Trial document




This trial has been registered retrospectively.
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  DRKS00014664

Trial Description

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Title

Evaluation: Development and Implementation of a multimodal, cross-sectoral and cross-provider based care concept for major amputation

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Trial Acronym

MSTVK

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URL of the Trial

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Brief Summary in Lay Language

The study accompanies the impelementation of a care concept for people after a leg Amputation.

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Brief Summary in Scientific Language

In Germany approximately 60.000 lower extremity amputations are performed annually. The major amputation is a stressful procedure, which presents a lot of challenges for the patients’ social rehabilitation and their ability to return to work. The current care chain, after a leg-amputation, doesn’t meet the specific needs of the affected people. The multimodal, cross-sector, cross-provider based care concept provides a solution approach, that tackles this healthcare gap. The study examines, if the affected people receive and experience a better professional support, and if there is a sustained improvement in care and treatment.
The study uses a mixed-methods approach. In order to investigate the leading questions questionnaire data will be collected and additional qualitative interviews will be conducted with care-managers, patience and professional stakeholders. The primary outcome is the physical functioning. Secondary outcomes measures include social participation, work-ability, health-related quality of life, mobility, pain, anxiety and depression, as well as satisfaction with prosthetic care.
To achieve an unbiased estimation of the treatment effect, we will compare participants of the intervention with similar persons who did not participate in the innovative care concept. (propensity score matching)

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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

  •   DRKS00014664
  •   2018/09/27
  •   [---]*
  •   yes
  •   Approved
  •   18-036, Ethik-Kommission Universität zu Lübeck Medizinische Fakultät des Universitätsklinikums Schleswig-Holstein
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Secondary IDs

  •   U1111-1212-7780 
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Health Condition or Problem studied

  •   Z89 -  Acquired absence of limb
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Interventions/Observational Groups

  •   People in study arm 1 (intervention) will already be accompanied by a care manager during their acute phase in hospital, who supports the patients and coordinates the treatment procedures. The care-manager organizes the direct transfer to the ambulatory rehabilitative complex treatment at the Clinic for Rehabilitation Medicine at Hannover Medical School, during the 4 to 8 weeks interim phase. The main aim being to establish a wound situation of the stump, that allows a prosthetic fitting and thereby prepares the patient for the follow-up rehabilitation.
    The follow-up rehabilitation is based on a clinical pathway, which will be established together with the cooperating Rehabilitation Clinics. After the 3- to 6-week follow-up rehabilitation the patience will receive additional aftercare from a regional network. The network will include general practitioners, medical specialists, physiotherapy and ergotherapie practices, orthopedic technicians, wound managers, sports clubs, information platforms, psychologists, rehabilitation physicians and casemanager from the german pension insurance. All the included partners must account for expert knowledge in the field of treatment and care of leg amputees and furthermore be in direct exchange with one another.
    The integration of the leg amputees into the regional network shall ensure a life-long aftercare and reduce any complications concerning the stump and prosthetic care.
  •   People in study arm 2 (control condition) will receive usual care and no further/ addiotional support after the amputation.
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Characteristics

  •   Interventional
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  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   Control group receives no treatment
  •   Other
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Primary outcome is the physical functioning. It will be measured at four different moments during the questionnaire (t1= before rehabilitation, t2= after rehabilitation, t3= 6 month after amputation, t4= 12 month after amputation) using the scale "physical functioning".

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Secondary Outcome

The following secondary outcomes will be assessed by questionnaire before follow-up rehabilitation, at the end of rehabilitation and at 6-month follow-up and 12-month follow-up: social participation (IMET), work-ability (WAI), health-related quality of life (COPSOQ), mobility, pain (GCPS), anxiety and depression (PHQ-4), as well as satisfaction with prosthetic care (ZUF-8).

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
  • Medical Center 
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Recruitment

  •   Actual
  •   2018/05/30
  •   48
  •   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

Major-Amputation (OPS 5-864.0 bis 5-865.3) on one of the lower limbs, able to walk before amputation

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Exclusion Criteria

double-sided amputation; amputation performed outside of Germany

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Addresses

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    • Klinik für Rehabilitationsmedizin, Medizinische Hochschule Hannover
    • Mr.  Prof. Dr. med.  Christoph  Gutenbrunner 
    • Carl-Neuberg-Straße 1
    • 30625  Hannover
    • Germany
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    • Universität zu LübeckInstitut für Sozialmedizin und EpidemiologieArbeitsgruppe Rehabilitation & Arbeit
    • Mr.  Prof. Dr.  Matthias  Bethge 
    • Ratzeburger Allee 160
    • 23562  Lübeck
    • Germany
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    • Universität zu LübeckInstitut für SozialmedizinArbeitsgruppe Rehabilitation & Arbeit
    • Ms.  Mag. rer. nat.  Stella  Lemke 
    • Ratzeburger Allee 160
    • 23562  Lübeck
    • Germany
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Sources of Monetary or Material Support

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    • Innovationsausschuss beim Gemeinsamen Bundesausschuss
    • Wegelystraße 8
    • 10623  Berlin
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

  •   positives Ethikvotum MSTVK
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* This entry means the parameter is not applicable or has not been set.