Trial document




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  DRKS00008068

Trial Description

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Title

SMS-based telemedical after-care of patients of Jena University Hospital's Pain Day Clinic

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Aim of our study is to compare an intervention in current patients of our pain day clinic with a historic patient population. We were able to show a significant improvement of pain intensity, impairments caused by pain, depression and need for anagesics during a 4-week lasting semi-residential multi-modal pain therapy. These improvements lasted up to a 2-days follow-up phase (“booster”) and in some cases even continued to improve. However, after the multi-modal interdisciplinary care was over and patients returned to general patient care (assessed six months after end of multi-modal pain therapy), a deterioration of treatment outcome took place.

Main objective of the planned study is to assess feasibility of a telemedical intervention after end of contact with the interdisciplinary treatment team that aims at slowing down this fading away of achieved therapy effects, or in the best case, to stop this tendency.

The intervention population will be generated from patients who have undergone the 2-days follow up phase. Intervention is planned to extend over a period of 4 weeks. The population to be compared is patients who had been treated before the intervention was introduced.

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Brief Summary in Scientific Language

Intervention

Our objective is to prepare the first steps for development of a pain therapy app. At first, this will be done in the framework of a doctoral thesis. This pilot study aims at testing feasibility of a mobile phone based therapy support subsequent to treatment in our pain day clinic. As a result, we hope that learned coping strategies for chronic pain will be steadied and stabilized.

To this end, we want to use text messages, so called SMS, that can be received by any mobile phone. These SMS will be written by a multi-professional team (sports physician, physiotherapy physician, psychological psychotherapist, pain therapist, general practioner) according to the pain day clinic’s concept. The SMS convey educational, motivational and reminding messages. Over a period of 4 weeks, on 5 days per week (Monday to Friday) these supporting SMS are sent out. For the detailed wording, please see the enclosed SMS-protocol.

On 4 days each week, patients get an additional SMS asking them to answer some short questions („Feedback SMS). For this, patients have to answer questions with a number from 0 – 10, according to a numeric rating scale. Again, please see the en-closed SMS-protocol for details. However, the SMS does not replace direct communica-tion with us or with other medical staff in charge. This intervention study does not affect parallel care by GPs or specialists, including pain therapists.

Within this study, we will ask the patients regularly to answer questionnaires in writing (see enclosure). Patients get the first questionnaire after the 4-week SMS phase is over. An additional questionnaire is sent out after around 3 months. The second questionnaire corresponds to the tool that is routinely applied after 6 months. This makes a comparison with a historic patient population possible, that got standard therapy but no intervention. In addition, course of outcome parameters over time is to be assessed in the intervention group.

Methods

24 patients from the interdisciplinary pain day clinic at Jena University Hospital are to be examined. It is a gender and age mixed patient population with different types of chronic pain that fulfill inclusion criteria for multi-modal pain therapy (presence of the diagnosis F45.41 – chronic pain disorder with somatic and psychic factors, unsuccessful mono-disciplinary pre-treatment, indication for semi-residential hospital stay). All patients receive the normal standardized 4-weeks semi-residential multi-modal pain therapy, and after 2 – 3 months a 2-days boosting. Directly following this, the telemedical intervention over 4 weeks starts.

Further inclusion criteria are written informed consent by the patient, existence of a mo-bile phone, ability to receive and send SMS, sufficient German language skills and age of 18 years or older. Exclusion criteria are any diseases that can lead to a cognitive im-pairment, repeated participation of the day clinic pain program, a planned operation, in-patient treatment or traveling during the examination period.

From Monday to Friday, standardized SMS containing texts according to the day clinic program are sent out. On 4 days, the patients get additional Feedback-SMS that require numeric rating scale based answers.
Outcome parameters are assessed by mail in the framework of a routine survey around 6 months after end of the semi-residential treatment (2 months after end of the telemedical intervention). In addition, patients get a questionnaire that asks for acceptance, technical problems and subjective assessment of the intervention.


Final remarks

Interventions in the area of „mHealth“ (e.g. apps for tracking or step counting as well as logs, etc.) have already been examined in other diseases. Social support via tele medi-cine has been applied in pain therapy as well as in after-care of psychiatric patients, but often only single aspects (pain intensity, coping, catastrophizing, movement, reminders for drug intake or appointments) have been examined.

Our project stands out due to the fact that the telemedical support elements have been developed by a multi-professional team that is very experienced in multi-modal pain therapy. This enables us to expertly deal with many dimensions of pain and its after-care. Furthermore, no study or intervention has been done so far in Germany with this specific patient population of pain day clinic patients.

Main aspect of this pilot study is to test general feasibility and acceptance of a telemedi-cal intervention.

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Organizational Data

  •   DRKS00008068
  •   2015/05/05
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  •   yes
  •   Approved
  •   4383-03/15, Ethikkommission der Friedrich-Schiller-Universität Jena an der Medizinischen Fakultät
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Secondary IDs

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Health Condition or Problem studied

  •   F45.41 -  [generalization F45.4: Persistent somatoform pain disorder]
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Interventions/Observational Groups

  •   Patients after the 4-weeks semi-residential multi-modal pain therapy: directly following the booster follow-up (2-3 months after the pain therapy), patients get SMS on 5 days a week over a period of 4 weeks with educational, motivating and reminding messages. On 4 days a week, patients get an additional SMS, asking them to answer a short question.
  •   historic comparison patient group, i.e. patients who underwent the 4-weeks semi-residential multimodal pain therapy including the 2-days booster follow-up, but who did not receive SMS-based aftercare.
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Characteristics

  •   Interventional
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  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   Historical
  •   Supportive care
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

Feasibility test of a telemedical intervention and its acceptance by the patient population. Acceptance is assessed by use of a patient questionnaire that will be completed 2 months after end of the telemedical intervention.

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Secondary Outcome

2. change of pain intensity (assessed by use of BPI)
3. change of pain-caused impairments (assessed by use of Korff-scale)
4. change of health-related quality of life (assessed by use of SF-12)

Time of assessment: 4 weeks and 2 months after end of intervention

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2015/04/20
  •   48
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

Intervention group:
- meeting inclusion criteria for multi-modal pain therapy
- informed consent
- availability of a mobile phone
- ability to read and write SMS
- knowledge of German language.

Comparison group:
- meeting inclusion criteria for multi-modal pain therapy
- informed consent

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Exclusion Criteria

- not meeting one or more of the inclusion criteria

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Addresses

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    • Universitätsklinikum Jena
    • Bachstraße 18
    • 07740  Jena
    • Germany
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    • Universitätsklinikum JenaKlinik für Anästhesiologie und IntensivmedizinSection Schmerztherapie
    • Mr.  Kevean  Mönchgesang 
    • Erlanger Allee 101
    • 07747  Jena
    • Germany
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    • Universitätsklinikum JenaKlinik für Anästhesiologie und IntensivmedizinSection Schmerztherapie
    • Mr.  Kevean  Mönchgesang 
    • Erlanger Allee 101
    • 07747  Jena
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum JenaKlinik für Anästhesiologie und IntensivmedizinSection Schmerztherapie
    • Erlanger Allee 101
    • 07747  Jena
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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