopedic rehabilitation are taught to use activity diaries in order to plan and document physical activities in their everyday life. After the inpatient rehabilitation, the GP accompanies the patient over 12 months, discussing the daily activities and obstacles based on the diaries. Appointments take place every two or three months. Additionally, medical assistans regurlarly contact the patients via telephone in order to support and motivate the patients to stick with their plans.
Effects are measured via questionnaires before and after the inpatient program and at the end of the follow-up.

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Brief Summary in Scientific Language

Implementation and evaluation of an innovative follow-up approach within GP-service. We will scrutinize 1) feasibility of implementation of stable cooperation structures between rehabilitation clinincs and GPs 2) long-term health effects of gp-based rehabilitation follow-up in patients with chronic back pain.
Thus, we will conduct an observational study (prospective, mixed-methods), focusing on two main themes:
1) Implementing structures of cooperation between rehabilitation clinics and GPs. Fesability and acceptance will be investigated based on the evaluation framework for complex interventions provided by the Medical Research Council.
2) Investigation of long-term health effects of gp-based rehabilitation follow-up (quantitative longitudinal study with three measuring time points.).

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00012852
  •   2017/08/10
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  •   yes
  •   Approved
  •   17-088, Ethik-Kommission Universität zu Lübeck Medizinische Fakultät des Universitätsklinikums Schleswig-Holstein
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Secondary IDs

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Health Condition or Problem studied

  •   M54 -  Dorsalgia
  •   M53 -  Other dorsopathies, not elsewhere classified
  •   M51 -  Other intervertebral disc disorders
  •   M42 -  Spinal osteochondrosis
  •   M43 -  Other deforming dorsopathies
  •   M47 -  Spondylosis
  •   M48 -  Other spondylopathies
  •   M96.1 -  Postlaminectomy syndrome, not elsewhere classified
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Interventions/Observational Groups

  •   Patients with chronic back pain in orthopedic inpatient Rehabilitation will receive gp-based rehabilitation follow-up and will answer questionnaires covering Patient-reported outcomes at three points in time
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Prognosis
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

1.) Participation (IMET - Index for measuring restrictions in participation, questionnaire) before rehabilitation and after 12 month.
2.) Functional ability in everyday life (FFbH-R, Hannover Functional Ability Questionnaire) before and after rehabilitation and after 12 month

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Secondary Outcome

patient-reported health outcomes (questionnaires: symptom checklist SCL-90-R, Gesundheitsbezogene Lebensqualität, short form health survey SF-36 (subscales vitality and mental health), depressive symptoms CES-D, subjective prognostic employment Scale SPE, physical activity and capacity in various life domains, single items), before and after Rehabilitation and after 12 month

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • other 
  • other 
  • other 
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Recruitment

  •   Actual
  •   2017/11/28
  •   176
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

patients with back pain

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Exclusion Criteria

patients in post acute rehabilitation, backsurgery within the past 6 month, general practioner unwilling to participate

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Addresses

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    • UKSH / Universität zu Lübeck Institut für Sozialmedizin und Epidemiologie FB 4 Rehabilitationsforschung
    • Ms.  PD Dr.  Ruth  Deck 
    • Ratzeburger Allee 160
    • 23562  Lübeck
    • Germany
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    • UKSH/ Universität zu Lübeck Institut für Sozialmedizin und Epidemiologie Fb 4 Rehabilitationsforschung
    • Ms.  PD Dr.  Ruth  Deck 
    • Ratzeburger Allee 160
    • 23562  Lübeck
    • Germany
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    • Universität zu LübeckInstitut für Sozialmedizin und Epidemiologie Fb 4 Rehabilitationsforschung
    • Ms.  PD Dr.  Ruth  Deck 
    • Ratzeburger Allee 160
    • 23562  Lübeck
    • Germany
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Sources of Monetary or Material Support

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    • Innovationsfonds beim Gemeinsamen Bundesausschuss
    • Wegelystr. 8
    • 10623  Berlin
    • Germany
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Status

  •   Recruiting complete, follow-up continuing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.