- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04639908
Federal Knowledge Centre for Health Care (KCEHR2020-02)
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.
Study Overview
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 Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Melissa Desmedt, PhD
- Phone Number: +32474686299
- Email: melissa.desmedt@mobius.eu
Study Contact Backup
- Name: Esther Chevalier, Master
- Phone Number: +32472221623
- Email: esther.chevalier@mobius.eu
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- uses interventions of protocol 3 projects
Exclusion Criteria:
-
Study Plan
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Other
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
barriers
find out what are the barriers
|
interview with patient
|
facilitators
find out what are the facilitators
|
interview with patient
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
incidence of falling at home
Time Frame: 8 months
|
interview
|
8 months
|
admission in nursing home
Time Frame: 8 months
|
interview
|
8 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Justien Cornelis, PhD, KCE
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- KCE
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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