An interventional study of Decision support tool in Hypothyroidism, Thyroid Cancer and Thyroid, sponsored by University Hospital of North Norway. Recruiting at 3 sites in Norway. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-10.
Sponsored by University Hospital of North Norway · Not applicable, Interventional, and Treatment
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.
217 studies on the registry are indexed under Hypothyroidism; 50 are open to participants now.
This study's planned enrollment of 240 is above the median of 70 across 109 interventional studies indexed under Hypothyroidism.
Browse Hypothyroidism studies →University Hospital of North Norway is the lead sponsor of 152 studies on the registry; 24 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Current clinical practise. Levothyroxine dose is calculated based on weight and adjusted according to TSH-level at 6-8 week intervals until biochemical target is reached
Levothyroxine dose is calculated using the current version of the decision support tool based on 4 blood samples.
Other: Decision support tool
Levothyroxine dose is calculated using an improved mathematical model in the decision support tool based on 4 blood samples.
Other: Decision support tool
Levothyroxine dose is calculated using an improved mathematical model in the decision support tool based on 2 blood samples.
Other: Decision support tool
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.
Number of patients at biochemical target
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: Outcome is measured at 8 weeks, 6 months and 12 months post surgery
Time to biochemical target
Time to biochemical target is reached measured in days. Day 0 is day of surgery
Time frame: Measured at 18 months after surgery
Distance from biochemical target
Distance measured in TSH units.
Time frame: Measured at 8 weeks post surgery
Patient reported outcome - ThyPRO39 questionnaire
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
Patient reported outcome - RAND-36 questionnaire
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 at 2 weeks before surgery, 2 months after surgery and 6 months after surgery surgery
Abscence from work
Days with sick-leave from work the first year after surgery. Data collected from the Norwegian national sick-leave registry
Time frame: Measured at18 months after surgery
Plan to share: No
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