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

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ClinicalTrials.gov Identifier: NCT03073044
Recruitment Status : Completed
First Posted : March 8, 2017
Last Update Posted : March 8, 2017
Sponsor:
Information provided by (Responsible Party):
Ilaria Zivi, 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

Condition or disease Intervention/treatment
Parkinson Disease Diagnostic Test: BELASTUNGSFRAGEBOGEN PARKINSON KURZVERSION (BELA-P-K)

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


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Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Retrospective
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.
Actual Study Start Date : September 1, 2015
Actual Primary Completion Date : September 1, 2016
Actual Study Completion Date : February 1, 2017

Resource links provided by the National Library of Medicine



Intervention Details:
  • 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



Primary Outcome Measures :
  1. Bela-p-K [ Time Frame: 15 minuts ]
    questionnaire for QoL evaluation



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients with idiopathic Parkinson Disease
Criteria

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

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ilaria Zivi, Dipartimento di riabilitazione malattia di Parkinson, Disturbi del movimento e Cerebrolesioni Acquisite, Ospedale Generale Di Zona Moriggia-Pelascini
ClinicalTrials.gov Identifier: NCT03073044     History of Changes
Other Study ID Numbers: Bela-p-K
First Posted: March 8, 2017    Key Record Dates
Last Update Posted: March 8, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ilaria Zivi, Ospedale Generale Di Zona Moriggia-Pelascini:
Quality of life
psychosocial and psychological problems

Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases