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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorUniversity of Baghdad

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • medication adherence based digital intervention

    Other 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

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Control GroupNo intervention 0 interventions
Group B: Intervention GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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).

Time frame
Baseline and 3 months after intervention
2

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).

Time frame
Baseline and 3 months after intervention.
3

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.

Time frame
Baseline and 3 months after intervention.

Secondary outcomes

Other outcomes

Sponsors and contacts

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