NCT02897622

Brief Summary

Patients with severe and enduring eating disorders (SEED) are seriously ill and have a low quality of life. In 2014, a special unit based on case management (CM), for patients with SEED (the Eira unit) was started at Stockholm Centre for Eating Disorders, Sweden. Eating disorder is a serious illness that creates a great deal of suffering. Most patients who undergo specialized eating disorder treatment will be healthy, but a small percentage of the patients develop a SEED. SEED patient have gone through numerous of treatments and has been to several specialists units for years as well as they has completed many different therapies without getting fee from the eating disorder (ED). Due to the long term sick in ED the SEED patient is often alone and has difficulties to cope with everyday life situations. SEED patients are a vulnerable patient population with a great suffering and poverty to release the identity of the ED. However, no previous study is done in which patients with SEED themselves describe their own theory about why they are still ill and how specialized eating disorder care has affected them. In the ED field, there is a growing consensus that treatment of patients with SEED needs to be multi-professional, with a focus on improving the patients' social situation, minimizing medical complications, and enhancing quality of life and independence, rather than focusing one-sided on symptom reduction. Is case management a way to help the SEED patients witness a better quality of life? Besides the personal suffering of patients and their families, SEED is also associated with high costs for health care and for society in general.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

August 12, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 13, 2016

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed
Last Updated

September 13, 2016

Status Verified

September 1, 2016

Enrollment Period

6.8 years

First QC Date

August 12, 2016

Last Update Submit

September 7, 2016

Conditions

Keywords

Eating disorderssevere and enduringquality of lifecase management

Outcome Measures

Primary Outcomes (1)

  • Patients experience of specialized eating disorder care

    By semi structured interviews

    up to 5 years

Secondary Outcomes (2)

  • Quality of life

    up to 5 years

  • Cost-effectiveness

    up to 5 years

Study Arms (1)

Case management

OTHER

Case management

Other: Case management

Interventions

Case management by Eira unit

Case management

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Primary diagnosis: eating disorder according to DSM IV (Diagnostic and statistical manual of mental disorders fourth edition) Criteria based on diagnostic interview
  • Illness duration of ED \>10
  • Participated in at least three failed specialized eating disorder treatments
  • Written informed consent
  • Having the mental capacity to make provide informed consent to research participation
  • Somatically stable

You may not qualify if:

  • Somatically unstable

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maja Molin

Stockholm, Sweden

RECRUITING

Related Publications (1)

  • Molin M, von Hausswolff-Juhlin Y, Norring C, Hagberg L, Gustafsson SA. Case management at an outpatient unit for severe and enduring eating disorder patients at Stockholm Centre for Eating Disorders- a study protocol. J Eat Disord. 2016 Oct 26;4:24. doi: 10.1186/s40337-016-0121-3. eCollection 2016.

MeSH Terms

Conditions

Feeding and Eating Disorders

Interventions

Case Management

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Intervention Hierarchy (Ancestors)

Patient Care PlanningComprehensive Health CarePatient Care ManagementHealth Services Administration

Study Officials

  • Yvonne von Hausswolff-Juhlin, MdPhD

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Maja Molin, PhD stud

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associated professor

Study Record Dates

First Submitted

August 12, 2016

First Posted

September 13, 2016

Study Start

April 1, 2014

Primary Completion

January 1, 2021

Study Completion

January 1, 2021

Last Updated

September 13, 2016

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will not share

Locations