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Non-interventional Observational Study on WHO-5 Questionnaire Application in Parkinson's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00752388
Recruitment Status : Completed
First Posted : September 15, 2008
Last Update Posted : November 19, 2013
Sponsor:
Information provided by:
Boehringer Ingelheim

Tracking Information
First Submitted Date September 12, 2008
First Posted Date September 15, 2008
Last Update Posted Date November 19, 2013
Study Start Date November 2008
Actual Primary Completion Date November 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 18, 2013)
Prevalence of patients with depressive symptoms (based on WHO-5 and MDI) in total and in subgroups [ Time Frame: day 1 ]
Original Primary Outcome Measures
 (submitted: September 12, 2008)
To assess the predictive value of sequentially administration of the WHO 5 and MDI scales for the clinical management of PD patients [ Time Frame: 1 day ]
Change History
Current Secondary Outcome Measures
 (submitted: November 18, 2013)
  • WHO-5 score and items [ Time Frame: day 1 ]
  • MDI score (for a subgroup of patients with WHO-5 score < 13 or any WHO-5 item rated with 0 or 1) [ Time Frame: day 1 ]
  • Correlation of WHO-5 and MDI (for a subgroup of patients with a WHO-5 score < 13 or any WHO-5 item rated with 0 or 1) in PD patients [ Time Frame: day 1 ]
  • Investigator assessment of the applicability of the WHO-5 for screening for depression in PD patients [ Time Frame: day 1 ]
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Non-interventional Observational Study on WHO-5 Questionnaire Application in Parkinson's Disease
Official Title Application of the WHO-5 Well-being Index (WHO-5) as a Screening Instrument for Depression in Parkinson's Disease
Brief Summary

To assess the predictive value of sequential administration of WHO-5 and MDI (Major Depression Inventory) for the clinical management of Parkinson Disease (PD) patients by

  • determination of the prevalence of depression in PD patients, based on MDI severity categories and the self-rating scale WHO-5, where poor well being was indicated.
  • exploration of influencing factors (PD status, therapeutic status) on the prevalence of MDI depression categories.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population resident physician
Condition Parkinson Disease
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: November 18, 2013)
1588
Original Estimated Enrollment
 (submitted: September 12, 2008)
4000
Study Completion Date Not Provided
Actual Primary Completion Date November 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  1. PD patients attending one of the participating neurologist practices during 2 fixed weeks in November 2008
  2. Idiopathic PD with or without fluctuations
  3. Male or female PD patients aged at least 30
  4. Ability to reliably complete self-rating scales (WHO-5, MDI) ), according to the physician's judgement.
  5. Written informed consent by the patient for study participation.

Exclusion Criteria:

  1. PD Patients who only attend the practice to get a prescription and are not seen by the doctor on that day
  2. Patients who are not able to understand the questionnaires (e.g. due to mental impairment or language problems).
Sex/Gender
Sexes Eligible for Study: All
Ages 30 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT00752388
Other Study ID Numbers 248.658
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Current Responsible Party Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
Original Responsible Party Same as current
Current Study Sponsor Boehringer Ingelheim
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
PRS Account Boehringer Ingelheim
Verification Date November 2013