About this trial
This is a crossectional study that will be conducted at several tertiary centers in Greece.
To participate in the study, patients should be ≥18 years of age, fluent in Greek language, diagnosed with chronic HP, on optimal treatment with calcium and active vitamin D metabolites. Chronic HP is defined when continuous therapy with calcium and vitamin D is required for \>12 months.
Exclusion criteria will include:
1. Patients inadequately controlled with conventional therapy:
1. corrected serum Ca (cCa) ≤8 mg/dl or cCa ≤8.2 mg/dl with symptoms of hypocalcemia 2. serum P \>5.5 mg/dl 2. Age \>80 years 3. Presence of neoplastic disease 4. Pregnancy 5. Diagnosis of psychiatric disease or cognitive impairment 6. Participants experiencing other comorbidities that may affect QoL 7. Lack of informed consent The study will seek approval from the Ethics in Research Committee of its participating center. All participants will be informed about the objectives of the study and will sign an informed consent.
The HPES-Symptom was developed in accordance with the Food and Drug Administration guidance and best research practices for PRO measure development. The methodology used has been previously described.
The first step of the translation process requires two forward translations of the English version of the questionnaire. The translations will be done by two translators who are native speakers of the target (Greek) language and can understand the English version. Then a reconciled translation is made based on the two translations - that is, the chief investigator will review the two translations to achieve the best possible version by choosing one of the two translations or by combining them on the basis of their correctness, wording etc.
The next step requires translating the reconciled version back into English, again done by two translators who will be native speakers of English or at least will have a very good command of English.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
corrected serum Ca (cCa) ≤8 mg/dl or cCa ≤8.2 mg/dl with symptoms of hypocalcemia
serum P >5.5 mg/dl
Age >80 years
Presence of neoplastic disease
Trial population
Patients with chronic hypoparathyroidism ≥18 years of age
Trial design
Case-only
Cross-sectional
Treatments tested in this trial
Questionnaire and Physical Exam
Other interventionTranslation and validation of the existing HPES-Symptom and HPES-Impact Questionnaires in the Greek population
Treatment groups
Trial outcomes
Primary outcomes
Translation and validation the HPES-Symptom and the HPES-Impact questionnaires in Greek
To translate and validate the HPES-Symptom and the HPES-Impact questionnaires for patients with chronic hypoparathyroidism for use in the Greek population
Translation and validation the HPES-Symptom and the HPES-Impact questionnaires in Greek
To translate and validate the HPES-Symptom and the HPES-Impact questionnaires for patients with chronic hypoparathyroidism for use in the Greek population
Locations
Sponsors and contacts
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Aristotle University Of Thessaloniki
Lead sponsor
National and Kapodistrian University of Athens
Collaborator
424 General Military Hospital
Collaborator
General Hospital Of Thessaloniki Ippokratio
Collaborator
Laikο General Hospital, Athens
Collaborator
251 Hellenic Air Force & VA General Hospital
Collaborator
Hellenic Red Cross Hospital
Collaborator
This trial is not recruiting at the moment. You can still explore other options: