About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
People who do not fit the participant requirements
People who cannot give consent themselves (who are incapacitated)
Trial design
Parallel
Treatments tested in this trial
Making Care Fit tool
BehavioralA 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.
Care as usual
Other interventionParticipants 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.
Treatment groups
Trial outcomes
Primary outcomes
Observable efforts of collaboration to align care and life, with and without using the tool.
Qualitative coding of observations
Perceived and unobservable efforts to align care and life.
Qualitative coding
Perceived alignment of care plan and life.
Young adults \& clinicians: Open-ended question: "why does your care plan make sense?"
Secondary outcomes
Variety and quality of themes discussed
Quantitative coding of observations, self-developed
Collaborative care plan design
SDMo (reported on 1-10 scale) with higher scores suggesting more collaborative behaviours
Fidelity of the use of the Making Care Fit tool
Quantitative coding of observations, self-developed
Unhurried conversations
Unhurried Collaboration Assessment Tool (UCAT), 37 items to be scored on a 1-5 scale.
Other outcomes
Consultation characteristics
Encounter duration, diabetes clinic, consultation type (in-person or digital)
Diabetes-specific characteristics
8 items (self-developed): Treatment regime, year of diagnosis, events of ketoacidosis and hypoglycaemia, HbA1c.
Consultation characteristic
1 item (self-developed: Duration of patient/clinician relationship in years
Work-related characteristics
2 items (self-developed): Clinicians' years worked, clinical background
Sponsors and contacts
Click on the lead sponsor to view all of their trials.