Making Diabetes Care Fit for Young Adults Living With Type 1 Diabetes: Observations, Reflections and Expert Opinions

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-30
SponsorLeiden University Medical Center

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • 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.

  • Care as usual

    Other intervention

    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.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Care as usualOther 1 intervention
Group B: Make Care Fit toolExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Observable efforts of collaboration to align care and life, with and without using the tool.

Qualitative coding of observations

Time frame
1 month from enrollment to the consultation
2

Perceived and unobservable efforts to align care and life.

Qualitative coding

Time frame
2 months from enrollment into the study to the video stimulated interview
3

Perceived alignment of care plan and life.

Young adults \& clinicians: Open-ended question: "why does your care plan make sense?"

Time frame
4 months from enrollment to filling out the last questionnaire

Secondary outcomes

1

Variety and quality of themes discussed

Quantitative coding of observations, self-developed

Time frame
1 month from enrollment to consultation
2

Collaborative care plan design

SDMo (reported on 1-10 scale) with higher scores suggesting more collaborative behaviours

Time frame
1 month from enrollment to consultation
3

Fidelity of the use of the Making Care Fit tool

Quantitative coding of observations, self-developed

Time frame
1 month from enrollment to the consultation
4

Unhurried conversations

Unhurried Collaboration Assessment Tool (UCAT), 37 items to be scored on a 1-5 scale.

Time frame
1 month from enrollment to consultation

Other outcomes

1

Consultation characteristics

Encounter duration, diabetes clinic, consultation type (in-person or digital)

Time frame
1 month from enrollment to consultation
2

Diabetes-specific characteristics

8 items (self-developed): Treatment regime, year of diagnosis, events of ketoacidosis and hypoglycaemia, HbA1c.

Time frame
4 months from enrollment to last questionnaire filled out
3

Consultation characteristic

1 item (self-developed: Duration of patient/clinician relationship in years

Time frame
4 months from enrollment to last questionnaire
4

Work-related characteristics

2 items (self-developed): Clinicians' years worked, clinical background

Time frame
1 month from enrollment to consultation

Sponsors and contacts

Click on the lead sponsor to view all of their trials.