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Interventional Study to Improve Medication Adherence Using Patient Decision Aid

Key facts

Who runs it
SingHealth Polyclinics
Where
Singapore1 site in 1 countryChoose a country to see its sites
Trial code
Status
Completed
People taking part
236 people enrolled
Started
15 Mar 2024
Ended
6 Oct 2025
Type of study
Interventional, 2 groupsOne group gets no study treatment, for comparison.
Treatments tested
  • Patient Decision Aid (Video)
Record updated
20 April 2026

Who can take part

Age
21 years and older
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

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Who can take part

  • 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)

Who cannot take part

  • Individuals who are severely ill or with hearing impairment and mental disturbances
  • Sick euthyroid syndrome
  • Euthyroid state (TSH 0.65-3.70 mIU/L)
  • LT4 over-replacement (TSH <0.65 mIU/L)
  • Pregnant women

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

Background:

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Although hypothyroidism is easily treated with levothyroxine (LT4) replacement, results from several studies indicate that people receiving LT4 replacement often have under- or over-replaced thyroid function. Poor medication adherence and factors interfering with thyroxine absorption and bioavailability may result in such under-replacement. Using the COM-B (Capability, Motivation, and Opportunity - Behavior) model, a health education intervention using patient decision aid (PDA), was developed for primary care physicians to educate individuals about thyroxine replacement. Besides imparting health literacy, PDAs provide greater comfort of the patients to participate in decision making. Intervention with the PDA aims to improve the medication adherence by increasing patients' knowledge about thyroxine replacement.

Specific aims: The primary aim is to determine effectiveness of PDA in improving the knowledge, medication adherence and quality of life of the under-replaced hypothyroid adults in a primary care setting. Secondary aims are to explore their understanding and acceptance on the PDA and to assess their perceived usability of this PDA.

Methodology: A randomised controlled trial will be conducted at SingHealth Polyclinics (SHP) using mixed-method study design to determine effectiveness of PDA. Patient participants will be randomly allocated in a 1:1 ratio to either the intervention or control group. A total of 236 (118 in each group) patient participants will be enrolled by simple randomization. Eligible patient must be of age ≥21 years years and have LT4 under-replacement with Thyroid stimulating hormone (TSH) >3.7 mIU/L within the last 6 months.

Relevance/significance of the study: Findings from the study may add evidence to the scientific knowledge of using PDA to improve medication adherence and recommend development of similar interventions for other chronic medical conditions.

The 2 groups in the trial

  • intervention arm using PDATreatment being tested

    The intervention arm participants will watch the PDA which is estimated to take 10 minutes, after their consultation with the physician. The participants will be directed to a private room to watch the PDA.

    Treatment: Patient Decision Aid (Video)

  • Control armNo study treatment, for comparison

    The control arm participants will receive a thyroxine replacement pamphlet at their routine clinic appointment but will not attend the health education session using the PDA.

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
An Interventional Study to Improve Medication Adherence Using Patient Decision Aid Among Adults With Under-Replaced HypoThyroidism (IMPART): A Randomized Control Study
Record updated
20 April 2026