NCT Number: NCT06455371
Levothyroxine is the most used thyroid hormone replacement when the thyroid gland is failing. Because dosage adjustment normally takes several months, the investigators have developed a decision support tool (DST) that predicts optimal dosage based on repeated blood samples the first 2 weeks after initiation of therapy. In this randomized study the investigators will include patients that start levothyroxine therapy after total thyroidectomy. The use of DST to advice the physician about an early dosage adjustment will be compared with common clinical practice, that is dosage adjustment every 2 months. The effect of DST use will be assessed by studying the possible relationship between fast optimal dose adjustment, patient reported outcome measures, and ability to work.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Haukeland University Hospital, Bergen, Norway
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients in the intervention groups are given the option to use the decision support tool when adjusting the levothyroxine dose after total thyroidectomy. Levothyroxine therapy is not a part of the intervention, as all patients receive this therapy regardless of study participation.
Time frame: Outcome is measured at 8 weeks, 6 months and 12 months post surgery
Number of patients at biochemical target. Biochemical target is TSH (thyroid stimulating hormone) 0,5-2,0 mIE/L for patients on substitution therapy and 0,1-0,5 mIE/L for patients on suppression therapy
Time frame: Measured at 18 months after surgery
Time to biochemical target is reached measured in days. Day 0 is day of surgery
Time frame: Measured at 8 weeks post surgery
Distance measured in TSH units.
Time frame: Measured at 2 weeks before surgery, 2 months after surgery and 6 months after surgery surgery
Patient reported outcomes measured by the validated questionnaire ThyPRO39. The ThyPRO39 questionnaire consist of 12 scales that covers physical symptoms (goiter, eye symptoms, hypo- and hyperthyroid symptoms), cosmetic appearance, physical, mental and social well-being and function. Each item is rated on a 0-4 scale from 0 = no symptoms/problems to 4 = Severe symptoms/problems. The average score of items in a scale is divided by four and multiplied by 100 to yield thirteen 0-100 scales, with higher scores indicating worse health status.
The questionnaire will be distributed three times during the study. The first measurement will be two weeks before surgery and represent the baseline. The questionnaire is distributed again at 2 months and 6 months after surgery and changes from baseline will be measured and compared between groups.
Time frame: Measured at 2 weeks before surgery, 2 months after surgery and 6 months after surgery surgery
Rand-36 is the Norwegian translation of the SF-36 version 1.2. The questionnaire consists of 36 items, grouped into eight multi-item scales that measure physical functioning, role limitations due to physical problems, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems and mental health. The scores can also be summarized into two summary scores for overall physical and mental health. Items scores will be transformed to 0-100 point scales (0=worst, 100=best) using the SF-36 scoring algorithm
The questionnaire will be distributed three times during the study. The first measurement will be two weeks before surgery and represent the baseline. The questionnaire is distributed again at 2 months and 6 months after surgery and changes from baseline will be measured and compared between groups.
Time frame: Measured at18 months after surgery
Days with sick-leave from work the first year after surgery. Data collected from the Norwegian national sick-leave registry
Contact information is provided by the study sponsor or research team.
Solveig Brun, cand.med
CONTACT
Vegard Brun, PhD
CONTACT
University Hospital of North Norway
Other
Patient-centered Decision Support Tool for Levothyroxine Dosage
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT04782856
Endocrine Gland Neoplasms, Endocrine System Diseases
Richmond, Virginia, United States
View Trial DetailsNCT04860622
Dysfunction, Endocrine System Diseases
Istanbul, Turkey (Türkiye)
View Trial DetailsNCT06345339
Endocrine System Diseases, Hypothyroidism
Birmingham, Alabama, United States
View Trial DetailsNCT03977207
Endocrine System Diseases, Hemodialysis
Orange, California, United States
View Trial Details