Pure Global AI
NCT06410768Enrolling by invitation

Economic Evaluation of a Multistage Shared Decision-making Program for Type 2 Diabetes: a Pilot Study

Evaluating the Feasibility of a Future Trial-based Economic Evaluation of a Multistage Shared Decision-making Program for the Treatment of Type 2 Diabetes Mellitus: a Pilot Study
Maastricht University Medical CenterClinicalTrials.govbehavioral
Study focus
Drug/Device/Intervention
multistage shared decision-making program
Study type
Interventional
Intervention type
behavioral
Sponsor & location
Primary sponsor
Maastricht University Medical Center
Location
Gorinchem, Netherlands
Timeline & enrollment
Phase
N/A
Start date
Feb 01, 2024
End date
May 01, 2025
Enrollment
40 participants
Primary outcome

Sample recruitment,Sample retention,Consent rates,Recruit to target,Age (years),Sex (self-reported questionnaire),Country of birth (self-reported questionnaire),Educational level (self-reported questionnaire),Financial (self-reported questionnaire),Work situation (self-reported questionnaire),Duration of type 2 diabetes (self-reported questionnaire),Weight (kg) (self-reported questionnaire),Height (cm) (self-reported questionnaire),Medication use (self-reported questionnaire),Medication adherence measured with the Medication Adherence Report Scale (MARS),Health literacy (self-reported questionnaire),Study management measured by conducting focus groups with participating healthcare professionals,Patient decisional conflict measured with the decisional conflict scale (DCS),Patient-rated level of shared decision-making measured with the 3-item CollaboRATE survey,Patient-rated level of shared decision-making measured with the SDM-Q-9 questionnaire,Healthcare professional level of shared decision-making measured with the SDM-Q-Doc questionnaire,Patient knowledge measured with tailor-made questions,Glycemic control obtained from general practitioner data,Health-related quality of life measured with the EuroQol (EQ) 5 Dimension (5D) - 5 Level (5L) questionnaire,Medical consumption measured with the iMCQ,Productivity costs measured with the iPCQ,Understandability of measurement tools

Summary

Type 2 diabetes mellitus is a highly prevalent disease, affecting over a million Dutch
 citizens, leading to severe micro- and macrovascular complications, reduced quality of life,
 and high healthcare costs. Clinical guidelines recommend a person-centered approach to
 improve (health)outcomes. However, with rapidly increasing treatment options, both in terms
 of medication and lifestyle interventions, shared decision making (SDM) is challenging in
 practice. Therefore, researchers have developed a multistage SDM program consisting of an
 online patient decision aid for type 2 diabetes mellitus, training for healthcare
 professionals in SDM, and a preparatory consult to provide patients with the knowledge and
 confidence to participate in SDM. Strong evidence of (cost)-effectiveness is a key
 requirement to achieve broad implementation of this program. This pilot study represents an
 important initial step towards high-quality economic evaluation research, with a focus on the
 diversity of the study population, burden on participating healthcare practices, and
 feasibility of outcome measurement.

ICD-10 classifications
Type 2 diabetes mellitusType 2 diabetes mellitus with unspecified complicationsType 2 diabetes mellitus with other specified complicationsType 2 diabetes mellitus without complicationsType 2 diabetes mellitus with multiple complications
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06410768
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06410768 through Pure Global AI's free database. This phase not specified trial is sponsored by Maastricht University Medical Center and is currently Enrolling by invitation. The study focuses on Diabetes Mellitus, Type 2. Target enrollment is 40 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.