Study of Optimal Replacement of Thyroxine in the Elderly (SORTED)
7 ottobre 2015 aggiornato da: Newcastle-upon-Tyne Hospitals NHS Trust
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
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.
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Tipo di studio
Interventistico
Iscrizione (Effettivo)
48
Fase
- Fase 4
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Tyne and Wear
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Gateshead, Tyne and Wear, Regno Unito, NE8 4YL
- Bensham Hospital
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Newcastle upon Tyne, Tyne and Wear, Regno Unito, NE1 4LP
- Clinical Research Facility
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
80 anni e precedenti (Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
Inclusion Criteria:
- Males and Females aged 80 years or older
- Diagnosed with hypothyroidism and treated with Levothyroxine for at least 6 months
- Living independently in the community
- All TSH results within the range 0.4 - 4mU/L in the 3 months before commencing the study
- Participant has provided written informed consent for participation in the study, prior to any study-specific procedures
Exclusion Criteria:
- Established dementia and therefore deemed incapable of providing informed consent.
- Other medical conditions which, inthe opinion of the Chief Investigator, would prevent them from participating in the study (for example, end stage cancer, severe chronic health conditions where the patient is housebound)
- Nursing Homes or Residential Care Home residents
- Individuals with thyroid cancer: since they require high doses of LT4 to suppress their serum TSH
- Individuals on 25 mcg dailty of LT4: dose reduction will mean that they stop thyroid replacement treatment
- Non english speaking individuals
- Participation in any other investigational trials within the last 3 months
- Participants prescribed medications that can affect thyroid function (amiodarone, lithium, carbimazole or propylthiouracil)
- Known or suspected lactose intolerance (this would have implications for the proposed over-encapsulated IMP)
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Altro: 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
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Participants in the lower dose arm of the study will receive a lower dose of levothyroxine than their usual dose
Participants in the standard dose of treatment will receive their usual dose of levothyroxine
|
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Altro: Standard dose of levothyroxine
Patients may be randomised to receive their usual dose of levothyroxine (target TSH level 0.4 - 4.0 mU/L)
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Participants in the lower dose arm of the study will receive a lower dose of levothyroxine than their usual dose
Participants in the standard dose of treatment will receive their usual dose of levothyroxine
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Participant's acceptability of study design and willingness to enter study
Lasso di tempo: Until completion of recruitment, approximately 24 months
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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)
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Until completion of recruitment, approximately 24 months
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Participant recruitment rate
Lasso di tempo: Until completion of recruitment, approximately 24 months
|
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.
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Until completion of recruitment, approximately 24 months
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Time to achieve desired TSH levels
Lasso di tempo: Until participant completion of SORTED 1 study, approximately within 24 weeks
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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)
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Until participant completion of SORTED 1 study, approximately within 24 weeks
|
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Medication compliance
Lasso di tempo: For the duration of participant involvment in the study, maximum of 25 weeks
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Tablet count
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For the duration of participant involvment in the study, maximum of 25 weeks
|
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The acceptability of three patient completed questionnaires
Lasso di tempo: For the duration of participant involvement in the study, maximum of 25 weeks
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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.
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For the duration of participant involvement in the study, maximum of 25 weeks
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Assessment of mobility
Lasso di tempo: For the duration of participant involvement in this study, maximum of 25 weeks
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Measured by the nurse administered TUG Test, and the FRAT (Falls Risk Assessment Tool)
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For the duration of participant involvement in this study, maximum of 25 weeks
|
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Change in specific cardiovascular risk factors
Lasso di tempo: For the duration of participant involvement in the study, maximum of 25 weeks
|
Lipid profile (total cholesterol, HDL, Triglycerides), blood pressure and body weight, and serum results
|
For the duration of participant involvement in the study, maximum of 25 weeks
|
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Measure of risk of falls
Lasso di tempo: For the duration of participant involvement in the study, maximum 25 weeks
|
Measure by nurse administrated FRAT (Falls Risk Assessment Tool) test.
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For the duration of participant involvement in the study, maximum 25 weeks
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Collaboratori
Investigatori
- Investigatore principale: Salman Razvi, Gateshead Health NHS Foundation Trust
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 agosto 2012
Completamento primario (Effettivo)
1 agosto 2014
Completamento dello studio (Effettivo)
1 agosto 2014
Date di iscrizione allo studio
Primo inviato
16 luglio 2012
Primo inviato che soddisfa i criteri di controllo qualità
19 luglio 2012
Primo Inserito (Stima)
24 luglio 2012
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
12 ottobre 2015
Ultimo aggiornamento inviato che soddisfa i criteri QC
7 ottobre 2015
Ultimo verificato
1 ottobre 2015
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 5863 (Altro identificatore: Project ID - Ethical Committee UZA)
- PB-PG-0610-22139 (Altro numero di sovvenzione/finanziamento: National Institute for Health Research Research for patient Benefit)
- 2011-004425-27 (Numero EudraCT)
- ISRCTN16043724 (Identificatore di registro: ISRCTN)
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .