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

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03073044
• Other study ID #: Bela-p-K
• Status: Completed
• Phase: N/A
• First received: February 22, 2017
• Last updated: March 2, 2017
• Start date: September 1, 2015
• Est. completion date: February 1, 2017

Study information

• Verified date: March 2017
• Source: Ospedale Generale Di Zona Moriggia-Pelascini
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: February 1, 2017
• Est. primary completion date: September 1, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Diagnostic Test:
• BELASTUNGSFRAGEBOGEN 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ospedale Generale Di Zona Moriggia-Pelascini

References & Publications (2)

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. Review. German. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bela-p-K	questionnaire for QoL evaluation	15 minuts