THYROIDAL

Quality of Life in Autoimmune Hypothyroidism - THYROIDAL

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON61518

Enrollment

600

Registered

2026-04-09

Start date

2026-09-11

Completion date

Unknown

Last updated

2026-08-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autoimmune hypothyroidism Underactive thyroid gland

Interventions

This is a non-interventional study

no investigational or non-investigational products (e.g., drugs, devices) will be administered. All procedures, including blood sampling, questionnaires, and neurocognitive tests, are standard diagnos

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Diagnosis autoimmune hypothyroidismMinimal daily dose levothyroxine of 75 micrograms

Exclusion criteria

Exclusion criteria: Non-autoimmune hypothyroidismUse of liothyronine (LT3) therapy

Design outcomes

Primary

Measure	Time frame
The primary outcome is the ThyPRO Tiredness score, a validated 7-item subscale of the ThyPRO questionnaire specifically designed to assess fatigue in patients with benign thyroid diseases. The score is calculated as the mean of completed items (with missing items imputed if =50% of the subscale is completed). This outcome was selected due to the high prevalence and debilitating nature of fatigue in LT4-treated hypothyroidism.	—

Measure

Time frame

The primary outcome is the ThyPRO Tiredness score, a validated 7-item subscale of the ThyPRO questionnaire specifically designed to assess fatigue in patients with benign thyroid diseases. The score is calculated as the mean of completed items (with missing items imputed if =50% of the subscale is completed). This outcome was selected due to the high prevalence and debilitating nature of fatigue in LT4-treated hypothyroidism.

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Secondary

Measure	Time frame
Thyroid-related QoL:ThyPRO-39 composite score (22 items across 8 subscales: Tiredness, Cognition, Anxiety, Depressivity, Emotional Susceptibility, Impaired Social Life, Impaired Daily Life, Overall QoL).Non-tiredness ThyPRO-39 subscales (e.g., Cognition, Anxiety, Depressivity).Generic QoL:EQ-5D-5L (5 dimensions: mobility, self-care, usual activities, pain/discomfort, anxiety/depression) and EQ-5D Visual Analogue Scale (VAS).Neurocognitive Performance:Norm-referenced scores for:Digit Span, Logical Memory I/II, RAVLT (learning/memory).Digit Symbol, TAP Alertness (psychomotor speed).PASAT, Brixton Test (executive function).Correspondence analysis: Pearson correlation between objective neurocognitive scores and subjective cognitive complaints (ThyPRO-39 Cognition subscale).Healthcare Utilization and Productivity Costs:iMCQ: Medical consumption (e.g., hospital visits, medication use).iPCQ: Productivity loss (e.g., absenteeism, presenteeism).Costs will be calculated using Dutch standard unit prices and reported as medians (with interquartile ranges) due to expected skewness.	—

Measure

Time frame

Thyroid-related QoL:ThyPRO-39 composite score (22 items across 8 subscales: Tiredness, Cognition, Anxiety, Depressivity, Emotional Susceptibility, Impaired Social Life, Impaired Daily Life, Overall QoL).Non-tiredness ThyPRO-39 subscales (e.g., Cognition, Anxiety, Depressivity).Generic QoL:EQ-5D-5L (5 dimensions: mobility, self-care, usual activities, pain/discomfort, anxiety/depression) and EQ-5D Visual Analogue Scale (VAS).Neurocognitive Performance:Norm-referenced scores for:Digit Span, Logical Memory I/II, RAVLT (learning/memory).Digit Symbol, TAP Alertness (psychomotor speed).PASAT, Brixton Test (executive function).Correspondence analysis: Pearson correlation between objective neurocognitive scores and subjective cognitive complaints (ThyPRO-39 Cognition subscale).Healthcare Utilization and Productivity Costs:iMCQ: Medical consumption (e.g., hospital visits, medication use).iPCQ: Productivity loss (e.g., absenteeism, presenteeism).Costs will be calculated using Dutch standard unit prices and reported as medians (with interquartile ranges) due to expected skewness.

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Countries

Netherlands

Contacts

Public ContactM. Medici

Erasmus MC, Universitair Medisch Centrum Rotterdam

levenmethypo@erasmusmc.nl0629633627

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Sep 19, 2026