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

Completed

• Conditions: Parkinson Disease

• Registration Number: NCT03073044
• Lead Sponsor: Ospedale Generale Di Zona Moriggia-Pelascini

Brief 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

Study Timeline

• Study Start: 2015-09-01
• Primary Completion: 2016-09-01
• Study Completion: 2017-02-01
• Study First Submitted: 2017-02-22
• Status Verified: 2017-03
• Study First Submitted QC: 2017-03-02
• Last Update Submitted: 2017-03-02
• Study First Posted: 2017-03-08
• Last Update Posted: 2017-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Parkinson's Disease

Exclusion Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Bela-p-K	15 minuts	questionnaire for QoL evaluation