The CareWell-programme for Community-dwelling Frail Elderly Persons.

Overall Functioning Clinical Trial

— CareWell  

Official title:

Towards a CARE AND WELFARE STANDARD for Community-dwelling Frail Elderly People With Complex Health Problems

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01499797
• Other study ID #: 2010/403
• Status: Completed
• Phase: N/A
• First received: October 20, 2011
• Last updated: June 6, 2013
• Start date: January 2011
• Est. completion date: March 2013

Study information

• Verified date: October 2011
• Source: Radboud University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: ZonMw, Netherlands Organisation for Health Research and Development
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 536
• Est. completion date: March 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 70 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Incremental Cost-effectiveness Ratio
• Overall Functioning

Intervention

Other:
• The CareWell programme
The CareWell programme contains the following components: multidisciplinary primary care teams working with proactive care plans integrating cure, care and welfare advanced care planning (e.g. recording limitations of treatment, non-resuscitation decisions) medication review case-management guidelines for consultation of in-hospital geriatric experts guidelines for transfers from primary care to home-based facilities and hospital and back practice guidelines for management of common geriatric conditions

Locations

Country	Name	City	State
Netherlands	Huisartsengroep Milbergen (van der Ligt/ Krijgsman), Oude Gracht 16	Beek-Ubbergen
Netherlands	Gezondheidscentrum de Kroonsteen, Schoolstraat 8	Malden
Netherlands	Gezondheidscentrum de Vuursteen, Prinsenweg 6	Molenhoek
Netherlands	Gezondheidscentrum Hazenkamp, Vossenlaan 76	Nijmegen
Netherlands	Huisartsenpraktijk Danielsplein, Danielsplein 4	Nijmegen
Netherlands	Huisartsenpraktijk de Haterse HOED, Couwenbergstraat 34-36	Nijmegen
Netherlands	Huisartsenpraktijk Jacobslaan (Dreijerink/ van der Laan-Evers), Jacobslaan 345	Nijmegen
Netherlands	Medisch Centrum Brakkenstein, Kanunnik Boenenstraat 8	Nijmegen
Netherlands	Medipark (Graat), Hyacinthstraat 3a	Uden
Netherlands	Huisartsenpraktijk Ubachs/Vogels, Huissteden 1450	Wijchen

Sponsors (6)

Lead Sponsor	Collaborator
Radboud University	City of Nijmegen, Dutch Healthcare Authority, Health insurances CZ, Health insurances UVIT, ZonMw: The Netherlands Organisation for Health Research and Development

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall functioning	Overall functioning is measured with the Katz-15 questionnaire. Katz-15 is embedded in the minimal data set (MDS). This MDS is used by all research projects of the Dutch National Program on Elderly Care	18 months	No
Primary	Incremental cost-effectiveness ratio (ICER)		18 months	No
Secondary	Perceived quality of life	Perceived quality of life is measured with the RAND-36 questionnaire. RAND-36 is embedded in the minimal data set (MDS). This MDS is used by all research projects of the Dutch National Program on Elderly Care	18 months	No
Secondary	Psychological well-being	Psychological well-being is measured with the RAND-36 questionnaire.	18 months	No
Secondary	Social functioning	Social functioning is measured with the RAND-36 questionnaire.	18 months	No
Secondary	Perceived health	Perceived health is measured with the RAND-36 questionnaire abd Cantril's Self Anchoring Ladder. Both RAND-36 as Cantril's Self Anchoring Ladder are embedded in the minimal data set (MDS).	18 months	No
Secondary	Utility	Utility is measured with the EQ-5D questionnaire. EQ-5D is embedded in the minimal data set (MDS).	18 months	No
Secondary	Health care consumption	Health care consumption including hospital resource consumption, unplanned GP care (evenings, nights and weekends), home care, temporary or permanent admission to a residential care home, temporary or permanent admission to a nursing home, day care, visits to outpatients'clinics.	18 months	No
Secondary	Use of welfare services		18 months	No