Parkinson DiseaseNCT03073044
Translation and Validation of BELA-p-K for QoL Evaluation in PD Patients
An observational study of Parkinson Disease, run by Ospedale Generale Di Zona Moriggia-Pelascini.
Trial summary
The BELA-P-k was translated from Dutch into Italian. Subsequently 102 patients with PD filled out the questionnaire Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- BELASTUNGSFRAGEBOGEN PARKINSON KURZVERSION (BELA-P-K)
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2015to 1 Feb 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients with idiopathic Parkinson Disease
Who may be able to join
- Parkinson's Disease
Who cannot join
- 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
About this study
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.
The BELA-P-k was translated from Dutch into Italian. Subsequently 102 patients with PD filled out the questionnaire
Read the 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
- Parkinson Disease
- Being tested
- BELASTUNGSFRAGEBOGEN PARKINSON KURZVERSION (BELA-P-K)
- Keywords
- Quality of life, psychosocial and psychological problems
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BELASTUNGSFRAGEBOGEN PARKINSON KURZVERSION (BELA-P-K)Diagnostic test
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
What is being measured
The primary outcome is the main question the study is designed to answer.
Bela-p-K
questionnaire for QoL evaluation
Measured: 15 minuts
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2017
- Study start1 Sep 2015
- Primary completion1 Sep 2016
- Study completion1 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ospedale Generale Di Zona Moriggia-Pelascini
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ilaria Zivi, Ospedale Generale Di Zona Moriggia-Pelascini
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03073044
- Sponsor's protocol ID
- Bela-p-K
- Status last verified
- Mar 2017
- First submitted
- 22 Feb 2017
- Last updated
- 8 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 12722163Ringendahl 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.
PubMed 11139990Ortelli 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.
PubMed 28770096
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03073044
- Acronym / sponsor ID
- Bela-p-K
- Conditions
- Parkinson Disease
- Keywords
- Quality of life, psychosocial and psychological problems
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Ospedale Generale Di Zona Moriggia-PelasciniUniversity, hospital or other
- Study start
- 1 Sep 2015 (actual)
- Primary completion
- 1 Sep 2016 (actual)
- Study completion
- 1 Feb 2017 (actual)
- First posted
- 8 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with idiopathic Parkinson Disease
Key inclusion criteria (1 listed)
- Parkinson's Disease
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Diagnostic test | – |
Primary outcome
Bela-p-K
Time frame: 15 minuts
questionnaire for QoL evaluation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2017.
- Background: PubMed 12722163Spliethoff-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.
- Background: PubMed 11139990Ringendahl 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.
- Derived from this study: PubMed 28770096Ortelli 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease, run by Ospedale Generale Di Zona Moriggia-Pelascini.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bela-p-K (time frame: 15 minuts). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03073044, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2017.