Study of Optimal Replacement of Thyroxine in the Elderly (SORTED)
2015年10月7日 更新者：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.
調査の概要
研究の種類
介入
入学 (実際)
48
段階
- フェーズ 4
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Tyne and Wear
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Gateshead、Tyne and Wear、イギリス、NE8 4YL
- Bensham Hospital
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Newcastle upon Tyne、Tyne and Wear、イギリス、NE1 4LP
- Clinical Research Facility
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-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
80年歳以上 (高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
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)
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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他の：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
Participants in the standard dose of treatment will receive their usual dose of levothyroxine
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他の：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
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Participant's acceptability of study design and willingness to enter study
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Participant recruitment rate
時間枠：Until completion of recruitment, approximately 24 months
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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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：For the duration of participant involvement in the study, maximum of 25 weeks
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Lipid profile (total cholesterol, HDL, Triglycerides), blood pressure and body weight, and serum results
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For the duration of participant involvement in the study, maximum of 25 weeks
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Measure of risk of falls
時間枠：For the duration of participant involvement in the study, maximum 25 weeks
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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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Salman Razvi、Gateshead Health NHS Foundation Trust
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2012年8月1日
一次修了 (実際)
2014年8月1日
研究の完了 (実際)
2014年8月1日
試験登録日
最初に提出
2012年7月16日
QC基準を満たした最初の提出物
2012年7月19日
最初の投稿 (見積もり)
2012年7月24日
学習記録の更新
投稿された最後の更新 (見積もり)
2015年10月12日
QC基準を満たした最後の更新が送信されました
2015年10月7日
最終確認日
2015年10月1日
詳しくは
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