Trial document




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  DRKS00015230

Trial Description

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Title

Socio-medical aftercare for severely chronified pediatric pain patients: A randomized controlled multicenter study

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Trial Acronym

SCHMERZ-NETZ

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URL of the Trial

[---]*

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Brief Summary in Lay Language

For children and adolescents with severe chronic pain, multimodal interdisciplinary stationary pain therapy is the most effective form of treatment. After the dismissal, however, patients and their families go into a critical phase and have to apply the lessons learned in the clinic also in their everyday life. The aim of this intervention study is to transfer the concept of social medical aftercare to this group of patients: after dismissal, the family will be accompanied by a case manager/social worker for another 3 to 6 months. The primary goal here is help for self-help. It is to be demonstrated that this form of aftercare is effective for young pain patients: it is expected that patients who receive aftercare will go better one year after the inpatient treatment than the patients who do not receive it.

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Brief Summary in Scientific Language

According to conservative estimates, 350,000 children and adolescents in Germany (3% to 5% of this age group) suffer from severely debilitating, disabling chronic pain. The currently best therapy for severely debilitating, disabling chronic pain is an interdisciplinary multi-modal pain therapy. In Germany there are currently three specialised children's pain centres (Datteln, Stuttgart and Augsburg), all of which work according to the same interdisciplinary multi-modal therapy approach and offer a three-week stationary therapy. However, there is a critical phase for all patients after stationary dismissal, which is crucial for the long-term treatment process. The stationary pain therapy is short and intensive, the patients learn a lot of new things, which they then have to transfer into their everyday life and receive a multitude of recommendations for further outpatient measures. A personalized social medical aftercare (SMN), which is specifically tailored to the needs of patients, is at this critical stage to ensure a smooth return to everyday life. SMN offers above all support in the implementation and coordination of prescribed services and outpatient offers. In the treatment of premature and risk-born people, SMN has already proved effective in a prospective randomized study, the burden of the affected children and families as well as the number of stationary hospital stays and outpatient emergency treatments. (Porz et al., 2006). In addition, Metaanalysis has demonstrated that adherence supportive interventions on children and adolescents with chronic diseases improve their self-management, and also reduce the severity of the disease Leads. Although SMN is intended for chronically ill or seriously ill children and adolescents, it is not yet treated for the group of patients with severely debilitating, disabling chronic pain that is inpatiently quality-assured (OPS 8-918) are carried out. However, it is to be supposed that this group of patients would also benefit greatly from a SMN. For the evaluation of the new socio-medical aftercare programme, a multicenter randomly controlled study design is carried out with five measuring points (stationary reception, stationary discharge, 3-, 6-and 12-month follow-up). Both study groups receive the usual aftercare, since pain therapy with the current aftercare is already effective for 60% of patients and no patient is to be deprived of effective therapy. The intervention group also receives SMN pain. The children and adolescents are recruited consecutively at a stationary reception on the pain station of one of the three participating clinics (vesting children and Youth Clinic Datteln, Olgaspital Stuttgart or Klinikum Augsburg). Presentation is complex persistent pain. In addition to the patient, the parents are also asked to attend studies. SMN pain is expected to result in a better outcome in the medium term. Another data source is the routine data of the participating health insurance companies. From this data pool, the participants are used routinely in the present agreement. This includes billing data from stationary stays, outpatient medical contacts, outpatient diagnoses, prescription data and medicines ordinances (Heilmittelverordnungen) and resource regulations (Hilfsmittelverordnungen). Data are extracted 3 years before inpatient recording and data 3 years after inpatient reception/release.

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Organizational Data

  •   DRKS00015230
  •   2018/08/06
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  •   yes
  •   Approved
  •   89/2018, Ethik-Kommission der Universität Witten/Herdecke
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Secondary IDs

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Health Condition or Problem studied

  •   F45.4 -  Persistent somatoform pain disorder
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Interventions/Observational Groups

  •   Pediatric pain patients after stationary dismissal with usual aftercare (TAU).
  •   Pediatric pain patients after stationary dismissal with social-medical aftercare (SMN)
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Chronic pain grading: it is assumed that the patients of SMN pain have a lower pain severity 12 months after the stationary release, i.e. are in lower CPG levels than the control group.

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Secondary Outcome

Secondary endpoints: The following hypotheses are formulated for the secondary endpoints:
• Pain Characteristics: Children and adolescents in the intervention group SMN pain Show to all follow-ups a greater reduction in pain intensity, pain-related Impairment in everyday life and pain-related school days as patients of the control group.
• Emotional impairment: Children and adolescents in the intervention group show a greater reduction of anxiety and depression in all follow-ups and a greater increase in the quality of life than patients in the control group.
• Therapy adherence: Children and adolescents in the intervention group have implemented more frequent therapy recommendations for all follow-ups than patients in the control group.
• Therapy Satisfaction: Children and adolescents in the intervention group show greater treatment satisfaction for all follow-ups than patients in the control group.
• Use of health services: in the year after inpatient treatment, patients in the intervention group are more likely to take advantage of the health benefits recommended when dismissed than patients in the control group.
• Routine data: In the year following the inpatient treatment, patients of the two conditions of study cause comparable costs. In subsequent years, the costs incurred by the intervention group are below those of the control group.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
  • Medical Center 
  • Medical Center 
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Recruitment

  •   Planned
  •   2018/09/01
  •   394
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   8   Years
  •   17   Years
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Additional Inclusion Criteria

1. Presentation is complex persistent pain.
2. An age-appropriate German language and reading comprehension to answer the questionnaires
3. Initial admission to pain station during the study period
4. Consent for the participation of the student in custody and the patient

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Exclusion Criteria

No consent to participate

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Addresses

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    • Universität Witten/Herdecke
    • 58448   Witten
    • Germany
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    • Vestische Kinder- und Jugendklinik Datteln Universität Witten/ HerdeckeDeutsches Kinderschmerzzentrum
    • Ms.  Meltem  Dogan 
    • Dr.-Friedrich-Steiner-Straße 5
    • 45711  Datteln
    • Germany
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    • Vestische Kinder- und JugendklinikUniversität Witten/HerdeckeDeutsches Kinderschmerzzentrum
    • Ms.  Meltem  Dogan 
    • Dr.-Friedrich-Steiner-Str. 5
    • 45711  Datteln
    • Germany
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Sources of Monetary or Material Support

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    • Innovationsausschuss beim Gemeinsamen Bundesausschuss
    • 10623   Berlin
    • Germany
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Status

  •   Recruiting planned
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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.