Clinical trial NCT01499797: The CareWell-programme for Community-dwelling Frail Elderly Persons.
Official title: Towards a CARE AND WELFARE STANDARD for Community-dwelling Frail Elderly People With Complex Health Problems
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overall Functioning
Incremental Cost-effectiveness Ratio
Keywords: frailty
frail elders
multicomponent intervention
overall functioning
cost-effectiveness
integrated care
primary care
community dwelling
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: ZonMw: The Netherlands Organisation for Health Research and Development
name: Dutch Healthcare Authority
name: Health insurances CZ
name: Health insurances UVIT
name: City of Nijmegen
First posted: 2011-12-26
Enrollment: 536
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to investigate the effect of the CareWell-programme on overall functioning of community-dwelling frail elderly persons. Furthermore, the total costs and the cost-effectiveness of the CareWell-programme, in comparison with regular medical care, will be studied.


Eligibility criteria: Inclusion Criteria:

* Frail community dwelling elderly patients aged 70 years or above. Frailty is determined with a two-phase screening instrument.

Exclusion Criteria:

* Non-frail elders
* Patients in palliative or end-of-life stages of disease
* Patients residing in long-term care facilities (care homes and nursing homes)
* Patients already enrolled in specific dementia-related case-management programmes who lack other health-related problems
* Patients not speaking or understanding the Dutch language

Primary outcomes:
measure: Overall functioning
timeFrame: 18 months
measure: Incremental cost-effectiveness ratio (ICER)
timeFrame: 18 months
Secondary outcomes:
measure: Perceived quality of life
timeFrame: 18 months
measure: Psychological well-being
timeFrame: 18 months
measure: Social functioning
timeFrame: 18 months
measure: Perceived health
timeFrame: 18 months
measure: Utility
timeFrame: 18 months
measure: Health care consumption
timeFrame: 18 months
measure: Use of welfare services
timeFrame: 18 months
Other outcomes:
Locations:
city: Beek-Ubbergen
country: Netherlands
facility: Huisartsengroep Milbergen (van der Ligt/ Krijgsman), Oude Gracht 16
city: Malden
country: Netherlands
facility: Gezondheidscentrum de Kroonsteen, Schoolstraat 8
city: Molenhoek
country: Netherlands
facility: Gezondheidscentrum de Vuursteen, Prinsenweg 6
city: Nijmegen
country: Netherlands
facility: Medisch Centrum Brakkenstein, Kanunnik Boenenstraat 8
city: Nijmegen
country: Netherlands
facility: Gezondheidscentrum Hazenkamp, Vossenlaan 76
city: Nijmegen
country: Netherlands
facility: Huisartsenpraktijk Jacobslaan (Dreijerink/ van der Laan-Evers), Jacobslaan 345
city: Nijmegen
country: Netherlands
facility: Huisartsenpraktijk de Haterse HOED, Couwenbergstraat 34-36
city: Nijmegen
country: Netherlands
facility: Huisartsenpraktijk Danielsplein, Danielsplein 4
city: Uden
country: Netherlands
facility: Medipark (Graat), Hyacinthstraat 3a
city: Wijchen
country: Netherlands
facility: Huisartsenpraktijk Ubachs/Vogels, Huissteden 1450
Study officials:
affiliation: Radboud University Medical Center
name: Raymond Koopmans, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ruikes FGH, Adang EM, Assendelft WJJ, Schers HJ, Koopmans RTCM, Zuidema SU. Cost-effectiveness of a multicomponent primary care program targeting frail elderly people. BMC Fam Pract. 2018 May 16;19(1):62. doi: 10.1186/s12875-018-0735-4.
citation: Ruikes FG, Meys AR, van de Wetering G, Akkermans RP, van Gaal BG, Zuidema SU, Schers HJ, van Achterberg T, Koopmans RT. The CareWell-primary care program: design of a cluster controlled trial and process evaluation of a complex intervention targeting community-dwelling frail elderly. BMC Fam Pract. 2012 Dec 5;13:115. doi: 10.1186/1471-2296-13-115.