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Interventional Study to Improve Medication Adherence Using Patient Decision Aid

NCT06205303 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 236

Last updated 2026-04-20

No results posted yet for this study

Summary

Background:

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.

Conditions

Interventions

OTHER

Patient Decision Aid (Video)

Patient decision aid on thyroxine replacement is a video designed to assist the hypothyroid adults with under-replacement. It provides clear and balanced information about hypothyroidism, the role of thyroxine, treatment benefits, potential risks, and factors interfering thyroxine absorption and bioavailability. The PDA aims to empower patients to engage in shared decision-making with their healthcare provider, ensuring they understand the options and can make choices aligned with their preferences and values.

Sponsors & Collaborators

  • SingHealth Polyclinics

    lead OTHER

Principal Investigators

  • Kalaipriya Gunasekaran, MD · SingHealth Polyclinics

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-15
Primary Completion
2025-10-06
Completion
2025-10-06

Countries

  • Singapore

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06205303 on ClinicalTrials.gov