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Not yet recruiting NCT07636681

Effect of Medication Adherence-Based Digital Intervention on Fatigue Severity, Weight, and Thyroid Hormone Regulation

No phase Interventional Hypothyroidism

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: medication adherence based digital intervention.
Who it may be relevant to
Registry conditions: Hypothyroidism. Basic parameters: 18 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Iraq
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Effect of Medication Adherence-Based Digital Intervention on Fatigue Severity, Weight, and Thyroid Hormone Regulation in Patients With Hypothyroidism: A Randomized Controlled Trial

Overview

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

  • Other medication 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

Primary outcome measures

  • Change in Fatigue Severity Score [Time frame: Baseline and 3 months after intervention]
  • Change in Body Weight [Time frame: Baseline and 3 months after intervention.]
  • Change in Thyroid Hormone Levels [Time frame: Baseline and 3 months after intervention.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Supportive care

Study locations

Iraq · 1 center
  • University of Baghdad — Baghdad

Identifiers

NCT: NCT07636681 · MA-Based Digital Intervention

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗