Study of Optimal Replacement of Thyroxine in the Elderly (SORTED)
All patients with hypothyroidism are currently treated the same way, regardless of age. The investigators want to look at whether people aged 80 years or older would benefit from being treated with lower doses of levothyroxine. There are three reasons why the investigators think this could be beneficial, but this is not yet proven:
- Some older people with hypothyroidism may have few symptoms.
- Doctors look at the amount of Thyroid Stimulating Hormone (TSH) in the patient's blood to decide the dose of Thyroxine received. The standard "normal" TSH range used to determine the dose of levothyroxine is from younger people. The investigators wonder whether this is appropriate to all age ranges particularly as the investigators know that older people may normally have higher TSH values.
- If TSH levels are too low there may be a slight increased risk of problems such as brittle bones or an irregular heartbeat.
The best way to test whether older people benefit from lower doses of levothyroxine is by a large clinical trial. Before the investigators can do this, the investigators need to run a smaller clinical trial called a "pilot study" (SORTED 1) to examine whether this is practical and acceptable. The pilot study aims to recruit 50 patients with hypothyroidism aged 80 or above.
Participants will be randomly allocated to receive their routine or lower dose of levothyroxine. Follow-up will be conducted over approximately 25 weeks.
The investigators also propose a qualitative study (SORTED 2) to specifically understand patient's willingness to take part in a RCT and participant's experience of the intervention.
Finally, the investigators propose a retrospective cohort study of 400 treated hypothyroid patients aged 80 years or more registered in 2008 in Primary Care Practices with the aim of studying outcomes after 4 years. The cohort study will collect data required to inform a sample size calculation for a future full study where the primary outcome will be 4 year mortality.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
|Official Title:||Study of Optimal Replacement of Thyroxine in the Elderly (SORTED) SORTED 1 - a Randomised Controlled Trial (Pilot Study), SORTED 2 - Qualitative Interviews, SORTED 3 - Retrospective Cohort|
- Participant's acceptability of study design and willingness to enter study [ Time Frame: Until completion of recruitment, approximately 24 months ] [ Designated as safety issue: No ]Participant's acceptability of study design as measured byt he completion rate of participants in each randomised group, as well as their willingness to enter the trial (consented participant to eligible participant approached ratio)
- Participant recruitment rate [ Time Frame: Until completion of recruitment, approximately 24 months ] [ Designated as safety issue: No ]As measured by the number of patients randomised divided by the length of the recruitment period. The recruitment period runs from the date that recruitment opened to the date of last randomisation.
- Time to achieve desired TSH levels [ Time Frame: Until participant completion of SORTED 1 study, approximately within 24 weeks ] [ Designated as safety issue: No ]To review and assess the dose titration strategy (ie reduced LT4 dose or same dose LT4) and length of time required to achieved desired TSH levels (ie number of participants in each group that reach target TSH range at both 12 and 24 weeks)
- Medication compliance [ Time Frame: For the duration of participant involvment in the study, maximum of 25 weeks ] [ Designated as safety issue: No ]Tablet count
- The acceptability of three patient completed questionnaires [ Time Frame: For the duration of participant involvement in the study, maximum of 25 weeks ] [ Designated as safety issue: No ]The questionnaires include the generic QoL questionnaire (EQ-5D), validated disease-specific QoL questionanaire (ThyDQol) and disease specific hypothyroid-symptom check list (ThySC). The time taken to complete the three questionnaires will be recorded and questionnaire completion rates will be recorded and usefulnesss of questionnaires determined. Any third-party held required in a questionnaire's completion will be recorded.
- Assessment of mobility [ Time Frame: For the duration of participant involvement in this study, maximum of 25 weeks ] [ Designated as safety issue: No ]Measured by the nurse administered TUG Test, and the FRAT (Falls Risk Assessment Tool)
- Change in specific cardiovascular risk factors [ Time Frame: For the duration of participant involvement in the study, maximum of 25 weeks ] [ Designated as safety issue: Yes ]Lipid profile (total cholesterol, HDL, Triglycerides), blood pressure and body weight, and serum results
- Measure of risk of falls [ Time Frame: For the duration of participant involvement in the study, maximum 25 weeks ] [ Designated as safety issue: No ]Measure by nurse administrated FRAT (Falls Risk Assessment Tool) test.
|Study Start Date:||August 2012|
|Estimated Study Completion Date:||August 2014|
|Estimated Primary Completion Date:||August 2014 (Final data collection date for primary outcome measure)|
Lower dose of levothyroxine
Participants may be randomised to receive a lower dose of levothyroxine (lower than their usual dose) to achieve a target TSH level of 4.1 - 8.0 mU/L
Participants in the lower dose arm of the study will receive a lower dose of levothyroxine than their usual dose
Standard dose of levothyroxine
Patients may be randomised to receive their usual dose of levothyroxine (target TSH level 0.4 - 4.0 mU/L)
Participants in the standard dose of treatment will receive their usual dose of levothyroxine
Please refer to this study by its ClinicalTrials.gov identifier: NCT01647750
|Contact: Salman Razvi||0191 445 firstname.lastname@example.org|
|Contact: Melinda Jeffels||0191 222 email@example.com|
|Gateshead, Tyne and Wear, United Kingdom, NE8 4YL|
|Contact: Lorna Ingoe firstname.lastname@example.org|
|Principal Investigator: Salman Razvi|
|Clinical Research Facility||Recruiting|
|Newcastle upon Tyne, Tyne and Wear, United Kingdom, NE1 4LP|
|Contact: Valerie Corrall 01912464672 CRF.DRNemail@example.com|
|Contact: Sarah Groves 0191 282 0084 CRF.DRNfirstname.lastname@example.org|
|Principal Investigator: Simon Pearce|
|Principal Investigator:||Salman Razvi||Gateshead Health NHS Foundation Trust|