NCT04639908

Brief 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 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
12

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2020

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 23, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 23, 2020

Completed
8 days until next milestone

Study Start

First participant enrolled

December 1, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 9, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 9, 2021

Completed
Last Updated

November 23, 2020

Status Verified

October 1, 2020

Enrollment Period

4 months

First QC Date

October 23, 2020

Last Update Submit

November 16, 2020

Conditions

Keywords

elderly careprimary carebelgium

Outcome Measures

Primary Outcomes (2)

  • incidence of falling at home

    interview

    8 months

  • admission in nursing home

    interview

    8 months

Study Arms (2)

barriers

find out what are the barriers

Other: Interview

facilitators

find out what are the facilitators

Other: Interview

Interventions

interview with patient

barriersfacilitators

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients who profit from the interventions offered by Protocol 3

You may qualify if:

  • uses interventions of protocol 3 projects

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Interviews as Topic

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Justien Cornelis, PhD

    KCE

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Melissa Desmedt, PhD

CONTACT

Esther Chevalier, Master

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 23, 2020

First Posted

November 23, 2020

Study Start

December 1, 2020

Primary Completion

April 9, 2021

Study Completion

April 9, 2021

Last Updated

November 23, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share