Diabetes Mellitus, Type 2NCT06410768

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

A study testing multistage shared decision-making program in people with Diabetes Mellitus, Type 2, run by Maastricht University Medical Center at 1 site in Netherlands.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Diabetes Mellitus, Type 2
What is being tested?: multistage shared decision-making program
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 1 siteNetherlands
Study dates: 1 Feb 2024to 1 May 2025
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Is diagnosed with type 2 diabetes mellitus
Eighteen years or older
Need to decide on type 2 diabetes treatment based on the national guidelines
Multiple treatment options (medication and/or lifestyle) are possible as judged by the healthcare professional
Speak Dutch at a necessary level to complete questionnaires and ensure involvement in shared decision-making

Who cannot join

Severe cognitive impairments that hamper shared decision-making

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

Care group Huisarts & Zorg
Gorinchem

Other trials in Netherlands

About this study

Official title: 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

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.

Read the detailed description

Rationale: Previous randomized controlled trials researching the effects of shared decision-making (SDM) support through patient decision aids (PDAs) for type 2 diabetes mellitus (T2DM) experienced several challenges related to study procedures, resources, and study management. These challenges include difficulties in recruiting participants, understandability of questionnaires, timely recruitment, and inadvertent recruitment bias. Small-scale piloting is crucial to address uncertainties around the feasibility of trial methods and to refine the study procedures of a large-scale economic evaluation. This protocol outlines a pilot study aimed at evaluating the feasibility of a future trial-based economic evaluation of a multistage SDM program, including a PDA for T2DM in the Netherlands. By conducting a pilot study, the researchers aim to improve the quality of the intended trial-based economic evaluation.

Objectives: Researchers will conduct a pilot study focused on the following questions to prepare for an intended economic evaluation of our multistage SDM program for T2DM: 1) How to recruit and retain a representative sample of patients with T2DM in terms of sociodemographic and clinical background?; 2) How to support primary care practices in managing the challenges associated with study participation?; 3) How to feasibly measure relevant outcomes of SDM for T2DM using valid and reliable measurement instruments?

Study design: The multistage SDM program will be piloted in a cluster-randomized controlled trial using a mixed-methods approach. Four primary care practices will be included, of which two will be randomly assigned to the intervention group and two to the control group.

Conditions: Diabetes Mellitus, Type 2
Being tested: multistage shared decision-making program
Keywords: type 2 diabetes mellitus, person-centered care, shared decision-making, pilot study, patient decision aid, economic evaluation
Medical subject headings: Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

multistage shared decision-making programBehavioural
The multistage shared decision-making program consists of 1) an online patient decision aid; 2) preparatory consult to provide patients with the knowledge and confidence to participate in shared decision-making; and 3) training to improve healthcare professionals' skills for shared decision-making.

Study groups in NCT06410768
Study group	Role	What they receive
Intervention	Other	The intervention entails a multistage shared decision-making (SDM) program for type 2 diabetes mellitus (T2DM) that combines (1) an online PDA with (2) a preparatory consult for patients, and (3) interprofessional training in the PDA and SDM for healthcare professionals. Receives: Behavioral: multistage shared decision-making program
Control	No intervention	Patients and healthcare professionals in the control practices will provide and receive usual care according to the national guidelines for T2DM of the Dutch College of General Practitioners (NHG). Participants in the control practices will not have access to the multistage SDM program.

What is being measured

The primary outcome is the main question the study is designed to answer.

Sample recruitment
Recruitment rates: how many patients were recruited on average for one month at one location.
Time required to recruit to the target Sociodemographic and clinical characteristics
Measured: 9 months
Sample retention
Retention rates: percentage of participants who completed the study
Measured: 9 months
Consent rates
Consent rates: number of patients enrolled divided by number of eligible patients
Measured: 9 months
Recruit to target
Time required to recruit to target sample size
Measured: 9 months
Age (years)
Age of participating patients in years. Patients are asked to complete a questionnaire at baseline that includes a question regarding their age.
Measured: Measured at baseline
Sex (self-reported questionnaire)
Sex of participating patients. Patients are asked to complete a questionnaire at baseline that includes a question regarding their sex.
Measured: Measured at baseline
Country of birth (self-reported questionnaire)
Country of birth of participating patients. Patients are asked to complete a questionnaire at baseline that includes a question regarding their country of birth.
Measured: Measured at baseline
Educational level (self-reported questionnaire)
Educational level of participating patients. Patients are asked to complete a questionnaire at baseline that includes a question regarding their highest received diploma.
Measured: Measured at baseline
Financial (self-reported questionnaire)
Make ends meet financially of participating patients. Patients are asked to complete a questionnaire at baseline that includes a question regarding their financial situation (i.e. whether they have (not) difficulties in making ends meet financially)
Measured: Measured at baseline
Work situation (self-reported questionnaire)
Work situation of participating patients. Patients are asked to complete a questionnaire at baseline that includes a question regarding their work situation.
Measured: Measured at baseline
Duration of type 2 diabetes (self-reported questionnaire)
Duration of diabetes of participating patients. Patients are asked to complete a questionnaire at baseline that includes a question regarding how many years they have type 2 diabetes.
Measured: Measured at baseline
Weight (kg) (self-reported questionnaire)
Weight of participating patients in kg. Patients are asked to complete a questionnaire at baseline that includes a question regarding what their weight in kg is. This measure is used, in combination with height, to calculate their BMI.
Measured: Measured at baseline
Height (cm) (self-reported questionnaire)
Height of participating patients in kg. Patients are asked to complete a questionnaire at baseline that includes a question regarding what their height in cm is. This measure is used, in combination with weight, to calculate their BMI.
Measured: Measured at baseline
Medication use (self-reported questionnaire)
Medication use of participating patients in kg. Patients are asked to complete a questionnaire at baseline that includes a question regarding whether they use medication, and if so, whether they take oral medication or inject insulin.
Measured: Measured at baseline
Medication adherence measured with the Medication Adherence Report Scale (MARS)
Medication adherence measured with the Medication Adherence Report Scale (MARS) test. This test contains six statements regarding medication adherence and patients are asked to indicate whether the statements applies to them on a five point Likert Scale. Patients are asked to complete this test at baseline, 3 months and 9 months follow-up.
Measured: Baseline, 3-months and 9-months follow-up
Health literacy (self-reported questionnaire)
Health literacy of participating patients measured with the shortened version of the European Health Literacy Survey questionnaire (HLS-EU) Dutch questionnaire (6 questions)
Measured: Measured at baseline
Study management measured by conducting focus groups with participating healthcare professionals
Assessment of primary care practices' study management challenges (i.e. time constraints and capacity issues). This will be assessed by conducting focus groups with healthcare professionals from the participating general practices.
Measured: Focus groups will be held at the end of patient inclusion period, 9-months
Patient decisional conflict measured with the decisional conflict scale (DCS)
Decisional conflict measured with the 16-item decisional conflict scale (DCS). Patients will be asked to reflect on the treatment decision they made with their healthcare professional and respond to 16 statements in the DCS using a five-point Likert scale (ranging from completely agree to completely disagree). Besides a total score, the DCS includes five dimensions (i.e. information, support, clarification or values, certainty, and decision quality) with higher scores on a five-point scale indicating more decisional conflict. Patients are asked to complete this questionnaire at baseline, 3 months and 9 months follow-up.
Measured: Throughout implementation period, 9-months
Patient-rated level of shared decision-making measured with the 3-item CollaboRATE survey
Patient-rated level of shared decision-making is measured by the 3-item CollaboRATE survey. The CollaboRATE survey assesses patients' perception of being informed and engaged in the decision-making steps on a scale of zero (no effort was made) to nine (every effort was made). Patients are asked to complete this questionnaire at baseline, 3 months and 9 months follow-up.
Measured: Throughout implementation period, 9-months
Patient-rated level of shared decision-making measured with the SDM-Q-9 questionnaire
Patient-rated level of shared decision-making is measured by the SDM-Q-9 questionnaire. The SDM-Q-9 questionnaire measures the extent of shared decision-making durin a consultation between the patient and healthcare professional. This questionnaire consists of nine statements each describing a different step of the shared decision-making process. All items are scored on a six-point Likert scale from zero (completely disagree) to five (completely agree).
Measured: Throughout implementation period, 9-months
Healthcare professional level of shared decision-making measured with the SDM-Q-Doc questionnaire
The SDM Q-Doc questionnaire (SDM-Q-9 adapted to the healthcare professional viewpoint) is used to measure the level of shared decision-making during a consultation from the perspective of a healthcare professional.
Measured: Throughout implementation period, 9-months
Patient knowledge measured with tailor-made questions
Patient knowledge is measured with nine tailor-made multiple-choice questions assessing patients' understanding of the (risks and benefits of) glucose-lowering treatments.
Measured: Measured at baseline
Glycemic control obtained from general practitioner data
Glycemic control of participating patients will be obtained by obtaining HbA1c data from the general practitioner
Measured: Baseline, 3-months and 9-months follow-up
Health-related quality of life measured with the EuroQol (EQ) 5 Dimension (5D) - 5 Level (5L) questionnaire
Health-related quality of life of participating patients will be measured with the Dutch EuroQol (EQ) 5 Dimension (5D) - 5 Level (5L) This measure facilitates utility calculations and includes the EQ-5D dimension and the EQ visual analog scale (EQ VAS). EQ-5D comprises five dimensions: mobility, self-care, pain, usual activities and anxiety. Each dimension is scored on a five-point Likert score (from no problems to extreme problems). The EQ VAS is used to assess the patient's self-reported health on a visual analog scale.
Measured: Baseline, 3-months and 9-months follow-up
Medical consumption measured with the iMCQ
Medical consumption will be measured with an adapted version of the institute for Medical technology Assessment (iMTA) Medical Consumption Questionnaire (iMCQ).
Measured: Baseline, 3-months and 9-months follow-up
Productivity costs measured with the iPCQ
Productivity costs will be measured with an adapted version of the institute for Medical technology Assessment (iMTA) Productivity Costs Questionnaire (iPCQ).
Measured: Baseline, 3-months and 9-months follow-up
Understandability of measurement tools
Sem-structured interviews with patients will be held to gain insight into the understandability of the measurement tools.
Measured: Throughout the 9-month implementation period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Feb 20241 May 2025

First posted13 May 2024
Study start1 Feb 2024
Primary completion1 Nov 2024 (estimated)
Study completion1 May 2025 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (19)Papers the sponsor has linked to this study.
Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 40 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06410768
Sponsor's protocol ID: METC2023-0114
Status last verified: May 2024
First submitted: 22 Apr 2024
Last updated: 13 May 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: The study protocol will be made publicly available as a research article in a scientific journal. The protocol is under review.

Publications

Elwyn G, O'Connor A, Stacey D, Volk R, Edwards A, Coulter A, Thomson R, Barratt A, Barry M, Bernstein S, Butow P, Clarke A, Entwistle V, Feldman-Stewart D, Holmes-Rovner M, Llewellyn-Thomas H, Moumjid N, Mulley A, Ruland C, Sepucha K, Sykes A, Whelan T; International Patient Decision Aids Standards (IPDAS) Collaboration. Developing a quality criteria framework for patient decision aids: online international Delphi consensus process. BMJ. 2006 Aug 26;333(7565):417. doi: 10.1136/bmj.38926.629329.AE. Epub 2006 Aug 14.
PubMed 16908462
ElSayed NA, Aleppo G, Aroda VR, Bannuru RR, Brown FM, Bruemmer D, Collins BS, Hilliard ME, Isaacs D, Johnson EL, Kahan S, Khunti K, Leon J, Lyons SK, Perry ML, Prahalad P, Pratley RE, Seley JJ, Stanton RC, Gabbay RA, on behalf of the American Diabetes Association. 9. Pharmacologic Approaches to Glycemic Treatment: Standards of Care in Diabetes-2023. Diabetes Care. 2023 Jan 1;46(Suppl 1):S140-S157. doi: 10.2337/dc23-S009.
PubMed 36507650
Davies MJ, Aroda VR, Collins BS, Gabbay RA, Green J, Maruthur NM, Rosas SE, Del Prato S, Mathieu C, Mingrone G, Rossing P, Tankova T, Tsapas A, Buse JB. Management of hyperglycaemia in type 2 diabetes, 2022. A consensus report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetologia. 2022 Dec;65(12):1925-1966. doi: 10.1007/s00125-022-05787-2. Epub 2022 Sep 24.
PubMed 36151309
Institute of Medicine (US) Committee on Quality of Health Care in America. Crossing the Quality Chasm: A New Health System for the 21st Century. Washington (DC): National Academies Press (US); 2001. Available from http://www.ncbi.nlm.nih.gov/books/NBK222274/
PubMed 25057539
Stacey D, Legare F, Col NF, Bennett CL, Barry MJ, Eden KB, Holmes-Rovner M, Llewellyn-Thomas H, Lyddiatt A, Thomson R, Trevena L, Wu JH. Decision aids for people facing health treatment or screening decisions. Cochrane Database Syst Rev. 2014 Jan 28;(1):CD001431. doi: 10.1002/14651858.CD001431.pub4.
PubMed 24470076
Stacey D, Suwalska V, Boland L, Lewis KB, Presseau J, Thomson R. Are Patient Decision Aids Used in Clinical Practice after Rigorous Evaluation? A Survey of Trial Authors. Med Decis Making. 2019 Oct;39(7):805-815. doi: 10.1177/0272989X19868193. Epub 2019 Aug 17.
PubMed 31423911
Kellar I, Mann E, Kinmonth AL, Prevost AT, Sutton S, Marteau TM. Can informed choice invitations lead to inequities in intentions to make lifestyle changes among participants in a primary care diabetes screening programme? Evidence from a randomized trial. Public Health. 2011 Sep;125(9):645-52. doi: 10.1016/j.puhe.2011.05.010. Epub 2011 Jul 20.
PubMed 21764087
Branda ME, LeBlanc A, Shah ND, Tiedje K, Ruud K, Van Houten H, Pencille L, Kurland M, Yawn B, Montori VM. Shared decision making for patients with type 2 diabetes: a randomized trial in primary care. BMC Health Serv Res. 2013 Aug 8;13:301. doi: 10.1186/1472-6963-13-301.
PubMed 23927490
Mathers N, Ng CJ, Campbell MJ, Colwell B, Brown I, Bradley A. Clinical effectiveness of a patient decision aid to improve decision quality and glycaemic control in people with diabetes making treatment choices: a cluster randomised controlled trial (PANDAs) in general practice. BMJ Open. 2012 Nov 5;2(6):e001469. doi: 10.1136/bmjopen-2012-001469. Print 2012.
PubMed 23129571
Mullan RJ, Montori VM, Shah ND, Christianson TJ, Bryant SC, Guyatt GH, Perestelo-Perez LI, Stroebel RJ, Yawn BP, Yapuncich V, Breslin MA, Pencille L, Smith SA. The diabetes mellitus medication choice decision aid: a randomized trial. Arch Intern Med. 2009 Sep 28;169(17):1560-8. doi: 10.1001/archinternmed.2009.293.
PubMed 19786674
Thabane L, Ma J, Chu R, Cheng J, Ismaila A, Rios LP, Robson R, Thabane M, Giangregorio L, Goldsmith CH. A tutorial on pilot studies: the what, why and how. BMC Med Res Methodol. 2010 Jan 6;10:1. doi: 10.1186/1471-2288-10-1.
PubMed 20053272
van Teijlingen E, Hundley V. The importance of pilot studies. Nurs Stand. 2002 Jun 19-25;16(40):33-6. doi: 10.7748/ns2002.06.16.40.33.c3214.
PubMed 12216297
Black SA. Diabetes, diversity, and disparity: what do we do with the evidence? Am J Public Health. 2002 Apr;92(4):543-8. doi: 10.2105/ajph.92.4.543.
PubMed 11919048
Brodaty H, Gibson LH, Waine ML, Shell AM, Lilian R, Pond CD. Research in general practice: a survey of incentives and disincentives for research participation. Ment Health Fam Med. 2013 Sep;10(3):163-73.
PubMed 24427184
McKinley N, McCain RS, Convie L, Clarke M, Dempster M, Campbell WJ, Kirk SJ. Resilience, burnout and coping mechanisms in UK doctors: a cross-sectional study. BMJ Open. 2020 Jan 27;10(1):e031765. doi: 10.1136/bmjopen-2019-031765.
PubMed 31988223

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 13 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT06410768
Acronym / sponsor ID: METC2023-0114
Conditions: Diabetes Mellitus, Type 2
Keywords: type 2 diabetes mellitus, person-centered care, shared decision-making, pilot study, patient decision aid, economic evaluation
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 40 participants (estimated)
Lead sponsor: Maastricht University Medical CenterUniversity, hospital or other
Collaborators: Maastricht University
Study start: 1 Feb 2024 (actual)
Primary completion: 1 Nov 2024 (estimated)
Study completion: 1 May 2025 (estimated)
First posted: 13 May 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Intervention	Other	Behavioral: multistage shared decision-making programThe intervention entails a multistage shared decision-making (SDM) program for type 2 diabetes mellitus (T2DM) that combines (1) an online PDA with (2) a preparatory consult for patients, and (3) interprofessional training in the PDA and SDM for healthcare professionals.
Control	No intervention	–Patients and healthcare professionals in the control practices will provide and receive usual care according to the national guidelines for T2DM of the Dutch College of General Practitioners (NHG). Participants in the control practices will not have access to the multistage SDM program.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Is diagnosed with type 2 diabetes mellitus
Eighteen years or older
Need to decide on type 2 diabetes treatment based on the national guidelines
Multiple treatment options (medication and/or lifestyle) are possible as judged by the healthcare professional
Speak Dutch at a necessary level to complete questionnaires and ensure involvement in shared decision-making

Key exclusion criteria (1 listed)

Severe cognitive impairments that hamper shared decision-making

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
multistage shared decision-making programThe multistage shared decision-making program consists of 1) an online patient decision aid; 2) preparatory consult to provide patients with the knowledge and confidence to participate in shared decision-making; and 3) training to improve healthcare professionals' skills for shared decision-making.	Behavioural	Intervention

Primary outcome

Sample recruitment
Time frame: 9 months
Recruitment rates: how many patients were recruited on average for one month at one location. Time required to recruit to the target Sociodemographic and clinical characteristics
Sample retention
Time frame: 9 months
Retention rates: percentage of participants who completed the study
Consent rates
Time frame: 9 months
Consent rates: number of patients enrolled divided by number of eligible patients
Recruit to target
Time frame: 9 months
Time required to recruit to target sample size
Age (years)
Time frame: Measured at baseline
Age of participating patients in years. Patients are asked to complete a questionnaire at baseline that includes a question regarding their age.
Sex (self-reported questionnaire)
Time frame: Measured at baseline
Sex of participating patients. Patients are asked to complete a questionnaire at baseline that includes a question regarding their sex.
Country of birth (self-reported questionnaire)
Time frame: Measured at baseline
Country of birth of participating patients. Patients are asked to complete a questionnaire at baseline that includes a question regarding their country of birth.
Educational level (self-reported questionnaire)
Time frame: Measured at baseline
Educational level of participating patients. Patients are asked to complete a questionnaire at baseline that includes a question regarding their highest received diploma.
Financial (self-reported questionnaire)
Time frame: Measured at baseline
Make ends meet financially of participating patients. Patients are asked to complete a questionnaire at baseline that includes a question regarding their financial situation (i.e. whether they have (not) difficulties in making ends meet financially)
Work situation (self-reported questionnaire)
Time frame: Measured at baseline
Work situation of participating patients. Patients are asked to complete a questionnaire at baseline that includes a question regarding their work situation.
Duration of type 2 diabetes (self-reported questionnaire)
Time frame: Measured at baseline
Duration of diabetes of participating patients. Patients are asked to complete a questionnaire at baseline that includes a question regarding how many years they have type 2 diabetes.
Weight (kg) (self-reported questionnaire)
Time frame: Measured at baseline
Weight of participating patients in kg. Patients are asked to complete a questionnaire at baseline that includes a question regarding what their weight in kg is. This measure is used, in combination with height, to calculate their BMI.
Height (cm) (self-reported questionnaire)
Time frame: Measured at baseline
Height of participating patients in kg. Patients are asked to complete a questionnaire at baseline that includes a question regarding what their height in cm is. This measure is used, in combination with weight, to calculate their BMI.
Medication use (self-reported questionnaire)
Time frame: Measured at baseline
Medication use of participating patients in kg. Patients are asked to complete a questionnaire at baseline that includes a question regarding whether they use medication, and if so, whether they take oral medication or inject insulin.
Medication adherence measured with the Medication Adherence Report Scale (MARS)
Time frame: Baseline, 3-months and 9-months follow-up
Medication adherence measured with the Medication Adherence Report Scale (MARS) test. This test contains six statements regarding medication adherence and patients are asked to indicate whether the statements applies to them on a five point Likert Scale. Patients are asked to complete this test at baseline, 3 months and 9 months follow-up.
Health literacy (self-reported questionnaire)
Time frame: Measured at baseline
Health literacy of participating patients measured with the shortened version of the European Health Literacy Survey questionnaire (HLS-EU) Dutch questionnaire (6 questions)
Study management measured by conducting focus groups with participating healthcare professionals
Time frame: Focus groups will be held at the end of patient inclusion period, 9-months
Assessment of primary care practices' study management challenges (i.e. time constraints and capacity issues). This will be assessed by conducting focus groups with healthcare professionals from the participating general practices.
Patient decisional conflict measured with the decisional conflict scale (DCS)
Time frame: Throughout implementation period, 9-months
Decisional conflict measured with the 16-item decisional conflict scale (DCS). Patients will be asked to reflect on the treatment decision they made with their healthcare professional and respond to 16 statements in the DCS using a five-point Likert scale (ranging from completely agree to completely disagree). Besides a total score, the DCS includes five dimensions (i.e. information, support, clarification or values, certainty, and decision quality) with higher scores on a five-point scale indicating more decisional conflict. Patients are asked to complete this questionnaire at baseline, 3 months and 9 months follow-up.
Patient-rated level of shared decision-making measured with the 3-item CollaboRATE survey
Time frame: Throughout implementation period, 9-months
Patient-rated level of shared decision-making is measured by the 3-item CollaboRATE survey. The CollaboRATE survey assesses patients' perception of being informed and engaged in the decision-making steps on a scale of zero (no effort was made) to nine (every effort was made). Patients are asked to complete this questionnaire at baseline, 3 months and 9 months follow-up.
Patient-rated level of shared decision-making measured with the SDM-Q-9 questionnaire
Time frame: Throughout implementation period, 9-months
Patient-rated level of shared decision-making is measured by the SDM-Q-9 questionnaire. The SDM-Q-9 questionnaire measures the extent of shared decision-making durin a consultation between the patient and healthcare professional. This questionnaire consists of nine statements each describing a different step of the shared decision-making process. All items are scored on a six-point Likert scale from zero (completely disagree) to five (completely agree).
Healthcare professional level of shared decision-making measured with the SDM-Q-Doc questionnaire
Time frame: Throughout implementation period, 9-months
The SDM Q-Doc questionnaire (SDM-Q-9 adapted to the healthcare professional viewpoint) is used to measure the level of shared decision-making during a consultation from the perspective of a healthcare professional.
Patient knowledge measured with tailor-made questions
Time frame: Measured at baseline
Patient knowledge is measured with nine tailor-made multiple-choice questions assessing patients' understanding of the (risks and benefits of) glucose-lowering treatments.
Glycemic control obtained from general practitioner data
Time frame: Baseline, 3-months and 9-months follow-up
Glycemic control of participating patients will be obtained by obtaining HbA1c data from the general practitioner
Health-related quality of life measured with the EuroQol (EQ) 5 Dimension (5D) - 5 Level (5L) questionnaire
Time frame: Baseline, 3-months and 9-months follow-up
Health-related quality of life of participating patients will be measured with the Dutch EuroQol (EQ) 5 Dimension (5D) - 5 Level (5L) This measure facilitates utility calculations and includes the EQ-5D dimension and the EQ visual analog scale (EQ VAS). EQ-5D comprises five dimensions: mobility, self-care, pain, usual activities and anxiety. Each dimension is scored on a five-point Likert score (from no problems to extreme problems). The EQ VAS is used to assess the patient's self-reported health on a visual analog scale.
Medical consumption measured with the iMCQ
Time frame: Baseline, 3-months and 9-months follow-up
Medical consumption will be measured with an adapted version of the institute for Medical technology Assessment (iMTA) Medical Consumption Questionnaire (iMCQ).
Productivity costs measured with the iPCQ
Time frame: Baseline, 3-months and 9-months follow-up
Productivity costs will be measured with an adapted version of the institute for Medical technology Assessment (iMTA) Productivity Costs Questionnaire (iPCQ).
Understandability of measurement tools
Time frame: Throughout the 9-month implementation period
Sem-structured interviews with patients will be held to gain insight into the understandability of the measurement tools.

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2024.
Background: PubMed 16908462Elwyn G, O'Connor A, Stacey D, Volk R, Edwards A, Coulter A, Thomson R, Barratt A, Barry M, Bernstein S, Butow P, Clarke A, Entwistle V, Feldman-Stewart D, Holmes-Rovner M, Llewellyn-Thomas H, Moumjid N, Mulley A, Ruland C, Sepucha K, Sykes A, Whelan T; International Patient Decision Aids Standards (IPDAS) Collaboration. Developing a quality criteria framework for patient decision aids: online international Delphi consensus process. BMJ. 2006 Aug 26;333(7565):417. doi: 10.1136/bmj.38926.629329.AE. Epub 2006 Aug 14.
Background: PubMed 36507650ElSayed NA, Aleppo G, Aroda VR, Bannuru RR, Brown FM, Bruemmer D, Collins BS, Hilliard ME, Isaacs D, Johnson EL, Kahan S, Khunti K, Leon J, Lyons SK, Perry ML, Prahalad P, Pratley RE, Seley JJ, Stanton RC, Gabbay RA, on behalf of the American Diabetes Association. 9. Pharmacologic Approaches to Glycemic Treatment: Standards of Care in Diabetes-2023. Diabetes Care. 2023 Jan 1;46(Suppl 1):S140-S157. doi: 10.2337/dc23-S009.
Background: PubMed 36151309Davies MJ, Aroda VR, Collins BS, Gabbay RA, Green J, Maruthur NM, Rosas SE, Del Prato S, Mathieu C, Mingrone G, Rossing P, Tankova T, Tsapas A, Buse JB. Management of hyperglycaemia in type 2 diabetes, 2022. A consensus report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetologia. 2022 Dec;65(12):1925-1966. doi: 10.1007/s00125-022-05787-2. Epub 2022 Sep 24.
Background: PubMed 25057539Institute of Medicine (US) Committee on Quality of Health Care in America. Crossing the Quality Chasm: A New Health System for the 21st Century. Washington (DC): National Academies Press (US); 2001. Available from http://www.ncbi.nlm.nih.gov/books/NBK222274/
Background: PubMed 24470076Stacey D, Legare F, Col NF, Bennett CL, Barry MJ, Eden KB, Holmes-Rovner M, Llewellyn-Thomas H, Lyddiatt A, Thomson R, Trevena L, Wu JH. Decision aids for people facing health treatment or screening decisions. Cochrane Database Syst Rev. 2014 Jan 28;(1):CD001431. doi: 10.1002/14651858.CD001431.pub4.
Background: PubMed 31423911Stacey D, Suwalska V, Boland L, Lewis KB, Presseau J, Thomson R. Are Patient Decision Aids Used in Clinical Practice after Rigorous Evaluation? A Survey of Trial Authors. Med Decis Making. 2019 Oct;39(7):805-815. doi: 10.1177/0272989X19868193. Epub 2019 Aug 17.
Background: PubMed 21764087Kellar I, Mann E, Kinmonth AL, Prevost AT, Sutton S, Marteau TM. Can informed choice invitations lead to inequities in intentions to make lifestyle changes among participants in a primary care diabetes screening programme? Evidence from a randomized trial. Public Health. 2011 Sep;125(9):645-52. doi: 10.1016/j.puhe.2011.05.010. Epub 2011 Jul 20.
Background: PubMed 23927490Branda ME, LeBlanc A, Shah ND, Tiedje K, Ruud K, Van Houten H, Pencille L, Kurland M, Yawn B, Montori VM. Shared decision making for patients with type 2 diabetes: a randomized trial in primary care. BMC Health Serv Res. 2013 Aug 8;13:301. doi: 10.1186/1472-6963-13-301.
Background: PubMed 23129571Mathers N, Ng CJ, Campbell MJ, Colwell B, Brown I, Bradley A. Clinical effectiveness of a patient decision aid to improve decision quality and glycaemic control in people with diabetes making treatment choices: a cluster randomised controlled trial (PANDAs) in general practice. BMJ Open. 2012 Nov 5;2(6):e001469. doi: 10.1136/bmjopen-2012-001469. Print 2012.
Background: PubMed 19786674Mullan RJ, Montori VM, Shah ND, Christianson TJ, Bryant SC, Guyatt GH, Perestelo-Perez LI, Stroebel RJ, Yawn BP, Yapuncich V, Breslin MA, Pencille L, Smith SA. The diabetes mellitus medication choice decision aid: a randomized trial. Arch Intern Med. 2009 Sep 28;169(17):1560-8. doi: 10.1001/archinternmed.2009.293.
Background: PubMed 20053272Thabane L, Ma J, Chu R, Cheng J, Ismaila A, Rios LP, Robson R, Thabane M, Giangregorio L, Goldsmith CH. A tutorial on pilot studies: the what, why and how. BMC Med Res Methodol. 2010 Jan 6;10:1. doi: 10.1186/1471-2288-10-1.
Background: PubMed 12216297van Teijlingen E, Hundley V. The importance of pilot studies. Nurs Stand. 2002 Jun 19-25;16(40):33-6. doi: 10.7748/ns2002.06.16.40.33.c3214.
Individual participant dataSharing planned: Yes. The study protocol will be made publicly available as a research article in a scientific journal. The protocol is under review.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Arianne Elissen, PhD principal investigator

Maastricht University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing multistage shared decision-making program in people with Diabetes Mellitus, Type 2, run by Maastricht University Medical Center at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 13 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sample recruitment (time frame: 9 months). The study lists 27 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06410768, which also lists 19 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2024.