Patient-centered Decision Support Tool for Levothyroxine Dosage

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Total or completion thyroidectomy for differentiated thyroid cancer og benign thyroid nodules at Norwegian hospitals

Locations
Other Locations
Norway
Haukeland University Hospital
RECRUITING
Bergen
Oslo University Hospital
RECRUITING
Oslo
University Hospital of North Norway
RECRUITING
Tromsø
Contact Information
Primary
Vegard Brun, PhD
vegard.heimly.brun@unn.no
0047 77669260
Backup
Solveig Brun, cand.med
solveig.konst@unn.no
004745253006
Time Frame
Start Date: 2024-12-20
Estimated Completion Date: 2027-12
Participants
Target number of participants: 240
Treatments
No_intervention: Control
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
Experimental: DST 1
Levothyroxine dose is calculated using the current version of the decision support tool based on 4 blood samples.
Experimental: DST 2
Levothyroxine dose is calculated using an improved mathematical model in the decision support tool based on 4 blood samples.
Experimental: DST 3
Levothyroxine dose is calculated using an improved mathematical model in the decision support tool based on 2 blood samples.
Sponsors
Collaborators: Norinnova, SINTEF Health Research, Helseapps, Helse Nord
Leads: University Hospital of North Norway

This content was sourced from clinicaltrials.gov