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Integrated CareKCEHR2020-02NCT04639908

Federal Knowledge Centre for Health Care

An observational study of Integrated Care, run by Universitair Ziekenhuis Brussel.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

In order to prepare for the ageing population and its impact on the health care system, the National Institute for Sickness and Disability Insurance in Belgium (RIZIV) launched in 2010 a subsidy programme (called Protocol 3) for innovative projects aimed at care and support for vulnerable older people with complex… Read more about this study

Who is it for?
Ages 60 years and olderHealthy volunteers can take part
Conditions the study is for
Integrated Care
What is being tested?
Interview
How many people
12 participants
Where
No sites listed yet
Study dates
1 Dec 2020to 9 Apr 2021
Phase
Observational
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 60 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: patients who profit from the interventions offered by Protocol 3

Who may be able to join

  • uses interventions of protocol 3 projects

Who cannot join

  • -

Trial locations and contacts

No sites are listed yet.

Melissa Desmedt, PhD contact

+32474686299

melissa.desmedt@mobius.eu

Esther Chevalier, Master contact

+32472221623

esther.chevalier@mobius.eu

About this study

In order to prepare for the ageing population and its impact on the health care system, the National Institute for Sickness and Disability Insurance in Belgium (RIZIV) launched in 2010 a subsidy programme (called Protocol 3) for innovative projects aimed at care and support for vulnerable older people with complex care needs. The objective of these projects is to reduce the risk and need for admission to a care institution/residential care centre. These are alternative and supportive forms of care for the elderly for which there is currently no allowance, which enable vulnerable older people to be cared for at home, which have a positive influence on the evolution of the older person's state of health and which improve the quality of life, which do not entail higher costs than those of a classic admission and which are scientifically evaluated.

These Protocol 3 projects focus on vulnerable elderly people who are not admitted to a residential care centre, but who are at risk of a complex and/or long-term care situation. As a result of the complex care situation, there is also a great need for coordinated care between different care providers and/or there will also be supportive forms of care that ensure continuity of care. The expected added value of the care innovation projects should focus on: the importance of consultation and cooperation between the various stakeholders, the means to improve the competences of all relevant stakeholders, the means to organise customised care and the means to achieve continuity of care for the patient. The objective of the current study is to evaluate the phase 2 interventions, in particular: the adapted interventions case management and occupational therapy; and the newly introduced interventions in phase 3: health education, educational sessions for informal care providers and control visits at night.

Read the detailed description

In order to prepare for the ageing population and its impact on the health care system, the National Institute for Sickness and Disability Insurance in Belgium (RIZIV) launched in 2010 a subsidy programme (called Protocol 3) for innovative projects aimed at care and support for vulnerable older people with complex care needs. The objective of these projects is to reduce the risk and need for admission to a care institution/residential care centre. These are alternative and supportive forms of care for the elderly for which there is currently no allowance, which enable vulnerable older people to be cared for at home, which have a positive influence on the evolution of the older person's state of health and which improve the quality of life, which do not entail higher costs than those of a classic admission and which are scientifically evaluated.

These Protocol 3 projects focus on vulnerable elderly people who are not admitted to a residential care centre, but who are at risk of a complex and/or long-term care situation. As a result of the complex care situation, there is also a great need for coordinated care between different care providers and/or there will also be supportive forms of care that ensure continuity of care. The expected added value of the care innovation projects should focus on: the importance of consultation and cooperation between the various stakeholders, the means to improve the competences of all relevant stakeholders, the means to organise customised care and the means to achieve continuity of care for the patient. The objective of the current study is to evaluate the phase 2 interventions, in particular: the adapted interventions case management and occupational therapy; and the newly introduced interventions in phase 3: health education, educational sessions for informal care providers and control visits at night.

After all, an evaluation at the end of these projects is important in order to evaluate the added value of these care innovation projects and how they can possibly be structurally anchored. The starting point of this study is to learn in a qualitative way about the perceptions and experiences of patients and their informal carers about the benefits of the interventions, the barriers and facilitating factors of their implementation and the potential for improvement of these initiatives. The objective is to assess the extent to which patient needs are met by the interventions and what can be improved to consolidate the intervention or add more value to it.

Conditions
Integrated Care
Being tested
Interview
Keywords
elderly care, primary care, belgium

What participants receive

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

  • InterviewOther

    interview with patient

Study groups in NCT04639908
Study groupRoleWhat they receive
barriersfind out what are the barriers
Receives: Other: Interview
facilitatorsfind out what are the facilitators
Receives: Other: Interview

What is being measured

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

  1. incidence of falling at home

    interview

    Measured: 8 months

  2. admission in nursing home

    interview

    Measured: 8 months

Timeline

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

  1. First posted23 Nov 2020
  2. Study start1 Dec 2020 (estimated)
  3. Primary completion9 Apr 2021 (estimated)
  4. Study completion9 Apr 2021 (estimated)

Resources

More details

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

Study design
Study type
Observational
Observational model
Other
Time perspective
Other
Enrolment
12 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04639908
Sponsor's protocol ID
KCE
Acronym
KCEHR2020-02
Status last verified
Oct 2020
First submitted
23 Oct 2020
Last updated
23 Nov 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Integrated Care, run by Universitair Ziekenhuis Brussel.

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 1 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 23 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

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 Melissa Desmedt, PhD (+32474686299, melissa.desmedt@mobius.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

incidence of falling at home (time frame: 8 months). The study lists 2 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 23 Nov 2020.

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