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Study of Optimal Replacement of Thyroxine in the Elderly (SORTED)

7. oktober 2015 opdateret af: 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:

  1. Some older people with hypothyroidism may have few symptoms.
  2. 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.
  3. 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

48

Fase

  • Fase 4

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Det Forenede Kongerige
    • Tyne and Wear
      • Gateshead, Tyne and Wear, Det Forenede Kongerige, NE8 4YL
        • Bensham Hospital
      • Newcastle upon Tyne, Tyne and Wear, Det Forenede Kongerige, NE1 4LP
        • Clinical Research Facility

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

80 år og ældre (Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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)

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Andet: 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
Medicin: Levothyroxine
Participants in the lower dose arm of the study will receive a lower dose of levothyroxine than their usual dose
Medicin: Levothyroxine
Participants in the standard dose of treatment will receive their usual dose of levothyroxine
Andet: Standard dose of levothyroxine
Patients may be randomised to receive their usual dose of levothyroxine (target TSH level 0.4 - 4.0 mU/L)
Medicin: Levothyroxine
Participants in the lower dose arm of the study will receive a lower dose of levothyroxine than their usual dose
Medicin: Levothyroxine
Participants in the standard dose of treatment will receive their usual dose of levothyroxine

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Participant's acceptability of study design and willingness to enter study
Tidsramme: Until completion of recruitment, approximately 24 months
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)
Until completion of recruitment, approximately 24 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Participant recruitment rate
Tidsramme: 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.
Until completion of recruitment, approximately 24 months
Time to achieve desired TSH levels
Tidsramme: Until participant completion of SORTED 1 study, approximately within 24 weeks
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)
Until participant completion of SORTED 1 study, approximately within 24 weeks
Medication compliance
Tidsramme: For the duration of participant involvment in the study, maximum of 25 weeks
Tablet count
For the duration of participant involvment in the study, maximum of 25 weeks
The acceptability of three patient completed questionnaires
Tidsramme: For the duration of participant involvement in the study, maximum of 25 weeks
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.
For the duration of participant involvement in the study, maximum of 25 weeks
Assessment of mobility
Tidsramme: For the duration of participant involvement in this study, maximum of 25 weeks
Measured by the nurse administered TUG Test, and the FRAT (Falls Risk Assessment Tool)
For the duration of participant involvement in this study, maximum of 25 weeks
Change in specific cardiovascular risk factors
Tidsramme: 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
Measure of risk of falls
Tidsramme: For the duration of participant involvement in the study, maximum 25 weeks
Measure by nurse administrated FRAT (Falls Risk Assessment Tool) test.
For the duration of participant involvement in the study, maximum 25 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Newcastle-upon-Tyne Hospitals NHS Trust

Samarbejdspartnere

National Institute for Health Research, United Kingdom

Efterforskere

  • Ledende efterforsker: Salman Razvi, Gateshead Health NHS Foundation Trust

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. august 2012

Primær færdiggørelse (Faktiske)

1. august 2014

Studieafslutning (Faktiske)

1. august 2014

Datoer for studieregistrering

Først indsendt

16. juli 2012

Først indsendt, der opfyldte QC-kriterier

19. juli 2012

Først opslået (Skøn)

24. juli 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

12. oktober 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

7. oktober 2015

Sidst verificeret

1. oktober 2015

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 5863 (Anden identifikator: Project ID - Ethical Committee UZA)
  • PB-PG-0610-22139 (Andet bevillings-/finansieringsnummer: National Institute for Health Research Research for patient Benefit)
  • 2011-004425-27 (EudraCT nummer)
  • ISRCTN16043724 (Registry Identifier: ISRCTN)

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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Placeringer

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