NCT02141568

Brief Summary

The purpose of this study is to check the medical efficacy and economic benefits of multidisciplinary care in patients with unexplained medical complaints and consume medical services frequently.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

First Submitted

Initial submission to the registry

May 15, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 19, 2014

Completed
1.6 years until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 26, 2019

Completed
Last Updated

April 5, 2019

Status Verified

March 1, 2019

Enrollment Period

1 year

First QC Date

May 15, 2014

Last Update Submit

April 3, 2019

Conditions

Keywords

Cost-effectiveUnexplained Medical SymptomsFrequent Attenders

Outcome Measures

Primary Outcomes (1)

  • Health Related Quality of Life

    Changes in the Short Form 36 Health Survey (SF-36)

    6 months

Secondary Outcomes (8)

  • Cost-effectiveness

    12 months

  • Anxiety

    6 months

  • Depression

    6 months

  • Catastrophization

    6 months

  • Locus of Control

    6 months

  • +3 more secondary outcomes

Study Arms (2)

Intervention Group for Prospective Study

EXPERIMENTAL

Intervention: Medical and psychological treatment at the Soroka UMC "functional neurology" outpatient clinic. Treatment will be conducted by a multidisciplinary staff. Patients will undergo an initial meeting with a neurologist and afterwards will be directed to other members of the team (psychologist, physical therapist) on a case by case basis.

Other: Medical and Psychological treatment

No Intervention

NO INTERVENTION

Patient records will be analyzed via Clalit Health Service electronic records. No additional intervention will occur

Interventions

Medical and psychological treatment by the staff of the "functional neurology" clinic at Soroka UMC. This treatment will include an initial visit to the staff neurologist and further multidisciplinary treatment as per his decision (the team includes a psychologist and a physical therapist).

Intervention Group for Prospective Study

Eligibility Criteria

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

You may qualify if:

  • Men or women
  • Age 18 or higher
  • Treated at the Functional Neurology clinic at Soroka UMC

You may not qualify if:

  • patients with chronic illness such as cancer, dialysis patients, or any other severe identified illness
  • patients who do not speak Hebrew
  • bedridden patients
  • Schizophrenia, dementia and other severe mental illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Soroka University Medical Center

Beersheba, 84101, Israel

Location

MeSH Terms

Conditions

NeurastheniaChronic PainHeadache Disorders

Condition Hierarchy (Ancestors)

Somatoform DisordersMental DisordersPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Yacov Ezra, MD

    Soroka University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 15, 2014

First Posted

May 19, 2014

Study Start

January 1, 2016

Primary Completion

January 1, 2017

Study Completion

February 26, 2019

Last Updated

April 5, 2019

Record last verified: 2019-03

Locations