NCT03073044

Brief Summary

The BELA-P-k was translated from Dutch into Italian. Subsequently 102 patients with PD filled out the questionnaire

Trial Health

100
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2015

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, 2015

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

February 22, 2017

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 8, 2017

Completed
Last Updated

March 8, 2017

Status Verified

March 1, 2017

Enrollment Period

1 year

First QC Date

February 22, 2017

Last Update Submit

March 2, 2017

Conditions

Keywords

Quality of lifepsychosocial and psychological problems

Outcome Measures

Primary Outcomes (1)

  • Bela-p-K

    questionnaire for QoL evaluation

    15 minuts

Interventions

we proposed the translation and validation of Bela-p-K, a questionnaire that evaluates the Quality of Life in parkinsonian patients. we applied the method of translation and back-translation at dutch version of questionnaire. after, we evaluated 103 PD patients with Bela-p-K and PDQ39. The internal consistency of questionnaire was analyzed calculating alpha-Chronbach. We also evaluated the construct validity correlating Bela-p-K and PDQ39

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with idiopathic Parkinson Disease

You may qualify if:

  • Parkinson's Disease

You may not qualify if:

  • any focal brain lesion detected in brain imaging studies (CT or MRI) performed in the previous twelve months;
  • other chronic diseases with a known impact in QoL.
  • MMSE \< 24

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Spliethoff-Kamminga NG, Zwinderman AH, Springer MP, Roos RA. Psychosocial problems in Parkinson's disease: evaluation of a disease-specific questionnaire. Mov Disord. 2003 May;18(5):503-9. doi: 10.1002/mds.10388.

    PMID: 12722163BACKGROUND
  • Ringendahl H, Werheid K, Leplow B, Ellgring H, Annecke R, Emmans D. [Recommendations for standarsized psychological diagnosis in Parkinson patients]. Nervenarzt. 2000 Dec;71(12):946-54. doi: 10.1007/s001150050691. German.

    PMID: 11139990BACKGROUND
  • Ortelli P, Maestri R, Zarucchi M, Cian V, Urso E, Giacomello F, Ferrazzoli D, Frazzitta G. Italian validation of the Belastungsfragebogen Parkinson kurzversion (BELA-P-k): a disease-specific questionnaire for evaluation of the subjective perception of quality of life in parkinson's disease. J Clin Mov Disord. 2017 Jul 25;4:12. doi: 10.1186/s40734-017-0059-x. eCollection 2017.

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dipartimento di riabilitazione malattia di Parkinson, Disturbi del movimento e Cerebrolesioni Acquisite

Study Record Dates

First Submitted

February 22, 2017

First Posted

March 8, 2017

Study Start

September 1, 2015

Primary Completion

September 1, 2016

Study Completion

February 1, 2017

Last Updated

March 8, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share