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The goal of this clinical study is to assess differences in collaborative efforts to make care fit between clinical encounters in usual care and those using the Making Care Fit tool among young adults with type 1 diabetes and their clinicians.
The main question it aims to answer is:
What are the differences in collaborative efforts to make care fit between clinical encounters in usual care and those using the Making Care Fit tool?
Researchers will compare clinical encounters in usual care with encounters supported by the Making Care Fit tool to examine differences in collaborative efforts to align care and daily life.
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Care as usual | Other |
| |
| Make Care Fit tool | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Making Care Fit tool | Behavioral | A web-based tool designed to help young adults with type 1 diabetes prepare for care plan design during their clinical encounter by structuring and prioritizing their experiences and efforts in making care fit. |
| Measure | Description | Time Frame |
|---|---|---|
| Observable efforts of collaboration to align care and life, with and without using the tool. | Qualitative coding of observations | 1 month from enrollment to the consultation |
| Perceived and unobservable efforts to align care and life. | Qualitative coding | 2 months from enrollment into the study to the video stimulated interview |
| Perceived alignment of care plan and life. | Young adults & clinicians: Open-ended question: "why does your care plan make sense?" | 4 months from enrollment to filling out the last questionnaire |
| Measure | Description | Time Frame |
|---|---|---|
| Variety and quality of themes discussed | Quantitative coding of observations, self-developed | 1 month from enrollment to consultation |
| Collaborative care plan design | SDMo (reported on 1-10 scale) with higher scores suggesting more collaborative behaviours |
| Measure | Description | Time Frame |
|---|---|---|
| Consultation characteristics | Encounter duration, diabetes clinic, consultation type (in-person or digital) | 1 month from enrollment to consultation |
| Diabetes-specific characteristics | 8 items (self-developed): Treatment regime, year of diagnosis, events of ketoacidosis and hypoglycaemia, HbA1c. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marleen Kunneman, PhD | Contact | 0715263967 | Kunneman@lumc.nl |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Leiden University Medical Center | Leiden | South Holland | 2333ZA | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41645388 | Background | Van Gastel A, Graner-Baars M, De Koning EJP, Montori VM, Tran VT, Dinneen SF, Mesman J, Swaak J, Aanstoot HJ, Stiggelbout AM, Kunneman M. Picture living with diabetes: A photovoice study of young adults' efforts in making diabetes care fit into their lives. Diabet Med. 2026 May;43(5):e70246. doi: 10.1111/dme.70246. Epub 2026 Feb 5. |
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As this is a qualitative study data from participants might be easy traced back to the individuals.
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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This is a multi-center clinical study using a mixed methods parallel group design. Young adults with type 1 diabetes are assigned to either usual care or care supported by the finalized Making Care Fit tool (MCF tool). Clinical encounters are observed and assessed to compare collaborative efforts to align care with daily life between the two groups.
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|
| Care as usual | Other | Participants receive standard diabetes care at their clinic. Clinical encounters are observed and assessed to compare collaborative efforts with those in the Making Care Fit Tool arm. |
|
| 1 month from enrollment to consultation |
| Fidelity of the use of the Making Care Fit tool | Quantitative coding of observations, self-developed | 1 month from enrollment to the consultation |
| Unhurried conversations | Unhurried Collaboration Assessment Tool (UCAT), 37 items to be scored on a 1-5 scale. | 1 month from enrollment to consultation |
| Perceived treatment burden, and acceptability of this burden. | Young adults: Treatment Burden Questionnaire (TBQ), 15 items to be scored on a 0-10 scale; 1 item on acceptability of burden. | 4 months from enrollment to filling out the last questionnaire |
| Perceived diabetes distress | Young adults: Diabetes distress scale (DDS) screening instrument, 2 items to be scored on a 1-6 scale. | 4 months from enrollment to filling out the last questionnaire |
| Self-reported fidelity of using the Making Care Fit tool outside of the clinical encounter | Young adults & clinicians: 3 items about fidelity and and acceptability | 1 month from enrollment to concluding the consultation |
| Perceived clinical empathy | Young adults: Consultation And Relational Empathy (CARE) measure, 10 items to be scored on a 1-5 scale. | 1 month from enrollment to after the consultation |
| Written information by patient in making care fit tool | Qualitative coding | 1 month from enrollment to having the consultation |
| patient involvement | OPTION12 (reported on 0-100 scale) with a higher score being more patient involvement | 1 month after enrollment during the clinical consultation |
| 4 months from enrollment to last questionnaire filled out |
| Consultation characteristic | 1 item (self-developed: Duration of patient/clinician relationship in years | 4 months from enrollment to last questionnaire |
| Work-related characteristics | 2 items (self-developed): Clinicians' years worked, clinical background | 1 month from enrollment to consultation |
| Participant characteristics | Young adults: 7 items (self-developed): Age, gender, household situation, socioeconomic status, comorbidity, level of education13 Clinicians: 2 items (self-developed): Age, gender. | 4 months from enrollment to last questionnaire |
| Diabeter | Rotterdam | South Holland | 3011TA | Netherlands |
|
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |