Validation of a Hypoparathyroidism Self-questionnaire (NCT05642741) | Clinical Trial Compass
CompletedNot Applicable
Validation of a Hypoparathyroidism Self-questionnaire
France81 participantsStarted 2023-05-02
Plain-language summary
The aim of this study is to evaluate, for patients with post-thyroidectomy hypoparathyroidism (HoPT), the severity of their HoPT and to validate clinical scores from a self-administered questionnaire related to this disease (questionnaire which evaluates the severity of clinical symptoms related to HoPT and their impact on quality of life) in order to assess the severity of HoPT and to optimize support.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Major patient
* Patients undergoing total thyroidectomy
* Patients with permanent hypoparathyroidism defined by a parathyroid hormone concentration ≤ 25 pg/mL more than 6 months after surgery and who require vitamin and calcium therapy.
* Not being opposed to participating in the study (questionnaires will be sent with the study information note. If the patient returns the questionnaires: we will consider that he/she is not opposed to participate in this study)
* Participants must be affiliated to a social security system
Exclusion Criteria:
* Pregnant women when filling out questionnaires (the child's parathyroids can correct the mother's hypoparathyroidism)
* Minors or protected patients (under guardianship)
* Patients under court protection
* Patients on long-term vitamin-calcium therapy after total thyroidectomy whose PTH concentration has not been controlled or whose concentration is higher than 25 pg/mL.
* Hypoparathyroid patients of other origin than post-thyroidectomy
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Validate two clinical scores (a symptom importance score and a symptom impact score in daily life) from a questionnaire adapted to hypoparathyroidism, in order to better assess the severity of HoPT and optimize management.