Improving medication adherence for hypothyroidism using a patient decision aid
An Interventional Study to Improve Medication Adherence Using Patient Decision Aid Among Adults With Under-Replaced HypoThyroidism (IMPART): A Randomized Control Study
This study is testing a new tool to help people with hypothyroidism understand their medication better and stick to their treatment plan.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 236 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | SingHealth Polyclinics Academic / other |
| Locations | 1 site (Singapore) |
| Trial ID | NCT06205303 on ClinicalTrials.gov |
What this trial studies
This study aims to enhance medication adherence among patients with hypothyroidism by utilizing a patient decision aid (PDA) that educates individuals about thyroxine replacement therapy. The intervention is based on the COM-B model, which focuses on improving patients' capability, motivation, and opportunity to adhere to their medication regimen. By providing valuable information and fostering communication between patients and healthcare providers, the PDA seeks to empower patients to make informed decisions regarding their treatment. The effectiveness of this approach will be evaluated by measuring improvements in knowledge, adherence, and quality of life among participants.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 21 and older who have been diagnosed with hypothyroidism and have had at least two follow-up visits at SingHealth Polyclinics in the past year.
Not a fit: Patients who are euthyroid, experiencing LT4 over-replacement, or have severe illnesses or mental disturbances may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve medication adherence and overall health outcomes for patients with hypothyroidism.
How similar studies have performed: Previous studies have shown that patient decision aids can improve medication adherence in various chronic diseases, indicating a promising potential for this approach in hypothyroidism management.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria
* Age ≥21 years
* Able to read and speak English
* Active patient with hypothyroidism at SingHealth Polyclinics (SHP) {had minimum of 2 follow-up visits at the respective study site in the last 12 months}
* TSH \>3.70 milli-international units per liter (mIU/L)
Exclusion Criteria:
* Euthyroid state (TSH 0.65-3.70 mIU/L)
* LT4 over-replacement (TSH \<0.65 mIU/L)
* Individuals who are severely ill or with hearing impairment and mental disturbances
* Pregnant women
* Sick euthyroid syndrome
Where this trial is running
Singapore
- SingHealth Polyclinics — Singapore, Singapore (Recruiting)
Study contacts
- Principal investigator: Kalaipriya Gunasekaran, MD — SingHealth Polyclinics
- Study coordinator: Kalaipriya Gunasekaran, MD
- Email: kalaipriya.gunasekaran@singhealth.com.sg
- Phone: (65)98071122
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.