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Chronic ConditionEMBOSSNCT05972031

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

A study testing Person-centred integrated care intervention in people with Chronic Condition and Chronic Conditions, Multiple, run by Radboud University Medical Center at 1 site in Netherlands.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Person-centred integrated care intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
540 participants
Where
1 siteNetherlands
Study dates
29 Jan 2023to 1 Aug 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Currently enrolled in any of the single disease management programmes (usual care) for DM2, COPD, asthma or CVD

Who cannot join

  • Limited life expectancy (less than 3 months)
  • Patients with high level of SES (or educational level > MBO2)

Trial locations and contacts

1 site in 1 country.

Hester Van Bommel, MSc contact

+31302349800

hester.vanbommel@radboudumc.nl

Netherlands1 site, 1 recruiting
  • RadboudUMC

    Nijmegen

    Hester Van Bommel, MSc, +31302349800, hester.vanbommel@radboudumc.nl

    Recruiting

Other trials in Netherlands

About this study

Official title: EMBOSS: Reach and Effect of a Person-centred Integrated-care Approach for Chronic Diseases and MultimorBidity in Patients of Low sOcio- Economic StatuS in General Practice

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.

Read the detailed description

In the Netherlands, 28% of the population is lowly educated, i.e. the level of education is MBO1 (secondary vocational education) or lower, which is the main indicator of low socioeconomic status. Low-educated people suffer 2-4 times more often than high-educated people from diabetes mellitus, COPD, coronary disease (often in combination) and of the risk factors contributing to these diseases. The healthy life-expectancy for low educated people is 14 years shorter, the health outcomes are worse (more complications of cardiovascular diseases and diabetes), because of high levels of chronic stress due to challenging living circumstances, negatively influencing self-confidence and executive functions, limited health and digital literacy - all determinants of effective self-management. Most people with chronic diseases are being cared for in general practice (GP). However, professionals in GP often struggle with the care for low-educated patients, experiencing difficulties in recognizing patients with low (health) literacy, and in adapting communication and advice to the needs of this group. Low-educated patients more often visit the GP, and are more often referred to costly secondary care.

Many interventions for chronic diseases fail to show effectiveness in low-SES groups. The reasons are multiple:

  1. materials and procedures used are too complicated,
  2. daily survival sets different priorities,
  3. communication and approach by healthcare professionals don't suit the needs and skills of this population, actions or materials are too expensive.

Effectiveness of interventions can be improved by involving low-SES patients in the development and by training healthcare professionals. Low-educated patients should be explicitly recruited in intervention evaluation studies as this population is underrepresented in clinical studies, which impedes generalizability of results. Chronic care for patients with diabetes mellitus type 2 (DM2), COPD and/or cardiovascular diseases (CVD) in GP is carried out through disease management programmes. However, major limitations of these programmes are that it focused on a single disease, while half of the patients suffers from multimorbidity. Also, the programmes do not truly reflect the needs of patients who experience this disease management as fragmented with too little attention for the partienst personal context. Therefore, a more generic disease management (GDM) programme including a person-centred and integrated-care (PC-IC) approach seems to be a promising strategy. Such an approach puts the patient at the centre of care, tailoring chronic care to the individual's needs and addressing all the issues important to him. It starts with a comprehensive biopsychosocial assessment of all relevant problems. Subsequently, a personalised treatment plan is made with individualised goals, actions and professionals involved. The programme responds to the needs and context of the 'whole' patient to provide the right care in the right place at the right time. It supposes to stimulate patient's self-management.

Currently, in the Netherlands, some regional projects with GDM programmes and PC-IC approaches are running, of which 'OPTIMA FORMA' may be the best known. This project started in 2018 and consists of three stages in which a GDM programme including a PC-IC approach is developed, tested and evaluated in three large Dutch primary care cooperatives, i.e Nijmegen, Arnhem, and Doetinchem. However, in 'OPTIMA FORMA' as in other ongoing projects, there is no specific attention for or involvement of people with low SES. This will obviously reduce the effectiveness of this approach in low SES patients, as one third of the population with chronic diseases consists of patients with low SES. The investigators there is an urgent need for PC-IC interventions that specifically address the needs of low SES population in order to be effective. Therefore, the investigators supported the three primary care cooperatives who participate in OPTIMA FORMA with the development of a GDM programme specifically for low SES patients. With help from patients with low SES and the healthcare professionals of the low SES patient, the investigators collected information on experiences, facilitators, and barriers from the previously conducted pilot study of OPTIMA FORMA PHASE2 (CMO 2021-8106).

The investigators used this information in co-creation sessions with patients with low SES and healthcare professionals to adjust the OPTIMA FORMA programme to a GDM programme that better suits the needs of low SES patients (EMBOSS programme).

The hypothesise off the EMBOSS programme will not only result in better outcomes of care in this group (and thus decreasing socio-economic health disparities), but also to a more effective role of GPs and practice nurses with more work satisfaction and less workload. In the current study our primary research question is:

What is the effectiveness of the EMBOSS intervention, i.e. a GDM programme including a PC-IC approach developed with and for low SES people with one or more chronic diseases compared to care as usual, i.e. SDM programmes for DM2, COPD and/or CVD in general practice? The investigators will perform a cluster randomized controlled trial with a follow-up time of 12 months.

Being tested
Person-centred integrated care intervention
Keywords
Primary care, Person-centered, Integrated-care, Health literacy, Health disparities, Socio-economic status, General practice
Medical subject headings
Chronic Disease, Multiple Chronic Conditions

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Person-centred integrated care interventionBehavioural

    Also called Usual care

    See arm description.

Study groups in NCT05972031
Study groupRoleWhat they receive
Person-centred integrated care interventionExperimentalThe core of the person-centered approach is a cyclical process and for EMBOSS developed for patients with low SES. The practice nurse in the GP will act as case manager and can consult other health providers. The first step in the intervention is assessing the integral health status of the patient (health across multiple domains), using a visual conversation tool. The second step is discussing the results with the patient. Personal goals are formulated in the third step. In the fourth step, the healthcare professional and patient will choose through shared-decision making the most appropriate interventions and support to achieve these goals, which are documented in a personal plan. Next, referrals are made if necessary and the treatment is started. An evaluation is planned and carried out. All practices in the EMBOSS intervention group will be trained by Pharos on how to recognize and provide GDM to low SES patients using appropriate communication skills and the specific tools.
Receives: Behavioral: Person-centred integrated care intervention
Usual careNo interventionPractices in the control group provide care as usual, which consists of the SDM programmes according to the national care standards and General Practice guidelines (NHG) for DM2, COPD and CVD. According to these protocolised programmes, patients with COPD, CVD or DM2 visit their general practice at a standard frequency per year (1 - 4 times) and standard monitoring measurements and topics are discussed. The practices that are randomised to the control group will not receive any additional training related to this study.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. patient-reported health-related quality of life Physical Health

    Global Physical Health [Time Frame: Baseline, 6 months, 12 months] Physical aspect of health-related quality of life as measured by the PROMIS-Global 10 instrument (T-scores; higher T-score indicates better physical aspect of HrQoL) Promis 10 is a patient-reported questionnaire in which the response options are presented as 5-point (as well as a single 11-point) rating scales.

    Measured: 12 months

  2. patient-reported health-related quality of life Mental health

    Global Mental Health [Time Frame: Baseline, 6 months, 12 months] Mental aspect of health-related quality of life as measured by the PROMIS-Global 10 instrument (T-scores; higher T-score indicates better mental aspect of HrQoL) Promis 10 is a patient-reported questionnaire in which the response options are presented as 5-point (as well as a single 11-point) rating scales.

    Measured: 12 months

  3. Patient-experienced quality of care

    atient-experienced quality of care [Time Frame: Baseline, 6 months, 12 months] Person-centredness of care as measured by the Person Centred Coordinated Care Experience Questionnaire (P3CEQ) instrument; minimum score 0, maximum score 30, higher score equals better P3CE.

    Measured: 12 months

Secondary outcomes (9)
  1. Patient activation as measured by PAM

    Patient activation as measured by the Patient Activation Measure instrument; minimum 0, maximum 100, higher score equals better patient activation.

    Measured: Baseline, 6 months, 12 months

  2. Health-related quality of life as measured by the EQ-5D-5L instrument

    Health-related quality of life as measured by the EQ-5D-5L instrument; minimum 0, maximum 1, higher score equals better HrQoL

    Measured: Baseline, 6 months, 12 months

  3. BMI

    Combined length and weight according to general practice data (registered for normal care)

    Measured: Baseline, 6 months, 12 months

  4. HbA1c

    according to general practice data

    Measured: Baseline, 6 months, 12 months

  5. Blood glucose

    according to general practice data

    Measured: Baseline, 6 months, 12 months

  6. Blood LDL-cholesterol

    according to general practice data

    Measured: Baseline, 6 months, 12 months

  7. Systolic and diastolic blood pressure

    according to general practice data

    Measured: Baseline, 6 months, 12 months

  8. Positive affect of healthcare providers

    Satisfaction with job according to selection of MAS-GZ instrument (minimum 8, maximum 40, higher score indicates higher positive affect)

    Measured: Baseline, 6 months, 12 months

  9. Experience of healthcare providers

    Satisfaction with job according to selection of CO-PILOT instrument (minimum 1, maximum 10, higher score is better experience of healthcare providers)

    Measured: Baseline, 6 months, 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Aug 2023
  2. Study start29 Jan 2023
  3. Primary completion1 Aug 2024 (estimated)
  4. Study completion1 Aug 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Cluster randomized controlled trial
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
540 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05972031
Sponsor's protocol ID
2022-15786
Acronym
EMBOSS
Status last verified
Feb 2023
First submitted
6 Feb 2023
Last updated
6 Sep 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Person-centred integrated care intervention in people with Chronic Condition and Chronic Conditions, Multiple, run by Radboud University Medical Center at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 6 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Hester Van Bommel, MSc (+31302349800, hester.vanbommel@radboudumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

patient-reported health-related quality of life Physical Health (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2023.

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