NCT02246283

Brief Summary

The elderly demographic is on the rise - and this includes elderly living with schizophrenia. Yet very little is known about their lives, how they cope with their condition and how it develops over time. Research in this patient-group is sparse; overall there seem to be a tendency for elderly patients to manifest fewer psychotic symptoms and experiencing an increase in the psychological quality of life with older age. Opinions are divided on the degree and extent to which this tendency reflects remission and/or recovery in older patients. In order to identify factors associated with a positive outcome we:

  • Investigate the course and the outcomes of the illness over the lifespan, as well as the life course and outcomes.
  • Investigate the current status of mental and physical health, quality of life as well as functional competence of elderly (55+ yr) with schizophrenia. Also the investigators \- Compare the trajectory and prognosis of schizophrenia (a chronic mental illness) with type 1 diabetes (a chronic somatic illness). This study will yield vital insights into how schizophrenia develops over time, isolating factors that determine how well patients fare. The perspective is to advance knowledge of elderly with schizophrenia with a view to optimizing and increasing the effectiveness of the interventions offered to this group.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10,404

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

September 1, 2013

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

September 17, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 22, 2014

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

July 17, 2018

Status Verified

July 1, 2018

Enrollment Period

2 years

First QC Date

September 17, 2014

Last Update Submit

July 16, 2018

Conditions

Keywords

schizophreniaelderlylifelongquality of liferegisterquestionaire

Outcome Measures

Primary Outcomes (1)

  • Ageing with schizophrenia

    Prognosis measured by use of healthcare system, use of medicine, co-morbidity, mortality, causes of mortality, and socio-demographic data, including highest level of education, years of employment/un-employment, use of health- and welfare services.

    up to 45 years

Secondary Outcomes (2)

  • Quality of life

    1 month

  • Remission

    6 months

Eligibility Criteria

Age55 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Registry study: A nationwide register cohort study (1970-79) identifying psychiatric admissions (aged 18-40), who were registered with a schizophrenia diagnosis. Several Danish registers are applied. Interview study: A cross-sectional survey where 150 randomly drawn surviving members of the register cohort resident in the Region of Southern Denmark will be interviewed on the basis of internationally validated assessment tools.

You may qualify if:

  • Initial schizophrenia diagnosis between the ages 18-40 (both incl) in the period 1970-1979 (both incl) Interview study: Residence in Region of Southern Denmark

You may not qualify if:

  • Interview study: Mental retardation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Unit of Psychiatry, Psychiatric Unit Odense - University function

Odense C, 5000, Denmark

Location

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Maria Brink, MD

    University of Southern Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 17, 2014

First Posted

September 22, 2014

Study Start

September 1, 2013

Primary Completion

September 1, 2015

Study Completion

December 1, 2017

Last Updated

July 17, 2018

Record last verified: 2018-07

Locations