hypothyroidism (elderly individuals)
Conditions
Interventions
Trade Name: Eltroxin 25 micrograms tablets and Eltroxin 50 micrograms tablets
Product Name: levothyroxine sodium
Pharmaceutical Form: Capsule
INN or Proposed INN: levothyroxine sodium
Concentration un
Sponsors
Newcastle Upon Tyne Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: SORTED 1 Inclusion criteria: • Males and females aged 80 years or older • Diagnosed with hypothyroidism and treated with LT4 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. SORTED 2 Inclusion criteria: • Individuals who have provided written informed consent to participate in the SORTED 1 Study (Group 1) or individuals who have been approached and who have formally declined to participate in the SORTED 1 Study (Group 2). Eligibility for SORTED 2 will already be verified via approach of the patient in relation to SORTED 1. SORTED 3: A total of 400 individuals who were 80 years or more in 2008 and were being treated for hypothyroidism. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range 0 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
Exclusion criteria: SORTED 1 Exclusion criteria: • Established dementia and therefore deemed incapable of providing informed consent. • Other medical conditions which, in the 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 daily 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): SORTED 1: • Participants willingness to enter the trial (consented participant to eligible participants approached ratio). • Participants acceptability of study design (as measured by the completion rate of participants in each randomised group). • Participant recruitment rate (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 the last randomisation. • The dose titration strategy, described above, and length of time required to achieve desired TSH levels (number of participants in each group that reach target TSH range at both 12 and 24 weeks). • Medication compliance (tablet count). SORTED 2 (Objectives): • To explore the reasons for participation in a randomised control trial (SORTED 1 Study) amongst community dwelling people aged 80 years and over with levothyroxine treated primary hypothyroidism • To explore the reasons for non-participation in a randomised control trial (SORTED 1 Study) amongst community dwelling people aged 80 years and over with levothyroxine treated primary hypothyroidism • To examine the decision-making process that elderly people make in choosing whether to participate in a randomised control trial (SORTED 1 Study) • To explore aspects of health and well-being with differing doses of levothyroxine replacement for primary hypothyroid disease amongst community dwelling people aged 80 years and over. • To explore issues around retaining elderly people in a clinical trial (SORTED 1 Study) for its duration. SORTED 3: Assessment of mortality rate for L-thyroxine treated hypothyroid individuals aged 80 years or more over the subsequent 4 years.;Main Objective: SORTED 1: • To assess participant’s willingness to enter the trial • To gauge participant’s acceptability of study design. • To study length of time required to complete recruitment. • To assess the dose titration strategy, described | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • The acceptability and usefulness of three patient completed questionnaires, a generic QOL questionnaire (EQ5D),a validated disease specific QoL questionnaire (ThyDQoL), and the disease specific hypothyroid symptom check list (ThySC). The time taken to complete the three questionnaires will be recorded and questionnaire completion rates will be calculated. Any third party help required in a questionnaire's completion will be recorded. • Assessment of mobility and risk of falls in this population group as measured by the nurse administered Timed Up and Go Test, and the Falls Risk Assessment Test – page 1 only for the FRAT). • Change in specific cardiovascular risk factors (lipid profile (Total cholesterol, High Density Lipoprotein,Triglycerides), blood pressure and body weight) and bone resorption marker (serum collagen type 1 cross-linked C-telopeptide).;Timepoint(s) of evaluation of this end point: • The acceptability and usefulness of three patient completed questionnaires, a generic QOL questionnaire (EQ5D), a validated disease specific QoL questionnaire (ThyDQoL), and the disease specific hypothyroid symptom check list (ThySC) – Baseline & Visit 3 • Assessment of mobility and risk of falls in this population group as measured by the nurse administered Timed Up and Go Test, and the Falls Risk Assessment Test (page 1 only for the FRAT) – Baseline & Visit 3 • Change in specific cardiovascular risk factors (lipid profile (Total cholesterol, High Density Lipoprotein,Triglycerides), blood pressure and body weight) and bone resorption marker (serum collagen type 1 cross-linked C-telopeptide) – Baseline & Visit 3 | — |
Countries
United Kingdom
Contacts
Public ContactDr Salman Razvi
Gateshead Health NHS Foundation Trust
Outcome results
None listed