About this trial
1. To evaluate the effect of a medication adherence-based digital intervention on fatigue severity in patients with hypothyroidism. 2. To assess the effect of a medication adherence-based digital intervention on weight in patients with hypothyroidism. 3. To investigate the effect of a medication adherence-based digital intervention on thyroid hormone regulation in patients with hypothyroidism.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults (≥18 years) with primary hypothyroidism.
On stable levothyroxine therapy for at least 3 months.
Able to read, understand study instructions
capable of using basic mobile applications
Disqualifiers
Secondary hypothyroidism or recent thyroidectomy/radioactive iodine therapy.
Pregnancy or breastfeeding woman.
Severe psychiatric disorders or cognitive impairment
significant visual or hearing deficits
Trial design
Parallel
Treatments tested in this trial
medication adherence based digital intervention
Other interventionparticipants in the intervention group will receive digital support aimed at improving their adherence to prescribed medications. This support will include a smartphone application developed specifically for the study, as well as reminder messages via WhatsApp to prompt participants to take their levothyroxine at the scheduled times
Treatment groups
Trial outcomes
Primary outcomes
Change in Fatigue Severity Score
Assessment of the effectiveness of a medication adherence-based digital intervention on fatigue severity by using the Fatigue Severity Scale (FSS).
Change in Body Weight
Assessment of the effectiveness of a medication adherence-based digital intervention on weight by assessment of changes in Body Mass Index (BMI), calculated as weight in kilograms divided by height in meters squared (kg/m²).
Change in Thyroid Hormone Levels
Assessment of the effectiveness of a medication adherence-based digital intervention on Thyroid Hormone Levels by assessment of serum Thyroid Stimulating Hormone (TSH) and Free Thyroxine (FT4) levels.
Sponsors and contacts
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