Type 1 Diabetes
Conditions
Keywords
Make Care Fit, young adults, type 1 diabetes, qualitative research
Brief summary
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: * Take part in an observed clinical encounter with their clinician * Participate in a post-encounter video-stimulated interview reflecting on the consultation * Complete questionnaires about their experiences of the consultation
Interventions
BEHAVIORALMaking Care Fit tool
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.
OTHERCare as usual
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.
Sponsors
Leiden University Medical Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 30 Years
Healthy volunteers
No
Inclusion criteria
* Young adults (age 18-30) * with ≥1 year since the diagnosis of type 1 diabetes * receiving ongoing treatment at participating diabetes clinics (Leiden university medical center (LUMC), Diabeter), * able to speak and read Dutch * able to provide informed consent for study participation
Exclusion criteria
* People who do not fit the participant requirements * People who cannot give consent themselves (who are incapacitated)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Observable efforts of collaboration to align care and life, with and without using the tool. | 1 month from enrollment to the consultation | Qualitative coding of observations |
| Perceived and unobservable efforts to align care and life. | 2 months from enrollment into the study to the video stimulated interview | Qualitative coding |
| Perceived alignment of care plan and life. | 4 months from enrollment to filling out the last questionnaire | Young adults \& clinicians: Open-ended question: "why does your care plan make sense?" |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Perceived clinical empathy | 1 month from enrollment to after the consultation | Young adults: Consultation And Relational Empathy (CARE) measure, 10 items to be scored on a 1-5 scale. |
| Written information by patient in making care fit tool | 1 month from enrollment to having the consultation | Qualitative coding |
| patient involvement | 1 month after enrollment during the clinical consultation | OPTION12 (reported on 0-100 scale) with a higher score being more patient involvement |
| Perceived treatment burden, and acceptability of this burden. | 4 months from enrollment to filling out the last questionnaire | Young adults: Treatment Burden Questionnaire (TBQ), 15 items to be scored on a 0-10 scale; 1 item on acceptability of burden. |
| Variety and quality of themes discussed | 1 month from enrollment to consultation | Quantitative coding of observations, self-developed |
| Collaborative care plan design | 1 month from enrollment to consultation | SDMo (reported on 1-10 scale) with higher scores suggesting more collaborative behaviours |
| Fidelity of the use of the Making Care Fit tool | 1 month from enrollment to the consultation | Quantitative coding of observations, self-developed |
| Unhurried conversations | 1 month from enrollment to consultation | Unhurried Collaboration Assessment Tool (UCAT), 37 items to be scored on a 1-5 scale. |
| Perceived diabetes distress | 4 months from enrollment to filling out the last questionnaire | Young adults: Diabetes distress scale (DDS) screening instrument, 2 items to be scored on a 1-6 scale. |
| Self-reported fidelity of using the Making Care Fit tool outside of the clinical encounter | 1 month from enrollment to concluding the consultation | Young adults \& clinicians: 3 items about fidelity and and acceptability |
Countries
Netherlands
Contacts
CONTACTMarleen Kunneman, PhD
Outcome results
None listed