Patient-centered Dosage of Levothyroxine
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital of North Norway
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Total or completion thyroidectomy for differentiated thyroid cancer og benign thyroid nodules at Norwegian hospitals
Disqualifiers
Anaplastic thyroid cancer, thyroid cancer with distant metastasis, graves disease, toxic nodules, pregnancy
Trial design
Design model
Parallel
Treatments tested in this trial
Decision support tool
Other interventionPatients 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.
Treatment groups
240 Participants
are divided into 4 treatment groupsGroup A: ControlNo intervention 0 interventions
Group B: DST 1Experimental treatment 1 intervention
Group C: DST 2Experimental treatment 1 intervention
Group D: DST 3Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 surgerySecondary outcomes
1
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 surgery2
Distance from biochemical target
Distance measured in TSH units.
Time frame
Measured at 8 weeks post surgery3
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 surgery4
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 surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
University Hospital of North Norway
Lead sponsor
SINTEF Health Research
Collaborator
Helseapps
Collaborator
Norinnova
Collaborator
Helse Nord
Collaborator
Source ClinicalTrials.gov