NCT05972031: EMBOSS

EMBOSS A Person-centred Integrated-care for Chronic Diseases in Patients of Low Socio Economic Status

Status unknown NA Last updated 6 September 2023

What this trial tests

NA trial testing Person-centred integrated care intervention in Chronic Condition in 540 participants. Status unknown.

Timeline

29 January 2023

Primary endpoint
1 August 2024

1 August 2024

Quick facts

Lead sponsor	Radboud University Medical Center
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	540
Start date	29 January 2023
Primary completion	1 August 2024
Estimated completion	1 August 2024
Sites	1 location across Netherlands

Drugs / interventions tested

• Person-centred integrated care intervention

Conditions studied

• Chronic Condition — all drugs for Chronic Condition →
• Chronic Conditions, Multiple — all drugs for Chronic Conditions, Multiple →

Sponsor

Radboud University Medical Center

Who can join

18 and older, any sex, with Chronic Condition or Chronic Conditions, Multiple. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

People of low socio economic status (SES) more often than others suffer from chronic diseases like diabetes mellitus, chronic obstructive pulmonary disease (COPD), or coronary diseases. Compared to others People of low SES more often have to deal with multiple diseases (multimorbidity) and experience worse health outcomes. The health literacy of people of low SES is often low. Current chronic disease management programs focus on reducing the burden of a single disease by prescribing medication, protocoled monitoring routines, or lifestyle advice.

However, the effectiveness of these interventions is low in people with low SES, as the interventions insufficiently take into account the specific problems and needs of this (multimorbid) population. A person-centered and integrated-care approach, that puts the patient at the center of care instead of the disease and in which care is tailored to the individual patient with chronic disease(s), seems to be more appropriate, but only when low SES people are closely involved in the development, testing, and evaluation of such an approach. Also, certain preconditions should be met, such as training of specific knowledge and skills of the healthcare professionals involved.

In the EMBOSS project, the investigators will develop, test, evaluate, and implement a person-centered integrated-care approach for and in close collaboration with people with low SES who have one or more chronic diseases. Thus, the EMBOSS study will have the potential to reducing health disparities in this group, to broadening the action perspectives of general practitioners and practice nurses for an increasing diverse patient population and to a better fit of lifestyle interventions in people of low SES.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Co-creating a person-centred approach in primary care for patients with low socioeconomic status and chronic conditions: <i>a participatory learning & action study</i>.
   van Bommel HE, van den Muijsenbergh METC, Bergsma B, Burgers JS, et al · · 2025 · cited 1× · PMID 40977445 · DOI 10.1017/s1463423625100431
2. Optimizing Study Design for Evaluating Complex Interventions: An Example of a Feasibility Study in Person-Centered and Integrated Chronic Disease Care in Dutch General Practice.
   Raaijmakers LHA, Schermer TR, van Bommel HE, Vercoulen JH, et al · · 2025 · PMID 41209624 · DOI 10.5334/ijic.8998