Hypothyroidism
Conditions
Brief summary
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.
Interventions
OTHERmedication adherence based digital intervention
participants 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
Sponsors
University of Baghdad
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* 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 * poor medication adherence, clinically significant fatigue, documented weight fluctuations and abnormal thyroid hormone
Exclusion criteria
* Secondary hypothyroidism or recent thyroidectomy/radioactive iodine therapy. * Pregnancy or breastfeeding woman. * Severe psychiatric disorders or cognitive impairment * significant visual or hearing deficits * Serious comorbidities affecting medication adherence (e.g., chronic disease, renal, or hepatic disease). * take dietary supplements or medications that interfere with levothyroxine absorption.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Fatigue Severity Score | Baseline and 3 months after intervention | 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 | Baseline and 3 months after intervention. | 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 | Baseline and 3 months after intervention. | 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. |
Countries
Iraq
Contacts
CONTACTShahad Sabah Khudhair
Outcome results
None listed