The Effect of the german peer counselling program „Peers im Krankenhaus (PiK, engl. Clinical Peers) on amputations

Not Applicable

Recruiting

• Conditions: Z89; Amputations; Acquired absence of limb

• Registration Number: DRKS00026689
• Lead Sponsor: nfallkrankenhaus Berlin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-09-30
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 206

Inclusion Criteria

Men and women, aged from 18 to 70 years, regardless of their insurance status
- Acute amputation of a limb (single and multiple amputations, as well as first and subsequent amputations) or severe (i.e. post-traumatic) complications which make the preservation of the limb impossible or unjustifiable. This includes in particular:
*primary amputations of one or more extremities due to the rescue from a danger zone
*Primary amputation of one or more extremities due to an injury pattern or damage which, according to current medical knowledge, offers no prospect of reconstruction or preservation
*unsuccessful attempts tor preserve extremities despite all available surgical and adjuvant actions (e.g. repeated failure of flap covers, infections, non-recoverable sensitive deficits
*despite multimodal therapy, uncontrollable post-traumatic or post-operative infections
- Despite of appropriate medical actions, a limb can not be used due to e.g. failure of recovery from a fracture, extensive nerve damage with loss of sensitivity, no robust flap care
- Written consent to participate in the study and readiness for a personal consultation with the peer on a regular basis.

Exclusion Criteria

- Participation in another interventional study
- Lack of agreement or willingness to peer consultation
- Presence of a psychiatric disease, in particular serious personality disorders of suicidal tendencies
- Lack of compliance
- Insufficient knowledge of the German language

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Health related quality of life, assassed with the physical and mental Scale of the SF-36 after 6Month

Secondary Outcome Measures

Name	Time	Method
Rehabilitation process, ability to work, as well as questionnaires depression, anxiety and stress (DASS), self-efficacy expectations (GSE), pain (TAPES-R) and body image (ABIS)