Ignite Creation Date:
2024-05-06 @ 7:59 PM
Last Modification Date:
2024-10-26 @ 3:18 PM
Study NCT ID:
NCT06205303
Status:
RECRUITING
Last Update Posted:
2024-04-17
First Post:
2023-12-27
Brief Title:
Interventional Study to Improve Medication Adherence Using Patient Decision Aid
Sponsor:
SingHealth Polyclinics
Organization:
SingHealth Polyclinics
Study Overview
Official Title:
An Interventional Study to Improve Medication Adherence Using Patient Decision Aid Among Adults With Under-Replaced HypoThyroidism IMPART A Randomized Control Study
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IMPART
Brief 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 11 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 37 mIUL within the last 6 months
Relevancesignificance 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
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 11 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 37 mIUL within the last 6 months
Relevancesignificance 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
Detailed Description:
Patient decision aids PDA help people involved in decision making by providing information about the options and outcomes and by clarifying their concerns PDAs will help the patients to participate in decision making through SHARE approach seeking patients participation helping them to explore and compare treatment options assessing their values and preferences reaching a decision with them and evaluating the patients decision Decision aids have the potential to improve adherence by enabling patient-doctor communication on treatment-related factors
PDAs have been shown to improve medication adherence across different chronic diseases like osteoporosis and prevention of coronary heart diseases with aspirin These aids provide patients with valuable information and support helping them make informed choices about their treatment plans and fostering better adherence to prescribed medications Decision Aids are available for managing hyperthyroidism caused by Graves disease but not for hypothyroidism Addressing this gap could greatly empower patients with hypothyroidism to make well-informed choices about their treatment and improve their overall experience with managing this condition
Intervention and theoretical framework According to the Capability Motivation and Opportunity - Behavior COM-B model Capability Motivation and Opportunity are all referred to as components that influence behavior Capability refers to the individuals psychological and physical capacity to engage in the activity concerned while Opportunity refers to all those factors that lie outside the individual that make the behaviour possible or provoke it Motivation includes all those cognitive processes that motivate direct behavior including the habitual processes emotional responding and analytical decision-making Earlier models to improve medication adherence generally highlighted the importance of doctor-patient communication and its impact on patient satisfaction knowledge and ignorance as key determinants of medication adherence However studies on health behavior have constantly shown that merely providing information alone is not an effective strategy to influence behavior like adherence to medication The COM-B model explicitly considers external resources like physical and social environment which are typically not considered in other models like transtheoretical model of behavior change or health belief model Jackson et al considered that COM-B model provided a more comprehensive description of adherence than other existing models making it easier to identify appropriate interventions
Study objectives The aim is to evaluate the acceptance usability understanding and effectiveness of a PDA developed for hypothyroid adults in improving their knowledge beliefs adherence and quality of life in patients with under-replaced hypothyroid status in primary care
Primary objective is
To determine effectiveness of PDA in improving the knowledge beliefs medication adherence and quality of life
Secondary objectives are as follows
i To assess their perceived usability of this PDA ii To assess patients understanding and acceptance on the PDA
Recruitment and consent taking Participant recruitment Eligible patient participants will be referred by the attending physicians to the study team The study team will verify eligibility of shortlisted patients using an eligibility assessment form and written informed consent will be obtained in-person at the study site in a quiet and separate room or space free from intrusion The participant will sign three hardcopies of the consent form One copy each will be kept by the participant study team and the participants electronic medical records Adequate time will be given to read the documents and to ask any questions Assurance will be given that the decision whether to participate is entirely voluntary and will not result in any compromise of their routine clinical care
Participant withdrawal Participants may choose to withdraw from the study at any time without providing an explanation and this will not result in any punitive consequences
Randomization Participants will be randomized to either the intervention arm health education using the PDA or the control arm thyroxine replacement pamphlet during routine clinic appointment in a ratio of 11 using computer-generated random numbers for simple randomization of subjects Patient participants will not be blinded to the allocation status The randomization sequence is written and kept in an opaque sealed envelope which will be labelled with a serial number The study team will open the sealed envelope once the patient has consented to participate and then will be assigned to the intervention arm accordingly
Blinding The nature of the intervention makes impossible to blind patients and research team to participant allocation However treating doctors will be blinded to the allocated group as the intervention session using the PDA will be delivered after their routine clinic appointment and dose titration if required The data analysts will also be blinded to the allocated group before analysis
Follow-up The primary goal of thyroxine replacement is to maintain thyroid hormone levels within a normal range Since TSH responds sensitively to these levels free T4T3 clinical practice guidelines recommend using TSH levels as the primary marker for monitoring thyroxine replacement Hence only TSH will be used to monitor the participants
PDAs have been shown to improve medication adherence across different chronic diseases like osteoporosis and prevention of coronary heart diseases with aspirin These aids provide patients with valuable information and support helping them make informed choices about their treatment plans and fostering better adherence to prescribed medications Decision Aids are available for managing hyperthyroidism caused by Graves disease but not for hypothyroidism Addressing this gap could greatly empower patients with hypothyroidism to make well-informed choices about their treatment and improve their overall experience with managing this condition
Intervention and theoretical framework According to the Capability Motivation and Opportunity - Behavior COM-B model Capability Motivation and Opportunity are all referred to as components that influence behavior Capability refers to the individuals psychological and physical capacity to engage in the activity concerned while Opportunity refers to all those factors that lie outside the individual that make the behaviour possible or provoke it Motivation includes all those cognitive processes that motivate direct behavior including the habitual processes emotional responding and analytical decision-making Earlier models to improve medication adherence generally highlighted the importance of doctor-patient communication and its impact on patient satisfaction knowledge and ignorance as key determinants of medication adherence However studies on health behavior have constantly shown that merely providing information alone is not an effective strategy to influence behavior like adherence to medication The COM-B model explicitly considers external resources like physical and social environment which are typically not considered in other models like transtheoretical model of behavior change or health belief model Jackson et al considered that COM-B model provided a more comprehensive description of adherence than other existing models making it easier to identify appropriate interventions
Study objectives The aim is to evaluate the acceptance usability understanding and effectiveness of a PDA developed for hypothyroid adults in improving their knowledge beliefs adherence and quality of life in patients with under-replaced hypothyroid status in primary care
Primary objective is
To determine effectiveness of PDA in improving the knowledge beliefs medication adherence and quality of life
Secondary objectives are as follows
i To assess their perceived usability of this PDA ii To assess patients understanding and acceptance on the PDA
Recruitment and consent taking Participant recruitment Eligible patient participants will be referred by the attending physicians to the study team The study team will verify eligibility of shortlisted patients using an eligibility assessment form and written informed consent will be obtained in-person at the study site in a quiet and separate room or space free from intrusion The participant will sign three hardcopies of the consent form One copy each will be kept by the participant study team and the participants electronic medical records Adequate time will be given to read the documents and to ask any questions Assurance will be given that the decision whether to participate is entirely voluntary and will not result in any compromise of their routine clinical care
Participant withdrawal Participants may choose to withdraw from the study at any time without providing an explanation and this will not result in any punitive consequences
Randomization Participants will be randomized to either the intervention arm health education using the PDA or the control arm thyroxine replacement pamphlet during routine clinic appointment in a ratio of 11 using computer-generated random numbers for simple randomization of subjects Patient participants will not be blinded to the allocation status The randomization sequence is written and kept in an opaque sealed envelope which will be labelled with a serial number The study team will open the sealed envelope once the patient has consented to participate and then will be assigned to the intervention arm accordingly
Blinding The nature of the intervention makes impossible to blind patients and research team to participant allocation However treating doctors will be blinded to the allocated group as the intervention session using the PDA will be delivered after their routine clinic appointment and dose titration if required The data analysts will also be blinded to the allocated group before analysis
Follow-up The primary goal of thyroxine replacement is to maintain thyroid hormone levels within a normal range Since TSH responds sensitively to these levels free T4T3 clinical practice guidelines recommend using TSH levels as the primary marker for monitoring thyroxine replacement Hence only TSH will be used to monitor the participants
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None