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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03501329
Other study ID # UFL-03-18-0170
Secondary ID
Status Completed
Phase
First received March 21, 2018
Last updated April 16, 2018
Start date January 1, 2017
Est. completion date November 30, 2017

Study information

Verified date April 2018
Source Psychiatric Research Unit, Region Zealand, Denmark
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

Patient reported quality of life was measured using the WHO-5 Well-Being Index in a group of outpatients in the Community Psychiatry in Holbaek, Denmark.

Methods

The first and last answer were compared and significance of change in various subgroups of patients was estimated using the PSPP statistical program.


Description:

Investigation of the change of The WHO-5 Wellbeing Index during a year in a Community Psychiatry in Denmark.

Introduction

In the Community Psychiatry of the town Holbaek part of Region West of The Region Sjaelland in eastern Denmark the WHO-5 Well-Being Index has for 5 years been used in order to obtain the patients personal evaluation of their actual quality of life. That has given the possibility of following changes during the treatment. The questionnaire is easy to understand and to use as part of a consultation. The patients will answer the 5 questions in a few minutes. The WHO-5 questionnaire is thoroughly evaluated internationally and described and used in many clinical situations also outside of psychiatry and fulfill measures of psychometric quality. With this work the intention was to try to answer often critical questions from our administration and from the press and in the society. There was no funding for the work.


Recruitment information / eligibility

Status Completed
Enrollment 204
Est. completion date November 30, 2017
Est. primary completion date November 30, 2017
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- all patients able and willing to participate

Exclusion Criteria:

- patients with mental conditions making them unable to answer simple questions about their daily life (in general severe psychosis and severe organic mental disorders)

Study Design


Related Conditions & MeSH terms


Intervention

Combination Product:
Biological,Psychological and Social support


Locations

Country Name City State
Denmark Psykiatrisk Forskningsenhed Slagelse Region Zealand

Sponsors (1)

Lead Sponsor Collaborator
Psychiatric Research Unit, Region Zealand, Denmark

Country where clinical trial is conducted

Denmark, 

References & Publications (1)

Topp CW, Østergaard SD, Søndergaard S, Bech P. The WHO-5 Well-Being Index: a systematic review of the literature. Psychother Psychosom. 2015;84(3):167-76. doi: 10.1159/000376585. Epub 2015 Mar 28. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Change in The WHO-5 Well-Being Index This is a Patient Reported Outcome Measure (PROM) for studying changes in the Well-Being Index during ongoing treatment. In many cases it was not possible to maintain the patients in the study for the intended time period and it was found necessary to accept the latest evaluation as the final measurement of change. It will be possible to report the observation time in months for each single case and to report the median of these periods of observation. The Time Frame was from the beginning of the participation in the study (baseline) and at the completion of the study participation (approximately 1 year).
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