Integrated CareKCEHR2020-02NCT04639908
Federal Knowledge Centre for Health Care
An observational study of Integrated Care, run by Universitair Ziekenhuis Brussel.
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.
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 group | Role | What they receive |
|---|---|---|
| barriers | find out what are the barriers Receives: Other: Interview | |
| facilitators | find 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.
incidence of falling at home
interview
Measured: 8 months
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.
- First posted23 Nov 2020
- Study start1 Dec 2020 (estimated)
- Primary completion9 Apr 2021 (estimated)
- Study completion9 Apr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Integrated CareStudies of the same condition, open and under way.
- More trials run by Universitair Ziekenhuis BrusselThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Justien Cornelis, PhD, Principal investigator, KCE
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
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Federal Knowledge Centre for Health Care
- ClinicalTrials.gov ID
- NCT04639908
- Acronym / sponsor ID
- KCEHR2020-02 / KCE
- Conditions
- Integrated Care
- Keywords
- elderly care, primary care, belgium
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Study start
- 1 Dec 2020 (estimated)
- Primary completion
- 9 Apr 2021 (estimated)
- Study completion
- 9 Apr 2021 (estimated)
- First posted
- 23 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| barriers | – | Other: Interviewfind out what are the barriers |
| facilitators | – | Other: Interviewfind out what are the facilitators |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patients who profit from the interventions offered by Protocol 3
Key inclusion criteria (1 listed)
- uses interventions of protocol 3 projects
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interviewinterview with patient | Other | barriers, facilitators |
Primary outcome
incidence of falling at home
Time frame: 8 months
interview
admission in nursing home
Time frame: 8 months
interview
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Justien Cornelis, PhD principal investigator
KCE
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.