Clinical Trials Directory

Trials / Completed

CompletedNCT03073044

Translation and Validation of BELA-p-K for QoL Evaluation in PD Patients

Italian Validation of the Belastungfragebogen Parkinson Kurzversion (BELA-P-K): a Disease-specific Questionnaire for Evaluation of the Subjective Perception of Quality of Life.

Status
Completed
Phase
Study type
Observational
Enrollment
100 (actual)
Sponsor
Ospedale Generale Di Zona Moriggia-Pelascini · Academic / Other
Sex
All
Age
Healthy volunteers
Accepted

Summary

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

Detailed description

In order to provide an appropriate endpoint for the assessment of the effectiveness of rehabilitation treatments on QoL of PD patients, in this study we translated and then validated the Belastungsfragebogen Parkinson kurzversion (BELA-P-k). This tool allows evaluating separately two crucial aspects: i) the loss of personal autonomy in activities of daily life and ii) the psychological and psychosocial impact of the disease. The BELA-P-k was translated from Dutch into Italian. Subsequently 102 patients with PD filled out the questionnaire. PD patients were also evaluated by using the Parkinson Disease Questionnaire -39 (PDQ39), the Unified Parkinson's Disease Rating Scale (UPDRS), the Mini Mental State Examination (MMSE) and the Frontal Assessment Battery (FAB) The internal consistency of the questionnaire was assessed by means of Cronbach's alpha coefficient. The discriminant validity was assessed by testing for differences between mean values for patients grouped according to Hoehn and Yahr stages. This analysis was carried out by a one-way analysis of variance. Finally, the construct validity was determined by assessing the relationship (Spearman rank correlation coefficient) between Bela-P-k and the PDQ39

Conditions

Interventions

TypeNameDescription
DIAGNOSTIC_TESTBELASTUNGSFRAGEBOGEN PARKINSON KURZVERSION (BELA-P-K)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

Timeline

Start date
2015-09-01
Primary completion
2016-09-01
Completion
2017-02-01
First posted
2017-03-08
Last updated
2017-03-08

Source: ClinicalTrials.gov record NCT03073044. Inclusion in this directory is not an endorsement.